Effect of a Novel Omega-3 and Omega-6 Fatty Acid Supplement on Dry Eye Disease: A 3-month Randomized Controlled Trial.

SIGNIFICANCE: Supplementing diet with a novel combination of omega-3 and omega-6 fatty acids significantly improved symptoms in extremely symptomatic participants with dry eye disease (DED). PURPOSE: This study aimed to determine the effect of daily intake of a novel combination of essential fatty acids on signs and symptoms of DED. METHODS: Participants with moderate to severe DED were enrolled in a prospective, randomized, double-masked parallel group study. Participants ingested either the treatment supplement containing omega-3 and omega-6 fatty acids (1200 mg eicosapentaenoic acid, 300 mg docosahexaenoic acid, 150 mg γ-linoleic acid) or the placebo (coconut and olive oil) daily for 3 months. To determine compliance, Omega-3 Index blood tests were conducted. At baseline and at 1 and 3 months, the following assessments were conducted: Ocular Surface Disease Index (OSDI) questionnaire and Symptom Assessment Questionnaire in Dry Eye, noninvasive tear breakup time, tear meniscus height, tear osmolarity, ocular redness, surface staining, Schirmer test, and meibography. RESULTS: Fifty participants (mean ± standard deviation baseline OSDI score, 52.2 ± 16.5) completed the study: 24 randomized to treatment and 26 randomized to placebo. Although there was an improvement in OSDI score at 3 months for both groups (treatment: -13.4 points, P = .003; placebo: -7.8 points, P = .02), participants with baseline OSDI scores >52 demonstrated an even larger significant improvement in symptoms with the treatment at 3 months compared with baseline (n = 13, -20.8 points, P = .002). There were no significant changes in any of the ocular assessments at 1 or 3 months (all P > .05). After 3 months, Omega-3 Index increased by 34% in the treatment group (baseline, 5.3 ± 0.8; 3 months, 8.0 ± 2.1; P < .001) and did not change in the placebo group (baseline, 4.8 ± 0.8; 3 months, 4.8 ± 0.6; P = .95). CONCLUSIONS: Supplementation with eicosapentaenoic acid, docosahexaenoic acid, and γ-linoleic acid resulted in a significant and clinically meaningful improvement of dry eye symptoms in extremely symptomatic participants with DED (OSDI ≥52).

The Impact of Incubation Conditions on In Vitro Phosphatidylcholine Deposition on Contact Lens Materials.

SIGNIFICANCE: Previous in vitro measurements of contact lenses commonly investigate the impact of nonpolar tear film lipids (i.e., sterols). Polar lipids, however, are equally important stabilizing components of the tear film. This research explores and presents further knowledge about various aspects of polar lipid uptake that may impact contact lens performance. PURPOSE: This study evaluated the impact of incubation time, lipid concentration, and replenishment of an artificial tear solution (ATS) on the uptake of phosphatidylcholine (PC) onto conventional hydrogel (CH) and silicone hydrogel (SH) contact lens materials. METHODS: Four SHs and two CH lens materials (n = 4) were soaked in a complex ATS containing radioactive 14C-PC as a probe molecule. Phosphatidylcholine uptake was monitored at various incubation time points (1, 3, 7, 14, and 28 days), with different ATS lipid concentrations (0.5×, 1×, 2×) and with and without regular replenishment of the ATS. Phosphatidylcholine was extracted from the lenses, processed, and counted by a ß counter, and accumulated PC (µg/lens) was extrapolated from standard lipid calibration curves. RESULTS: All materials exhibited increasing PC deposition over time. Conventional hydrogel materials showed significantly lower PC uptake rates (P < .001) than any of the SH materials. Increasing lipid concentration in the ATS resulted in increased PC binding onto the contact lens materials (P < .001). Replenishing the ATS every other day, however, impacted the PC deposition differently, showing increased binding (P < .001) on CHs and reduced PC deposition for SH materials (P < .001). CONCLUSIONS: Length of incubation, lipid concentration in the ATS, and renewal of the incubation solution all influenced the amount of PC that sorbed onto various lens materials and therefore need to be considered when conducting future in vitro deposition studies.

Topical Review: Bibliometric Analysis of the Emerging Field of Myopia Management.

