Refitting contact lens dropouts into a modern daily disposable contact lens.

PURPOSE: To determine the number of previous contact lens (CL) wearers who could be comfortably refitted into delefilcon A (DAILIES TOTAL1®) CLs. METHODS: This was a 6-month, three-visit study that recruited subjects who discontinued CLs within the past 2 years because of discomfort or dryness symptoms. Subjects were required to have Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire scores ≤3 and to be able to wear spherical study CLs. Subjects were asked to complete a ±50 comfort visual analogue scale (VAS) at 1 month and a Likert questionnaire after 1 and 6 months of CL wear to understand the subjects' CL experience. RESULTS: All 60 subjects who were fitted with the study CLs were still wearing them after 1 month, while one subject had dropped out by 6 months. Subjects had a median (interquartile range) age of 24.0 (7.0) years (71.7% female). They reported a median VAS score of 44.0 (8.0) units at the 1-month visit, with all reporting a comfortable score. At the 1-month/6-month visits, 98.3%/93.2%, 86.5%/78.0% and 93.2%/91.5% of subjects responded that they were very satisfied or satisfied with their vision, their end-of-day CL comfort and overall CL comfort, respectively. The same subjects responded that they were very likely or likely to continue to wear the study CLs at 1 (89.6%) and 6 months (80.7%) and to recommend the study CLs to a friend at 1 (98.3%) and 6 months (93.2%). CONCLUSIONS: The results suggest that when encountering a CL dropout, a practitioner could educate a patient about trying an alternative CL and consider delefilcon A lenses as an option.

Pilocarpine HCl 1.25% for treatment of presbyopia after laser vision correction: pooled analysis of two phase 3 randomized trials (GEMINI 1 and 2).

PURPOSE: To evaluate the efficacy of topical pilocarpine HCl 1.25% (Pilo) in treating presbyopia in individuals with or without a history of laser vision correction (laser-assisted in situ keratomileusis [LASIK] or photorefractive keratectomy [PRK]). SETTING: Multiple clinical sites. DESIGN: Pooled analysis of 2 identically designed prospective, randomized, vehicle-controlled studies (GEMINI 1 and 2). METHODS: Adults aged 40 to 55 years with presbyopia received once-daily Pilo or vehicle bilaterally for 30 days. Responder rates for ≥3-line improvement in mesopic, high-contrast, binocular distance-corrected near visual acuity (DCNVA) were determined on day 30. RESULTS: Among participants with a history of LASIK/PRK (n = 39 in the Pilo group, n = 41 in the vehicle group), responder rates for ≥3-line improvement in DCNVA on day 30 at hours 0.25, 0.5, 1, 3, 6, 8, and 10, respectively, were 16.7%, 38.9%, 41.7%, 37.8%, 16.2%, 13.9%, and 8.3% with Pilo and 0.0%, 2.6%, 10.5%, 5.1%, 7.7%, 2.6%, and 0.0% with vehicle. Responder rates in the LASIK/PRK subgroup were significantly higher with Pilo than vehicle at hours 0.25 ( P = .0087), 0.5 ( P = .0001), 1 ( P = .0022), and 3 ( P = .0005). In contrast, there were no significant differences in responder rates between Pilo-treated participants with and without LASIK/PRK. Among non-LASIK/PRK participants in the Pilo group (n = 336), responder rates for ≥3-line improvement in DCNVA on day 30 at hours 0.25, 0.5, 1, 3, 6, 8, and 10, respectively, were 16.8%, 32.7%, 39.0%, 28.0%, 17.4%, 12.6%, and 10.5%. CONCLUSIONS: Pilo treatment effectively and similarly improved DCNVA in presbyopes with or without a history of laser vision correction.

Quality of Life in Digital Device Users Who are Treated with Systane Hydration PF.

Purpose: To understand the impact of Systane Hydration PF on dryness symptoms and quality of life in digital device users and to determine if participants prefer either the unit-dose or multi-dose dispensing system of Systane Hydration PF. Materials and Methods: This 2-week, three visit study recruited regular digital device users. Participants were required to score ≤80 on the Impact of Dry Eye on Everyday Life (IDEEL) Quality of Life (QoL) Work domain and between 13 and 32 on the Ocular Surface Disease Index (OSDI) questionnaire. Participants were randomized to either Systane Hydration PF unit-dose or multi-dose for 1 week and switched to the alternative dosing system for the second week. Participations were evaluated by completing the full IDEEL-QoL module and OSDI questionnaire at each visit. Likert surveys were completed to probe dispensing system preferences. Results: Thirty participants with a mean ± SD age of 28.6 ± 12.0 years (70% female) were recruited. Participants had significant improvements in all three IDEEL-QoL domains as well as in OSDI scores (all p < 0.0001). Participants had similar preferences for the two dispensing systems, though they were more likely to indicate that they thought that the multi-dose bottle was more environmentally friendly than the unit-dose vials. Conclusion: Digital device users with dry eye symptoms had meaningful improvements in eye comfort and quality of life scores after being treated with Systane Hydration PF for 2 weeks. Participants did not have a clear dispensing system preference suggesting that the best dispensing system may depend on the patient.

