Real-world treatment patterns of OTX-101 ophthalmic solution, cyclosporine ophthalmic emulsion, and lifitegrast ophthalmic solution in patients with dry eye disease: a retrospective analysis.

BACKGROUND: Dry eye disease (DED) is a disorder characterized by loss of tear film homeostasis that causes ocular surface inflammation and damage. The incidence of DED increases with age. Cyclosporine ophthalmic solution 0.09% (CEQUA®; OTX-101), cyclosporine ophthalmic emulsion 0.05% (Restasis®; CsA), and lifitegrast ophthalmic solution 5% (Xiidra®; LFT) are anti-inflammatory agents indicated for DED. This analysis compared treatment patterns in patients with DED receiving OTX-101, CsA, or LFT. METHODS: This real-world, retrospective, longitudinal cohort study utilized Symphony Health Integrated Dataverse claims from July 2019 to June 2021. The dataset included all patients with OTX-101 claims and patients with CsA or LFT claims randomly selected 2:1 to OTX-101. Patients were sorted into 3 cohorts based on index treatment. Index date was that of first treatment claim, and follow-up period was from index date to end of clinical activity or data availability. Time to treatment discontinuation (TTD), probability of discontinuation, and treatment persistence were assessed for OTX-101 vs. CsA, then OTX-101 vs. LFT. Subgroup analysis was performed based on age and prior DED treatment. Kaplan-Meier analysis and log-rank test were used to examine TTD. A logistic model evaluated association between index treatment and discontinuation. Unadjusted and adjusted odds ratios, 95% confidence intervals, and P-values were reported, with statistically significant associations based on P-values < 0.05. RESULTS: Overall, 7102 patients (OTX-101 n = 1846; CsA n = 2248; LFT n = 3008) were eligible. Median TTD was 354 days for patients receiving OTX-101 vs. 241 days for CsA and 269 days for LFT. Log-rank test indicated TTD was significantly longer for patients on OTX-101 vs. CsA (P = 0.033). Patients on CsA were 35% more likely to discontinue treatment than patients on OTX-101; OTX-101 and LFT groups had similar discontinuation rates. After 360 days, 49.8% of patients receiving OTX-101 remained on treatment vs. 39.4% of patients on CsA (P = 0.036) and 44.0% of patients on LFT (P = 0.854). CONCLUSIONS: Patients receiving OTX-101 remained on treatment significantly longer and were significantly less likely to discontinue treatment than patients on CsA. Older patients remained on OTX-101 significantly longer than CsA. These findings highlight treatment pattern differences in patients with DED receiving these anti-inflammatory agents.

The Prevalence and Severity of Acquired Blepharoptosis in US Eye Care Clinic Patients and Their Receptivity to Treatment.

Purpose: To assess the presence and severity of acquired blepharoptosis (ptosis) among patients visiting an eye care clinic and the receptivity of eligible patients to pharmacologic treatment with oxymetazoline 0.1% ophthalmic solution. Patients and Methods: Patients aged 50 years or older who had a scheduled clinic appointment for any reason (eg, dry eye, cataract surgery consultation) were asked to respond to written questions about lid position and select whether their upper lid position most closely matched one of 4 images shown to them corresponding to no, mild, moderate, or severe ptosis. Patients selecting any of the mild, moderate, or severe ptosis were offered treatment with oxymetazoline 0.1% ophthalmic solution, barring any medical contraindications. The outcome measures were the proportion of patients with each self-reported lid position level (none to severe ptosis), the proportion of patients with asymmetric ptosis, and the proportion of patients willing to accept the treatment. Results: Data for 188 eyes of 94 patients were analyzed. Overall, 73.4% of patients had ptosis in at least one eye, and 25.5% had an asymmetric upper eyelid presentation. The proportions of patients with self-reported mild, moderate, or severe ptosis in at least one eye were 41.5%, 25.5%, and 6.4%, respectively. Among those patients eligible for treatment, 19.7% were willing to accept the treatment. Conclusion: Based on patients' self-assessment of lid position, this study suggests a higher prevalence of ptosis than reported previously. Evaluation of the eyelids should be a standard part of the comprehensive eye examination.

Early Real-World Patient and Staff Experience with an Intracanalicular Dexamethasone Insert.