SIGNIFICANCE: Identification of the most impactful articles, authors, institutions, countries, and journals in myopia management provides a useful baseline reference for clinicians, researchers, and funding agencies in respect of this emerging field.This work aims to assemble publication metrics for myopia management to identify the most impactful articles, authors, institutions, countries, and journals in this emerging field of research. A search of the titles of articles was undertaken on the Scopus database to identify myopia management-related articles. The 25 most highly cited articles were determined from the total list of 1064 articles found. Rank-order lists by count were assembled for the top 25 in each of four categories: authors, institutions, countries, and journals. A subject-specific myopia management-related h-index (hMM-index) was derived for the entire field, in addition to each of the four categories, to serve as measures of impact in the field. Top 15 lists were generated for each category ranked by hMM-index and tabulated for consideration. An article by Christine Wildsoet and colleagues, describing choroidal and scleral mechanisms of compensation for spectacle lenses in chicks, has generated the most citations (412); Earl Smith is the most impactful author (hMM = 19); the University of Houston produces the most impactful articles (hMM = 31); the United States is the most highly ranked country (hMM = 60); and Optometry and Vision Science is the most impactful journal. Although still in its infancy, myopia management is a topic of emerging interest in the clinical and scientific ophthalmic literature. Impactful authors, institutions, countries, and journals are identified. Optometry is revealed as the leading profession in relation to the publication of myopia management-related articles.

Bulbar Redness and Dry Eye Disease: Comparison of a Validated Subjective Grading Scale and an Objective Automated Method.

SIGNIFICANCE: In this study, assessments of conjunctival redness were performed to evaluate whether patients with or without dry eye disease (DED) could be discriminated based on this measure. Our findings suggest that subjectively grading redness by quadrant, as opposed to automated en face measurements, may be more suitable for this purpose. PURPOSE: This study aimed to quantify bulbar redness using the validated bulbar redness (VBR) grading scale and an automated objective method (Oculus Keratograph 5M; K5M) in participants with DED and non-DED controls. METHODS: Participants with DED (Ocular Surface Disease Index score ≥20 and Oxford scale corneal staining ≥2) and controls (Ocular Surface Disease Index score ≤10 and corneal staining ≤1) attended two study visits. In part 1A of visit 1, baseline bulbar redness was graded with the VBR scale in each conjunctival quadrant of both eyes, followed by automated measurements of temporal and nasal redness with the K5M. This was immediately followed by part 1B, during which a topical vasoconstrictor was instilled into both eyes. Redness assessments were repeated 5 and 30 minutes after instillation with both instruments. Participants returned 14 days later for visit 2, where the same assessments as for visit 1A were repeated. RESULTS: Seventy-four participants (50 DED and 24 controls) completed the study. There were statistically significant differences in redness between the DED and control groups when assessed with the VBR scale (14/16 comparisons; all, P < .05), whereas no significant differences in K5M-derived redness between the DED and non-DED groups were found at any location or time point. Both subjective and objective instruments detected statistically significant reductions in redness 5 and 30 minutes after instillation of the vasoconstrictor (all, P < .01). CONCLUSIONS: Although both subjective and objective instruments were sensitive to detecting changes in redness induced by vasoconstriction, statistically significant differences in redness between DED and control groups were only found using the VBR scale.

Frequency of Contact Lens Complications Between Contact Lens Wearers Using Multipurpose Solutions Versus Hydrogen Peroxide in the United States and Canada.

OBJECTIVES: To retrospectively compare frequency of contact lens (CL) complications in soft CL users of hydrogen peroxide (H2O2) and multipurpose solutions (MPS). METHODS: This was a multicenter, retrospective chart review of CL records from each patient's three most recent eye examinations at academic and private practices. Patients must have used the same solution type for at least 3 years. Univariate analyses were conducted using t tests, and chi-square or Fisher's exact test for categorical measures. RESULTS: There were 1,137 patients included, with 670 (59%) using MPS and 467 (41%) H2O2. In total, 706 (62%) experienced at least one complication; 409 used MPS and 297 used H2O2. There was no difference in the proportion of patients experiencing at least one complication between MPS (61%) and H2O2 (64%) (P=0.38). Multipurpose solutions users were more likely to report discomfort compared with H2O2 users (P=0.04). Presumed microbial keratitis was experienced by 16 MPS and nine H2O2 users (P=0.60). CONCLUSIONS: No significant differences were found in the frequency of CL complications between MPS and H2O2. H2O2 users were less likely to report discomfort and thus switching to a H2O2 system may be an alternative in CL users with discomfort.