Understanding ocular comfort differences between 0.7% olopatadine and 0.3% pheniramine maleate/0.025% naphazoline hydrochloride eye drops.

CLINICAL RELEVANCE: This study found 0.7% olopatadine (Pataday Once Daily Relief Extra Strength) eye drops to provide better initial comfort than 0.3% pheniramine maleate/0.025% naphazoline hydrochloride (VISINE® Allergy Eye Relief Multi-Action Antihistamine and Redness Reliever) eye drops suggesting that patients may comply better with the Pataday than VISINE. BACKGROUND: To compare the ocular comfort at instillation of Pataday and VISINE allergy eye drops. METHODS: Minimally symptomatic participants were recruited based upon Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire scores (≤3 units); they also had minimal between-eye inter-ocular comfort differences as judged by visual analogue scale scores (VAS; ≤7 units). Baseline comfort was evaluated by eye with a VAS. One drop of Pataday or VISINE was then applied to the right eye with the alternative drop being applied to the left eye. The same VAS evaluated comfort by eye at drop instillation, and then at 30 seconds, 1 minute, and 2 minutes post-instillation. Drop experience was also evaluated with Likert questions. LogMAR visual acuities and bulbar conjunctival redness were evaluated pre- and post-drop instillation. RESULTS: A total of 159 participants were recruited (mean ± SD age = 26.2 ± 7.5). The VAS found that eyes treated with Pataday were significantly more comfortable at instillation than eyes treated with VISINE. Likert questions indicated that participants significantly preferred Pataday drops compared to the VISINE drops at instillation with regards to overall eye comfort, eye stinging, eye burning, and foreign body sensation. There were no between drop differences in visual acuity, though eyes treated with VISINE were less red than eyes treated with Pataday. CONCLUSIONS: Topically applied Pataday drops were more comfortable than VISINE drops.

Development and validation of a new photographic scale to grade lid wiper epitheliopathy.

PURPOSE: Lid wiper epitheliopathy (LWE) is a clinical sign that has been associated with dry eye disease (DED) and contact lens discomfort (CLD). This study describes the development, validation and graders' preference of a new photographic scale for LWE, the Photographic Lid Wiper Epitheliopathy (PLWE) scale. METHODS: The PLWE grading scale was developed using LWE images selected from 57 screened patients (≥18 years of age) with confirmed LWE in both eyes. To validate the PLWE scale, a set including 20 images showing varying degrees of LWE from none to severe was chosen. To assess grading validity and grading reliability, observers were asked to grade the selected images using the PLWE and another commonly used subjective LWE grading protocol (Korb) on two separate sessions. RESULTS: The mean grade (±SD) of all images was not statistically significant different between the PLWE scale (1.55 ± 0.44) and the alternative grading scale (Korb, 1.47 ± 0.54) (ANOVA F1, p > 0.05). The average difference from the mean of all graders was 0.03 ± 0.53 using the PLWE scale and 0.06 ± 0.57 when using the Korb protocol (ANOVA F1, p > 0.05). The Coefficient of Repeatability was 1.04 and 1.12 for the PLWE and Korb scales (p > 0.05). Ninety-five percent of the graders found PLWE easier to use than Korb and the same percentage would consider using the PLWE scale in clinical practice. CONCLUSION: The format of the PLWE is similar to other anterior segment visual grading scales and this study revealed an ease of use preference for employing the PLWE by the graders. The presence of LWE has been associated with DED and CLD, and the addition of this new photographic scale could facilitate clinical judgement and record keeping of LWE in clinical practice.

Determining initial ocular comfort differences between 0.7% olopatadine and 0.035% ketotifen fumarate.