Purpose: To evaluate both the early experience of real-world patients treated with dexamethasone ophthalmic insert (0.4 mg; DEXTENZA®), hereafter referred to as DEX, after cataract surgery as well as staff/practice integration of DEX relative to eyedrops. Patients and Methods: This was a cross-sectional survey study of 23 cataract practices in the United States. Respondents were patients and practice staff who had experience with DEX following cataract surgery. Both patients and practice staff completed an online survey. Descriptive statistics summarized the survey responses to portray the experience of the respondents. Results: Surveys were completed by 62 patients and 19 practice staff. Almost all patients (93%) were satisfied or extremely satisfied with DEX. Patients highly preferred DEX (93%) to topical steroid drops (7%) based on past experiences with topical steroid drops. Most practice staff (95%) were satisfied or highly satisfied with DEX, reporting a 45% reduction in time spent educating patients on postoperative drop use and a 46% decrease in time spent addressing calls from pharmacies regarding postoperative medications. Conclusion: Incorporating the DEX insert into clinical practice in cataract surgery practices can improve patient adherence, while potentially providing significant savings to practices in terms of time spent educating patients and responding to patient and pharmacy call-backs.

Preoperative Treatment of Meibomian Gland Dysfunction with a Vectored Thermal Pulsation System Prior to Extended Depth of Focus IOL Implantation.

INTRODUCTION: Patients implanted with a range-of-vision intraocular lens (IOL) (multifocal or extended depth of focus, EDOF) may be more susceptible to visual disturbances from poor tear film quality, and prophylactic treatment of meibomian gland dysfunction (MGD) has been recommended. The purpose was to evaluate whether vectored thermal pulsation (LipiFlow™) treatment prior to cataract surgery with a range-of-vision IOL safely improves postoperative outcomes. METHODS: This is a prospective, randomized, open-label, crossover, multicenter study of patients with mild-to-moderate MGD and cataract. The test group underwent LipiFlow treatment prior to cataract surgery and implantation of an EDOF IOL, while the control group did not. Both groups were evaluated 3 months postoperatively, after which the control group received LipiFlow treatment (crossover). The control group was re-evaluated 4 months postoperatively. RESULTS: A total of 121 subjects were randomized, with 117 eyes in the test group and 115 eyes in the control group. At 3 months after surgery, the test group had a significantly greater improvement from baseline in total meibomian gland score compared with the control group (P = 0.046). At 1 month after surgery, the test group had a significant decrease in corneal (P = 0.04) and conjunctival (P = 0.002) staining compared to the control group. At 3 months after surgery, the test group had significantly lower incidence of being bothered by halos compared with the control group (P = 0.019). The control group had a significantly lower incidence of being bothered by multiple or double vision compared with the test group (P = 0.016). After crossover, patients had significant improvement in vision (P = 0.03) and total meibomian gland score (P < 0.0001). No safety concerns or relevant safety findings were uncovered. CONCLUSION: Presurgical LipiFlow treatment of patients implanted with range-of-vision IOLs improved meibomian gland function and postoperative ocular surface health. This supports guidelines recommending proactive diagnosis and management of MGD in patients with cataracts to improve patient experience. TRIAL REGISTRATION: The study was registered on www. CLINICALTRIALS: gov (NCT03708367).

Interpersonal Communication in Eye Care: An Analysis of Potential Impacts on Cataract Surgery Candidates' Expectations and Behaviors.

Purpose: To identify cataract surgery candidates' knowledge, beliefs, desires and emotions as they relate to cataract surgery generally as well as to their behavioral intent to adhere to a doctor-recommended pre-surgical ocular surface prep routine designed to improve refractive outcomes and prevent surgical complications. Methods: This national, noninterventional, cross-sectional, mixed methods survey included 278 US adults ages 65 and older with no history of cataract surgery in either eye. Results: Only 20% of participants said they want to have cataract surgery, and even fewer (8%) said they wish they could have cataract surgery right away. Fear was the predominant emotion in one out of every three respondents and was correlated with intention to delay having cataract surgery for as long as possible (r = 0.44). Fewer than 2% of participants said their doctors recommended home-health strategies to combat the risks of ocular surface disease preoperatively. However, most say they would use a pre-surgical prep kit if their doctor gave them one (87%), asked them to buy one (83%), or directed them to obtain one online (71%). Conclusion: These findings negate the popular assumption that patients are in a hurry to have their cataract surgery right away and, therefore, may resist physician recommendations to address ocular surface disease pre-operatively.

Personalized Management of Dry Eye Disease: Beyond Artificial Tears.