Dry Eye Disease in University-based Clinics in Canada: A Retrospective Chart Review.

SIGNIFICANCE: Dry eye disease (DED) imposes a substantial burden on patients, which can lead to significant economic consequences for society. We provide insights into the DED patient population and DED diagnostic/management practices in Canada, which to date have been inadequately addressed in the literature. PURPOSE: The purpose of this study was to describe DED patient demographic/clinical characteristics alongside DED diagnosis/management in university-based optometry clinics in Canada. METHODS: This was a retrospective chart review of nonconcurrent non-Sjögren patients with DED at two university-based optometry clinics in Montreal and Waterloo. Waterloo charts with a diagnosis of DED and all charts from the Montreal dry eye clinic were considered for inclusion. RESULTS: Overall, 200 charts were reviewed. Most patients were female (Montreal, 76%; Waterloo, 72%), and the mean age was 57.2 ± 14.9 years at Montreal and 52.6 ± 20.1 years at Waterloo. Patients commonly reported multiple health conditions (e.g., allergies [Montreal, 44%; Waterloo, 36%]), and high use of systemic nonocular medications was observed (Montreal, 76%; Waterloo, 62%). Clinical signs and symptoms of DED were recorded more often in Montreal patients than in Waterloo patients (e.g., dryness symptoms, 100 vs. 72%; tear breakup time, 100 vs. 60%). Warm compresses (Montreal, 63%; Waterloo, 83%) and artificial tears (Montreal, 94%; Waterloo, 96%) were the most frequently recommended nonmedical treatment and ocular lubricant, respectively. Topical steroids were the most frequently prescribed medications (Montreal, 22%; Waterloo, 21%), with typically three to four different interventions recommended per patient at each clinic. No relationship was found between symptoms and clinical signs or recommended interventions. CONCLUSIONS: This retrospective chart review provided the demographics, clinical characteristics, diagnosis, and management options for DED patients in Canadian university-based optometry clinics. The more comprehensive assessments conducted at Montreal may be beneficial to better monitor the progression of DED and to determine treatment effects over time.

Uptake and Release of Polyvinyl Alcohol from Hydrogel Daily Disposable Contact Lenses.

SIGNIFICANCE: Polyvinyl alcohol is a wetting agent that could reduce the symptoms of dry eye and contact lens discomfort. Currently, only one lens type, nelfilcon A (DAILIES AquaComfort Plus), releases polyvinyl alcohol. The concept of releasing this agent from contact lenses could be applied to other lens materials. PURPOSE: The purpose of this study was to measure the release of polyvinyl alcohol from commercially available hydrogel daily disposable contact lenses using refractive index and iodine-borate methods. METHODS: Etafilcon A, omafilcon A, and nelfilcon A were soaked in phosphate-buffered saline and 0.2% trifluoroacetic acid/acetonitile for 24 hours to remove residual blister pack components. The lenses were then incubated in a 10-mg/mL solution of polyvinyl alcohol for 24 hours. After the incubation period, the lenses were placed in 2 mL of phosphate-buffered saline. At specified time intervals, t = 0.5, 1, 2, 4, 8, 12, and 24 hours, the samples were evaluated using refractive index and an iodine-borate assay. Polyvinyl alcohol uptake was determined by extracting the lenses with methanol for 24 hours. RESULTS: There were no differences in the uptake of polyvinyl alcohol between lens types (P > .05). The release of this wetting agent for all lens types followed a burst-plateau profile after the first 30 minutes (P > .05). Nelfilcon A had a slightly higher release of polyvinyl alcohol (P < .05) than did etafilcon A but was similar to omafilcon A (P > .05). CONCLUSIONS: The results suggest that the contact lenses tested in this study have similar efficiency in delivering polyvinyl alcohol.

Effect of Time on Scleral Lens Settling and Change in Corneal Clearance.