PURPOSE: To compare the ocular comfort at application of topical, over-the-counter, 0.7% olopatadine and 0.035% ketotifen fumarate anti-allergy eye drops. METHODS: This study recruited participants who were minimally symptomatic based upon Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire scores (≤3 units) and who had minimal between-eye inter-ocular comfort differences as judged by visual analog scale scores (VAS; ≤7 units). Baseline comfort was evaluated by eye with a VAS. One drop of 0.7% olopatadine or 0.035% ketotifen fumarate was then applied to the right eye with the alternative drop being immediately applied to the left eye. Participants were next evaluated with the same comfort VAS by eye at drop application, and then at 30 s, 1 min, and 2 min post-application. LogMAR visual acuities and bulbar conjunctival redness were evaluated pre- and post-drop application to judge initial changes. RESULTS: This study enrolled 159 participants who had a mean ± SD age of 26.3 ± 7.7 years, and 78.6% of the participants were female. The VAS found that the 0.7% olopatadine drop was more comfortable than the 0.035% ketotifen fumarate drop at all time-points. There were no between-eye differences in LogMAR visual acuities, yet bulbar redness was significantly less in 0.7% olopatadine treated eyes compared 0.035% ketotifen fumarate treated eyes. CONCLUSION: This study found that topically applied 0.7% olopatadine drops were initially more comfortable than 0.035% ketotifen fumarate drops.

Tribology and the Ocular Surface.

Introduction: Tribology is known as the science of friction, lubrication and the determination of what occurs when two surfaces slide against one another. The required partners in this science are a minimum of two surfaces and relative motion. Tribology could be a key factor in dissecting the issues that surround and confound dry eye in patients as well as contact lens discomfort and intolerance. Specifically, it is this issue that is a potential causative underlying factor that could lead to conditions like lid wiper epitheliopathy (LWE). Methods: Peer-reviewed literature was reviewed as It pertains to ocular tribology and the application to the ocular anatomy. A PubMed review was performed using the keywords: tribology, friction, lid wiper epitheliopathy, contact lens, and dry eye. All manuscripts were reviewed for mentions of tribology and friction. The exact same process was performed with The Association for Research in Vision and Ophthalmology (ARVO) abstracts. Results: In relation to the ocular surface, tribology describes the mechanical interactions between the upper and lower lid wipers and the globe. The Stribeck curve can be applied, as the sliding partners are separated by a complex, lubricating tear film. The surface brush anatomy at the eye to eyelid juncture reduces friction and alters the Stribeck curve in favor of the hydrodynamic regime, allowing for high velocity movement with minimal wear. Changes to the tear film or the introduction of a contact lens can displace the Stribeck curve, increase friction, and induce wear thus leading to patient symptomology. Conclusion: Further studies may provide new insight into contact lens discomfort and ocular surface disease, including LWE; however, adaptation of tribology work performed in vitro to in vivo patient care is challenging.

Natural course of lid wiper epitheliopathy (LWE) in symptomatic contact lens wearers.

PURPOSE: To establish the time course of lid wiper epitheliopathy (LWE) in established CL wearers after a single day (6-10 h) of daily disposable contact lens (CL) wear, the following day post-CL removal and 1-week after CL discontinuation. METHODS: Twenty-one symptomatic (CLDEQ-8 score ≥ 12) habitual wearers of MyDay® silicone hydrogel daily disposable were included. LWE staining was assessed prior to CL wear (Visit 1, V1) using semi-automated analysis after instillation of two drops of 1 % lissamine green (10 µL) that were applied to the superior bulbar conjunctiva. LWE measurements were repeated after 6-10 h of continuous CL wear (Visit 2, V2), post-CL removal the following day (Visit 3, V3) and after 1-week CL discontinuation (Visit 4, V4). At each visit, ocular symptoms were evaluated using the SPEED-8 questionnaire and set of 0-100 visual analogue scales (VAS). RESULTS: LWE showed no significant changes after 6-10 h of continuous CL wear (p = 0.536), post-CL removal the following day (p = 0.677) or following 1-week of CL discontinuation (p = 0.478). Analysis revealed a significant improvement in symptomatology between V1 and V2 (SPEED-8, p < 0.01) and also improvements in the 0-100 VAS scores between V2 and V4 for average daily dryness (p < 0.01), end-of-day dryness (p < 0.01) and frequency of end-of-day dryness (p < 0.05). CONCLUSION: The present data suggest that the etiology of LWE is multifactorial and the sole intervention of temporarily discontinuing CL wear does not lead to resolution of these clinical signs.

Application of systane complete for the treatment of contact lens discomfort.