Dry eye disease (DED) is a multifactorial disease of the ocular surface that may be accompanied by discomfort and visual disturbances to a level that reduces quality of life. Artificial tears are a common first-line therapy for DED that aim to supplement the tear film but do not address the underlying causes of DED. Because of the complexity and variability of the disease, personalized treatment beyond artificial tears is important for successful management. This review describes artificial tears and the current knowledge in the personalized approach to the management of DED. There is evidence that artificial tears can reduce symptoms and signs of DED; however, a proportion of patients have been found to show limited or no improvement with artificial tears. Furthermore, the effectiveness of artificial tears may depend on patient compliance and type of artificial tear product used. Personalized management of DED with other treatments involves identifying features of the disease, including the subtype of DED, the presence of inflammation, and the coexistence of external and behavioral contributing factors. Various measures exist to characterize DED, including assessments of the tear film lipid layer, the meibomian glands, tear volume, tear osmolarity, and matrix metalloproteinase 9 levels. Because individuals can show variable features, the most prominent clinical findings, comorbidities, triggering events, and treatment history should be considered to determine the best treatment choices for patients.

OC-01 (Varenicline Solution) Nasal Spray Demonstrates Consistency of Effect Regardless of Age, Race, Ethnicity, and Artificial Tear Use.

Purpose: To evaluate OC-01 [varenicline solution nasal spray (VNS)] tear production and symptom outcomes in patients with dry eye disease by age, gender, race, ethnicity, and artificial tear use status. Patients and Methods: Adults ≥22 years of age diagnosed with dry eye disease, with Ocular Surface Disease Index score ≥23, corneal fluorescein staining score ≥2 in ≥1 region or ≥4 for all regions, and baseline Schirmer Test Score (STS) ≤10 mm, with no restrictions on eye dryness score (EDS). Efficacy was assessed using integrated data from ONSET-1 and ONSET-2 [vehicle control (VC), n=294; OC-01 VNS 0.03 mg, n=308]. Subgroups included age (≤55, 56-65, >65 years), gender (male, female), race (White, Black or African American), ethnicity (Hispanic or Latino, Not Hispanic or Latino), and artificial tear use (yes, no). Analysis of covariance models, with the covariates treatment, study site, and baseline severity measures, were used to calculate treatment-VC differences. Consistency of effect among subgroups was evaluated by conducting interaction tests. Results: Consistency of treatment effect across subgroups was observed for all endpoints, with P value for all treatment-subgroup interaction terms >0.05. For % of patients with ≥10mm improvement in STS and least squares (LS) mean change from baseline in STS and EDS, there was improvement in tear production across demographic group categories. Artificial tear use did not change STS or EDS outcomes with OC-01 VNS. Conclusion: OC-01 VNS improved tear production and patient-reported symptom outcomes across a broad range of patients by age, gender, race, and ethnicity, and regardless of artificial tear use status at baseline. OC-01 VNS demonstrated a consistent benefit across an extensive range of patients with dry eye disease.

Early Real-World Physician Experience with an Intracanalicular Dexamethasone Insert.

Purpose: To describe the early real-world experience of physicians with an intracanalicular dexamethasone insert (DEX) in patients undergoing cataract surgery and to capture the clinical impact of adopting this therapy. Patients and Methods: 23 United States sites including Ambulatory Surgical Center Setting (ASC) and Outpatient Clinical settings. Respondents were physicians who had early experience with DEX in cataract surgery patients. This was a Phase 4 experiential cross-sectional survey study comprised of 3 sequential online physician surveys. Descriptive statistics summarized the surveys' responses to determine the early impressions of the respondents. Results: Forty-two physicians completed surveys. On average, physicians reported feeling comfortable administering DEX after placing 3 inserts (mean 2.7; standard deviation 1.9). Most physicians (92%) were satisfied with DEX, and all physicians (100%) reported that DEX improved patient compliance. Most physicians (62.5%) indicated they would highly prefer DEX over traditional steroid eyedrops for the management of post-surgical inflammation and pain. Conclusion: The surveys exploring the early use of DEX suggest that DEX is a clinically effective treatment with a rapid initial learning curve and integrates well into clinical use. Physicians had a very positive early experience with DEX, including comfort with insertion and satisfaction. DEX shows promise as a primary treatment choice of physicians for ocular inflammation and pain following cataract surgery by offering patients a hands-free innovative therapy that delivers a preservative-free steroid to the ocular surface over approximately 30 days.

Dry Eye Treatment with Topical Cyclosporine 0.1% in Chondroitin Sulfate Ophthalmic Emulsion.