SIGNIFICANCE: With the increase in the use of scleral contact lenses among practitioners, questions regarding lens settling are gradually gaining attention. This is because current studies support the notion that scleral lenses settle back over time. More research is needed to understand the exact cause and the factors that underpin such phenomenon. PURPOSE: The present study aims to assess the effect of time on topographic corneal clearance of three scleral contact lenses of varying sagittal depths. METHODS: Three scleral contact lenses were fitted to 20 subjects with previous diagnosis of keratoconus (n = 18) or pellucid marginal degeneration (n = 2). The fit was based on corneal sagittal height measured with the Visante optical coherence tomographer (OCT) at 15 mm along the horizontal meridian. To select an appropriate lens from the diagnostic lens set, values of 325 µm (lens 1), 375 µm (lens 2), and 425 µm (lens 3) were randomly added in sequence to the corneal sagittal height. Subjects wore each lens for 1 hour. Corneal clearance was measured at 10-minute intervals for 1 hour using a custom ultra-long OCT. To assess change in clearance, central point and two mid-peripheral points (+3 mm and -3 mm) along an 8-mm chord were measured by taking differences at each time point up to 1 hour. Measurements were repeated for the two other lenses. RESULTS: Mean central corneal clearance loss for all three lenses was 33.83 ± 48.40 µm. This was 26 ± 27 µm (13 ± 14 µm, +3 mm; 34 ± 37 µm, -3 mm), lens 1; 35 ± 59 µm (38 ± 61 µm, +3 mm; 52 ± 69 µm, -3 mm), lens 2; and 41 ± 54 µm (33 ± 26 µm, +3 mm; 52 ± 48 µm, -3 mm), lens 3, respectively. There was no significant difference (P = 0.06) at central and other locations for lens 1 (location and over time). There were significant differences for both lenses 2 and 3 (P < .001, P = .01, respectively) for all three locations and over time. CONCLUSIONS: There is a likelihood of clearance loss after 1 hour of lens wear. This varies between subjects, initial lens-fit relationship, and over time.

Lipid Deposition on Contact Lenses when Using Contemporary Care Solutions.

SIGNIFICANCE: There remains only a small amount of data from human studies demonstrating the effect of contact lens/lens care solution combinations on the deposition of lipids. Therefore, information on the degree to which modern materials deposit lipids when used with contemporary care solutions would be valuable. PURPOSE: The present study aims to determine the effect of lens care system combinations on levels of total lipid, cholesterol, and cholesteryl esters extracted from three different contact lenses (CLs) when used with four contemporary care systems. METHODS: Experienced CL wearers were recruited to participate in this study. Combinations of three CLs (etafilcon A [ETA], galyfilcon A [GALY], and senofilcon A [SENO]) and four CL care solutions (Biotrue, ClearCare, OPTI-FREE PureMoist, and RevitaLens Ocutec) were investigated. A total of 791 CLs were analyzed. Subjects were randomized to one lens type and then used all four lens care solutions in random sequence for 10-14 days before the CLs were collected and analyzed for the amount of cholesterol, cholesteryl esters, and total lipids. RESULTS: The mean range of cholesterol recovered across the different care solutions was 0.34-2.77 µg/lens, 3.48-4.29 µg/lens, and 4.75-6.20 µg/lens for ETA, SENO, and GALY lenses, respectively. Use of OPTI-FREE PureMoist with ETA lenses led to a significantly greater amount of cholesterol being recovered when compared to the use of the other solutions with ETA lenses (P < .05). The mean range of cholesteryl esters recovered across different care solutions was 1.31-2.02 µg/lens, 6.43-7.19 µg/lens, and 7.96-10.13 µg/lens for ETA, SENO, and GALY lenses, respectively. There were no differences in the amount of cholesteryl esters and total lipids extracted for a given lens type when used with any of the four care solutions (P > .05). CONCLUSIONS: This study did not demonstrate conclusively that any of the solution/CL combinations were superior to any of the other combinations when the amounts of lipid deposition were compared among the tested lenses.

In Vitro Effect of Lysozyme on Albumin Deposition to Hydrogel Contact Lens Materials.