PURPOSE: To understand the safety of treating contact lens (CL) discomfort with a new artificial tear when it is directly applied to a CL-wearing eye. METHODS: This was a two-week, two-visit, double-masked study that randomized participants with CL discomfort to use Systane Complete (artificial tear), Sensitive Eyes (rewetting drop), or no treatment. Drops were applied before, twice during, and after CL use each day. Corneal staining served as the primary safety metric. Conjunctival staining, tear break-up time, Schirmer's test, CL comfort (Contact Lens Dry Eye Questionnaire-8 [CLDEQ-8]), and dry eye symptoms (Standardized Patient Evaluation of Eye Dryness [SPEED]) were also evaluated. RESULTS: This study recruited 73 participants with a mean age of 30.3 ± 11.5 years; 18 % of the participants were male. There were no significant changes in ocular surface signs from baseline or between the artificial tear and rewetting drop groups after two weeks (p ≥ 0.05). Participants in the artificial tear and rewetting drop groups had significant improvements in CLDEQ-8 scores after two weeks of treatment compared with baseline (p < 0.0001), though scores for this test were not significantly different between these groups after two weeks (p = 0.94). CLDEQ-8 scores were significantly better in the artificial tear and rewetting drop groups compared with no treatment after two weeks (p < 0.0001). CONCLUSIONS: Both drops were found to be safe for use with CLs while also significantly improving ocular symptoms compared to no treatment after two weeks of use.

Optimal methodology for lid wiper epitheliopathy identification.

PURPOSE: Lid wiper epitheliopathy (LWE) is a clinical sign that has been associated with dry eye disease. This study used a semi-automated method to identify the effect of drop instillation and post-dye viewing time on the absorption of lissamine green (LG) and sodium fluorescein (NaFl) on the upper eyelid in order to ascertain the optimal identification for LWE assessment. METHODS: In 37 participants with LWE, 1-drop of 1% LG (10 µL) was applied to the superior bulbar conjunctiva in the right eye, and photographs of the lid margin were taken 1, 3, and 5 min after instillation. Measurements were repeated in the same eye following instillations of 2-drops of 1% LG. The same procedures were followed for application of 2% NaFl (2 µL) to the left eye. Staining area was determined using software to detect and measure dye-stained images. Analysis used a linear mixed model with fixed effects of time, number of drops and their interaction. RESULTS: For LG, multivariate analysis showed that time of drop instillation was significant (p = 0.0091) as was the area of staining in the 2-drop versus 1-drop condition (p < 0.0001). For NaFl, there was a significant effect of time (p < 0.0001), drops (p < 0.0001), and a time/drops interaction (p < 0.0134), suggesting that both time and number of drops are important. CONCLUSION: A single drop of dye is insufficient to reveal the full extent of LWE staining. A 2-drop instillation is recommended and observation is recommended between 1 and 5 min (LG) and between 3 and 5 min (NaFl).

Evaluation of Systane Complete for the Treatment of Contact Lens Discomfort.

PURPOSE: To understand if a new artificial tear, which is indicated for the treatment of both evaporative and aqueous deficient dry eye, is able to safely alleviate contact lens discomfort (CLD) in symptomatic soft contact lens (CL) wearers. METHODS: This registered, investigator-masked, two-week, randomized clinical trial recruited adult subjects with symptomatic Contact Lens Dry Eye Questionanire-8 (CLDEQ-8 scores ≥ 12) scores. Subjects were randomized to use artificial tears (Systane Complete) before and after CL use or no treatment. Clinical signs (visual acuity, tear breakup time, corneal staining, Schirmer's test I, and meibum quality and expression) and symptoms (CLDEQ-8, Standardized Patient Evaluation of Eye Dryness (SPEED), self-reported) were evaluated at baseline and two weeks. RESULTS: This study recruited 22 subjects who were randomized to artificial tears and 24 subjects who were randomized to no treatment. Subjects in the artificial tears group had significantly better CLDEQ-8 scores (12.86 ± 6.40 vs. 17.92 ± 5.30; p = 0.006) but not SPEED scores (7.55 ± 4.31 vs. 9.29 ± 4.14; p = 0.17) at two weeks compared to the no treatment group. No significant between group differences were noted for any clinical signs at two weeks (all p > 0.29). No subject in either group reported any adverse events during the study. CONCLUSIONS: Systane Complete was found to safely and significantly improve CL comfort in symptomatic CL wearers. Additional work is needed to better understand the mechanism(s) leading to improved comfort since tested clinical signs were unchanged.