PURPOSE: To evaluate the efficacy of topical cyclosporine 0.1% in chondroitin sulfate emulsion for the treatment of dry eye. METHODS: This retrospective multicenter study included 100 eyes of 50 dry eye patients aged ≥18 years, with preoperative ocular surface disease index (OSDI) score >12 or corneal staining grade >1 (in either eye) who underwent dry eye treatment with topical cyclosporine 0.1% in chondroitin sulfate emulsion (Klarity-C, ImprimisRx) for 3 months. Postoperative evaluation included comparison of the changes in OSDI score and corneal staining grade after 3 months of treatment from baseline. RESULTS: From baseline to 3 months, a statistically significant improvement in mean OSDI scores (38.19 vs 24.18, p <0.001) as well as mean corneal staining grade (3.62 vs 2.20, p <0.001) was observed. The proportion of subjects with severe dry eye decreased from 62% to 20% and more than one-third (34%) of patients were in the normal OSDI range. The percentage of eyes with corneal staining grade of 2 or 3 decreased from 21% (baseline) to 8% at 3 months; 50% of the eyes had corneal staining grade of 0. The treatment was found to be safe with no adverse events observed in the study. CONCLUSION: Dry eye treatment with twice daily cyclosporine 0.1% in chondroitin sulfate emulsion was found to be safe and effective in reducing signs and symptoms of dry eye.

Impact of dexamethasone intraocular suspension 9% on intraocular pressure after routine cataract surgery: post hoc analysis.

PURPOSE: To characterize intraocular pressure (IOP) response after treatment with dexamethasone intraocular suspension 9% vs placebo (vehicle) injection or topical prednisolone acetate 1% and to identify factors associated with increased IOP after cataract surgery. SETTING: Data were pooled from two multicenter phase 3 clinical trials of patients undergoing routine cataract surgery. DESIGN: Randomized, double-blind study and open-label study. METHODS: Subjects were randomized to treatment with dexamethasone intraocular suspension or placebo in the double-blind study 1 and to dexamethasone intraocular suspension or topical prednisolone acetate in the open-label study 2. Subjects who experienced 10 mm Hg or greater, 15 mm Hg or greater, or 20 mm Hg or greater postoperative IOP increase from baseline were stratified by baseline IOP. Univariate and multivariate logistic regression models of patient variables were applied to identify independent risk factors predictive of IOP elevation of 10 mm Hg or greater or 15 mm Hg or greater. RESULTS: The study comprised 414 subjects. Dexamethasone intraocular suspension was associated with a slightly higher mean IOP at the first postoperative visit vs prednisolone (P < .05); however, mean IOP was not statistically different between the 2 groups by postoperative day 8 (P = .5006) or thereafter. Univariate analysis showed that both prednisolone and dexamethasone intraocular suspension increased risk for postoperative IOP elevation compared with placebo; however, there was no statistically significant increased risk with dexamethasone intraocular suspension vs prednisolone. Aside from antiinflammatory treatment, risk factors for postoperative IOP elevation by univariate and multivariate analyses were higher baseline IOP, high myopia, and, when defining IOP increase as 15 mm Hg or greater from baseline, male sex. CONCLUSIONS: Dexamethasone intraocular suspension was associated with IOP elevation patterns comparable with topical prednisolone. High myopia, higher baseline IOP, and male sex were significant predictors of postoperative IOP elevation in this cohort.

Impact of Thermal Pulsation Treatment on Astigmatism Management and Outcomes in Meibomian Gland Dysfunction Patients Undergoing Cataract Surgery.

PURPOSE: This study aimed to assess the effects of thermal pulsation system (TPS) treatment on astigmatism management in meibomian gland dysfunction (MGD) patients undergoing cataract surgery. PATIENTS AND METHODS: This single-center pilot study included 25 eyes of 23 patients who had visually significant cataract and concomitant MGD-associated dry eye in at least 1 eye and were willing to undergo TPS treatment and wait for at least 6 weeks for tear film stabilization prior to cataract surgery. Post-TPS keratometric readings were used for presurgical planning, and the actual postoperative residual refractive astigmatism (RRA) was recorded. Pre-TPS keratometry was used to mathematically simulate the RRA that would have been obtained from the lens choice and astigmatism management without TPS treatment. RESULTS: Following TPS treatment, the magnitude of astigmatism increased in 52% of eyes, decreased in 24%, and remained unchanged in 24%. Correspondingly, astigmatism treatment modality changed in 68% of eyes after tear film stabilization with TPS treatment. The type of astigmatism management increased (ie, shifted from no treatment to LRI or LRI to toric IOL) in 25% of eyes and decreased in 8%. Actual RRA ≤0.5 D was achieved in 76% of eyes, compared to simulated RRA ≤0.5 D in 40% of eyes (p=0.004). CONCLUSION: Stabilization of the tear film with TPS treatment resulted in less RRA than if pre-TPS keratometric readings had been used to determine the astigmatism management method and toric IOL power and axis.