SIGNIFICANCE: Albumin deposition on contact lenses could be detrimental to contact lens (CL) wear because this may increase the risk of bacterial binding and reduce comfort. Lysozyme deposition on selected lens materials would reduce albumin deposition on lenses. PURPOSE: This study aims to determine if lysozyme deposition on CLs could act as a barrier against subsequent albumin adsorption, using an in vitro model. METHODS: Six hydrogel CL materials (etafilcon A, polymacon, nelfilcon A, omafilcon A, ocufilcon B, and nesofilcon A) were evaluated. Four CLs of each type were soaked in lysozyme solution for 16 hours at 37°C. Lysozyme-coated lenses were then placed in vials with 1.5 mL of artificial tear solution containing I-labeled albumin for 16 hours at 37°C with shaking. Four uncoated lenses of each type were used as controls. Lenses soaked in radiolabeled albumin were rinsed in a phosphate-buffered saline solution, and radioactive counts were measured directly on lenses using a gamma counter. Albumin uptake on lenses was measured using a calibration curve by plotting radioactive counts versus protein concentration. RESULTS: Results are reported as mean ± SD. Lysozyme-coated etafilcon A lenses exhibited lower levels of deposited albumin than uncoated etafilcon A lenses (58 ± 12 vs. 84 ± 5 ng/lens; P < .05). There were no differences in albumin adsorption between control (uncoated) and lysozyme-coated polymacon (105 ± 10 vs. 110 ± 34 ng/lens), nelfilcon A (51 ± 7 vs. 42 ± 20 ng/lens), omafilcon A (90 ± 20 vs. 80 ± 38 ng/lens), ocufilcon B (87 ± 20 vs. 115 ± 50 ng/lens), and nesofilcon A (170 ± 29 vs. 161 ± 10 ng/lens) lens materials (P > .05). Uncoated nesofilcon A lenses deposited the highest amount of albumin when compared with other uncoated lenses (P < .05). CONCLUSIONS: This study demonstrates that lysozyme deposited onto etafilcon A resists the deposition of albumin, which may potentially be beneficial to CL wearers.

Prolonged Ocular Retention of Mucoadhesive Nanoparticle Eye Drop Formulation Enables Treatment of Eye Diseases Using Significantly Reduced Dosage.

Eye diseases, such as dry eye syndrome, are commonly treated with eye drop formulations. However, eye drop formulations require frequent dosing with high drug concentrations due to poor ocular surface retention, which leads to poor patient compliance and high risks of side effects. We developed a mucoadhesive nanoparticle eye drop delivery platform to prolong the ocular retention of topical drugs, thus enabling treatment of eye diseases using reduced dosage. Using fluorescent imaging on rabbit eyes, we showed ocular retention of the fluorescent dye delivered through these nanoparticles beyond 24 h while free dyes were mostly cleared from the ocular surface within 3 h after administration. Utilizing the prolonged retention of the nanoparticles, we demonstrated effective treatment of experimentally induced dry eye in mice by delivering cyclosporin A (CsA) bound to this delivery system. The once a week dosing of 0.005 to 0.01% CsA in NP eye drop formulation demonstrated both the elimination of the inflammation signs and the recovery of ocular surface goblet cells after a month. Thrice daily administration of RESTASIS on mice only showed elimination without recovering the ocular surface goblet cells. The mucoadhesive nanoparticle eye drop platform demonstrated prolonged ocular surface retention and effective treatment of dry eye conditions with up to 50- to 100-fold reduction in overall dosage of CsA compared to RESTASIS, which may significantly reduce side effects and, by extending the interdosing interval, improve patient compliance.

Pilot Study to Determine the Effect of Lens and Eye Rinsing on Solution-Induced Corneal Staining (SICS).

PURPOSE: The main purpose of this study was to determine whether two interventions (rinsing the lens before lens insertion and rinsing the ocular surface post-lens removal) had any impact on solution-induced corneal staining (SICS). In addition, the presence of hyper-reflective epithelial cells in the presence of SICS was investigated. METHODS: Twenty subjects wore new balafilcon A lenses, which had been soaked overnight in a multipurpose care product containing polyhexamethylene biguanide for 2 hours. The study was conducted across three phases. In phase 1 (investigator and subject masked, randomized eye), one lens was rinsed with nonpreserved saline before lens insertion. In phase 2 (investigator masked, randomized eye), one eye was rinsed with nonpreserved saline after lens removal, before staining assessment. Corneal staining was recorded as the percentage area of the cornea exhibiting superficial punctate staining. In both phases, ocular comfort and presence of specific symptoms were captured. In phase 3, there was no randomized treatment; confocal images of the epithelium were obtained after 2 hours of wear. RESULTS: In phase 1 (lens-rinse), there was no significant difference in staining between the treated and untreated eyes (84 vs. 92%, respectively; p = 0.06). In phase 2 (eye-rinse), there was also no significant difference between the treated and untreated eye (86 vs. 86%, p = 0.92). Most subjects were asymptomatic. In phase 3, images of hyper-reflective cells were captured in 97% of the eyes imaged. CONCLUSIONS: The two rinsing procedures did not affect the level of the SICS response. Hyper-reflective epithelial cells were found to be present in a significant number of eyes exhibiting SICS, and their presence warrants further investigation.

Effect of Short Recovery Periods on Ocular Comfort During Daily Lens Wear.

PURPOSE: To assess the impact of lens-free intervals of varying lengths on end-of-day comfort with soft contact lenses. METHODS: Twenty-five symptomatic lens wearers participated in this randomized, cross-over study involving nine individual 12-hour days: one spectacle (no lens) and eight lens wear days. On each lens wear day, lenses were worn bilaterally in 2-hour intervals, separated by lens-free (recovery) periods of 0, 30, 60, or 80 minutes (repeated throughout the day). For each 2-hour lens wear interval, new lenses were worn. Ocular comfort was rated on a 0 to 100 visual analogue scale (0 = extremely uncomfortable); tear film and ocular parameters were assessed at the beginning and end of each study day. This study involved two different types of silicone hydrogel lenses, and the order of lens type and length of recovery period was randomized. Participants were unaware of the true study purpose and that a new lens pair was used for each lens wear interval. RESULTS: End-of-day comfort on lens wear days was significantly worse than on the spectacle day (p < 0.002). There was no significant effect of the recovery periods on end-of-day comfort (p > 0.05). Although lens wear affected noninvasive tear film break-up time and conjunctival staining, there were no effects of recovery period length on noninvasive tear film break-up time (p > 0.05), tear meniscus height (p > 0.05), corneal staining (p > 0.05), conjunctival staining (p > 0.05), bulbar conjunctival redness (p > 0.05), or limbal redness (p > 0.05). There was no consistent effect of recovery period length on lid margin staining. CONCLUSIONS: Lens-free recovery periods during a 12-hour lens wear day did not positively impact end-of-day comfort in this study. Cumulative lens wear times ranged from 8 to 12 hours, and the results suggest that once the length of lens wear exceeds the usual comfortable wear time, there is no benefit of short recovery periods.

In Vitro Cholesterol Deposition on Daily Disposable Contact Lens Materials.

PURPOSE: The goal of this study was to analyze how various incubation times affect the uptake of cholesterol on silicone hydrogel (SH) and conventional hydrogel (CH) daily disposable (DD) contact lens materials using an in vitro radiochemical detection method. METHODS: Three SH (somofilcon A, delefilcon A, and narafilcon A) and four CH (etafilcon A, nesofilcon A, ocufilcon A, and nelfilcon A) contact lenses were incubated in an artificial tear solution that contained major tear film components and a portion of radioactive C-cholesterol. Lenses (N = 4) were incubated for four incubation times (2, 6, 12, or 16 h) to assess the effects on cholesterol deposition. Subsequent to the incubation, the lenses were extracted using 2:1 chloroform:methanol, and the extracts were analyzed in a beta counter and (in nanograms per lens) extrapolated from standard curves. RESULTS: In general, cholesterol deposited statistically significantly more on SH lenses than CHs (p ≤ 0.033), with the exception of somofilcon A and nesolfilcon A materials (p = 0.067). Within the SH materials, narafilcon A accumulated the largest quantity of cholesterol (p < 0.05) and somofilcon A the lowest (p < 0.05). The uptake of cholesterol ranged from 22.63 ± 2.98 ng/lens to 97.94 ± 4.18 ng/lens for all lens materials. The accumulation of cholesterol was shown to be continuous throughout the 16 h of incubation, without reaching a plateau (p < 0.001). CONCLUSIONS: For the periods that DD lens materials are worn, cholesterol deposits significantly more onto SH contact lenses than CHs. This could have implications for wearers who have higher levels of lipid in their tears that are fitted with SH DD materials.

The Use of Contact Lenses as Biosensors.

: The tear film is a complex multilayer film consisting of various proteins, enzymes, and lipids and can express a number of biomarkers in cases of disease. The development of a contact lens sensor presents a noninvasive alternative for the detection and management of various diseases. Recent work has resulted in the commercialization of a device to monitor intraocular pressure for up to 24 h, and there are extensive efforts underway to develop a contact lens sensor capable of continuous glucose tear film monitoring to manage diabetes. This clinical perspective will highlight the major developments within this field and list some of the major challenges that still need to be addressed.

Release of Fluconazole from Contact Lenses Using a Novel In Vitro Eye Model.

PURPOSE: Rapid drug release followed by a plateau phase is a common observation with drug delivery from contact lenses (CLs) when evaluated in a vial. The aim of this study was to compare the release of fluconazole from seven commercially available daily disposable CLs using a conventional vial-based method with a novel in vitro eye model. METHODS: An eye model was created using two 3-dimensional printed molds, which were filled with polydimethylsiloxane to obtain an inexpensive model that would mimic the eyeball and eyelid. The model was integrated with a microfluidic syringe pump, and the flow-through was collected in a 12-well microliter plate. Four commercial daily disposable conventional hydrogels (nelfilcon A, omafilcon A, etafilcon A, ocufilcon B) and three silicone hydrogels (somofilcon A, narafilcon A, delefilcon A) were evaluated. These CLs were incubated with fluconazole for 24 h. The drug release was measured in a vial containing 4.8 mL of phosphate-buffered saline and in the polydimethylsiloxane eye model with a 4.8-mL tear flow across 24 h. RESULTS: Overall, conventional hydrogel CLs had a higher uptake and release of fluconazole than silicone hydrogel CLs (p < 0.05). A higher drug release was observed in the vial condition compared with the eye model (p < 0.001). In the vial system, the drugs were rapidly released from the CL within the first 2 h, followed by a plateau phase. In contrast, drug release in the eye model under low tear volume was sustained and did not reach a plateau across 24 h (p < 0.05). CONCLUSIONS: Rapid drug release results from using a vial as the release system. Under low tear volume at physiological tear flow, commercial CLs can maintain a sustained drug release profile for up to 24 h. However, eyes with fungal keratitis may have increased tearing, which would significantly accelerate drug release.

Expert Views on Innovative Future Uses for Contact Lenses.

Over the past 10 to 15 years, the availability of new materials and technologies has resulted in revolutionary concepts for contact lenses being proposed that go well beyond correcting vision. These novel uses include their prescribing to deliver topical ocular and systemic drugs, assist with ocular surface disease management, and limit the progression of myopia and novel methods to display visual information. How likely are these concepts to become commercially available, how successful will they be, and what are the potential issues to consider for them to come to market? To answer these questions, a panel of four experts were invited to discuss the benefits and pitfalls of these technologies and what challenges lay ahead of these concepts before their availability. Their responses provide a fascinating insight for the clinician into the likelihood of such revolutionary contact lenses being available in a clinical setting.

Corneal Swelling with Cosmetic etafilcon A Lenses versus No Lens Wear.

PURPOSE: To determine if the use of pigments or adding polyvinyl pyrrolidone during the fabrication of 1-DAY ACUVUE DEFINE (AD) brand contact lenses impacts open-eye corneal swelling compared with no lens wear (NLW). METHODS: A partial double-masked, randomized, bilateral crossover study was conducted in 24 Asian subjects using AD, 1-DAY ACUVUE DEFINE with Lacreon (ADL), NLW, and a control lens with no tint (1-DAY ACUVUE MOIST [AM]). Central corneal thickness was measured before insertion and immediately after removal after 8 ± 1 h of open-eye wear using an optical pachymeter in one eye. Corneal thickness along a 10-mm cord was measured in the contralateral eye using the Visante optical coherence tomographer (OCT). Corneal swelling was tested for noninferiority using a 5% margin. The endothelial bleb response was measured at baseline and 20 min after lens insertion using specular microscopy. Subjective grading of corneal staining and limbal/bulbar hyperemia were also monitored. RESULTS: After 8 ± 1 h of open-eye wear, central corneal swelling across the study lenses with either optical pachymeter or OCT methods was negligible. Peripheral corneal swelling least-square mean differences with OCT were -0.03% (95% confidence interval [95% CI], -0.65 to 0.58%) and -0.26% (95% CI, -0.87 to 0.36%) between AD and ADL and the control lens (AM), respectively, and 1.67% (95% CI, 1.06 to 2.29%) and 1.45% (95% CI, 0.84 to 2.06%) between AD and ADL and NLW, respectively. No endothelial blebs were observed. No clinically significant differences were distinguished between the lenses and NLW for corneal staining and limbal/bulbar hyperemia. CONCLUSIONS: After 8 ± 1 h of open-eye wear, central and peripheral corneal swelling along the horizontal meridian with AD, ADL, AM, and NLW were equivalent. These results confirm that the addition of polyvinyl pyrrolidone or pigments to etafilcon A to obtain a limbal ring design have no impact on corneal swelling or limbal/bulbar hyperemia during normal open-eye wear.

Microbial Contamination of Contact Lens Storage Cases During Daily Wear Use.

PURPOSE: To evaluate contact lens (CL) storage case contamination when used with four different CL care solutions during daily wear of three different CL materials. METHODS: A parallel, prospective, bilateral, randomized clinical trial (n = 38) was conducted. Subjects were randomly assigned to use one of three CL materials (etafilcon A, senofilcon A, or galyfilcon A) on a daily wear basis. Subsequently, each subject randomly used one of four different CL care solutions (Biotrue, OPTI-FREE PureMoist, RevitaLens OcuTec, and CLEAR CARE) for 2 weeks, along with their respective storage cases. After every 2-week period, their storage cases were collected and the right and left wells of each storage case were randomized for two procedures: (1) microbial enumeration by swabbing the storage case surface and (2) evaluation of biofilm formation (multipurpose solution cases only) using a crystal violet staining assay. RESULTS: More than 80% of storage cases were contaminated when used in conjunction with the four CL care solutions, irrespective of the CL material worn. Storage cases maintained with CLEAR CARE (mean Log colony forming units (CFU)/well ± SD, 2.0 ± 1.0) revealed significantly (p < 0.001) greater levels of contamination, compared to those maintained with Biotrue (1.3 ± 0.8) and RevitaLens OcuTec (1.2 ± 0.8). Predominantly, storage cases were contaminated with Gram-positive bacteria (≥80%). There were significant differences (p = 0.013) for the levels of Gram-negative bacteria recovered from the storage cases maintained with different CL care solutions. Storage cases maintained with OPTI-FREE PureMoist (0.526 ± 0.629) showed significantly higher biofilm formation (p = 0.028) compared to those maintained with Biotrue (0.263 ± 0.197). CONCLUSIONS: Levels of contamination ranged from 0 to 6.4 Log CFU/storage case well, which varied significantly (p < 0.001) between different CL care solutions, and storage case contamination was not modulated by CL materials.

Eyelid Margin and Meibomian Gland Characteristics and Symptoms in Lens Wearers.

PURPOSE: To describe the lid margin characteristics of contact lens wearers and relate them to comfort during lens wear. METHODS: Three study sites enrolled habitual contact lens wearers. Subjects completed the Comfort domain of the Contact Lens User Experience (CLUE) questionnaire, and each eye was graded for the presence of mucocutaneous junction (MCJ) displacement, lid margin irregularity, and lid margin vascularity. Examiners counted the number of meibomian gland (MG) orifices in the central centimeter of the lower eyelid and the number of those that showed pouting/plugging and vascular invasion. MG expressibility was graded according to the Shimazaki schema. Subjects were grouped based on presence/absence of each characteristic, total number of orifices (≥5 vs. <5), and expressibility (grade 0 vs. >0). Descriptive statistics are reported. A linear model was used to assess the fixed effect of each characteristic on combined CLUE score and each CLUE statement, if the effect on combined CLUE score showed p < 0.10. RESULTS: The study included 203 subjects (67.5% female) with mean age (±SD) of 30.3 ± 9.6 years. The most commonly observed characteristics were orifice pouting/plugging, compromised MG expressibility, and lid margin vascularity (35.0, 30.3, and 20.4%, respectively). MCJ displacement and MG expressibility had an effect on the combined CLUE score such that individual CLUE statements were analyzed (p = 0.01 and p = 0.06, respectively). MCJ displacement had an effect on comfort upon insertion (p = 0.01), comfort after 5 minutes (p = 0.03), end-of-day comfort (p = 0.01), and ability to maintain ocular moisture (p = 0.030). MG expressibility had a significant effect on general comfort (p = 0.01), comfort throughout the day (p = 0.02), and the ability to maintain ocular moisture (p = 0.02). CONCLUSIONS: MCJ displacement and MG expressibility have an effect on contact lens comfort.