The Prevalence and Incidence of Dry Eye Disease Among Patients Using Continuous Positive Airway Pressure or Other Nasal Mask Therapy Devices to Treat Sleep Apnea.

INTRODUCTION: Dry eye disease (DED) prevalence is estimated at 9.3% of the US adult population, although diagnosed rate is much lower. This study examined real-world incidence rates (IR) and prevalence rates (PR) of DED in adults using continuous positive airway pressure (CPAP) or nasal mask therapy (NMT) devices to treat sleep apnea. METHODS: Using IBM MarketScan Commercial and Medicare Supplemental claims databases, this study identified adults with ≥1 claim of CPAP or other NMT device between January 1, 2014 and June 30, 2018, ≥1 diagnosis of sleep apnea during a 12-month pre-index period, and continuous benefit enrollment ≥12 pre- and post-index date. The date of the first CPAP or NMT device claim was considered the index date. Descriptive analyses included PR, IR, and IR per 100-person years (100PY) for the overall population and subgroups including age, sex, and baseline comorbidities. RESULTS: The 1-, 2-, and 3-year PR of DED was 6.2%, 10.0%, and 13.0%, while the IR of DED was 4.0%, 7.3%, and 10.3%, respectively. Females had a higher IR of DED compared to males: 5.8%, 10.8%, and 15.1% vs 3.0%, 5.4%, and 7.9%, respectively. DED increased with age with a 1-, 2-, and 3-year PR for patients aged 18-24 years of 2.2%, 3.4%, and 5.0% vs 17.6%, 25.8%, and 32.1% in patients aged ≥75, respectively. Overall, IR per 100PY of DED was 3.68, higher for females than males (5.51 vs 2.73). PR and IR of DED were high among patients with comorbid inflammatory or metabolic conditions. CONCLUSION: The PR and IR of DED in CPAP or NMT users were higher than the reported prevalence of DED in the general population. CPAP/NMT users who were female, older, or had comorbid inflammatory or metabolic conditions may experience a higher incidence and prevalence of DED.

Novel Extranasal Tear Stimulation: Pivotal Study Results.

Purpose: To evaluate the efficacy and safety of iTEAR, a novel, portable, sonic external neuromodulation device, for the treatment of dry eye disease (DED). Methods: This was a multicenter, open-label, single-arm clinical trial that included adult patients with DED with a Schirmer score of ≤10 mm in at least one eye. Enrolled subjects were instructed to apply the study device at least twice per day for 30 seconds bilaterally to the external nasal nerve. After the initial baseline visit, patients were followed up at days 3, 14, 30, 90, and 180. The primary efficacy endpoint was the Schirmer index (change from unstimulated to stimulated tear production as measured by the Schirmer test) at day 30. The major secondary endpoint was the change in symptoms of DED at day 30 evaluated using the Ocular Surface Disease Index (OSDI). Results: A total of 101 subjects evaluated at day 30 had a mean Schirmer index of 9.4 mm (95% confidence interval [CI], 7.4-11.3), and the baseline OSDI improved by an average of 14.4 (95% CI, 11.1-17.7). Both endpoints were highly statistically and clinically significant at all time points. There were two mild unanticipated adverse events definitely related to the device. Conclusions: The safety and efficacy of the iTEAR device observed in this study support its indication for treating DED. Translational Relevance: Neurostimulation has the potential to improve signs and symptoms of DED.

Dry Eye Disease: Consideration for Women's Health.

Dry eye disease (DED) is a multifactorial disorder of the ocular surface and tear homeostasis that can result in discomfort, pain, and visual disturbance. Untreated, DED can become chronic, progressive, and significantly affect an individual's quality of life. Women are disproportionately affected by DED, are diagnosed at a younger age, and experience more severe symptoms compared with men. DED is associated with a wide range of comorbid conditions; there is a strong association between DED and autoimmune disorders, especially those that affect women at many times the rate of men. Treatment response questionnaires indicate women respond better to a wellness model of treatment for DED than men. Furthermore, women's health care-seeking behaviors provide opportunities for general practitioners, specialists, and women's health centers to help identify women with DED or at risk for DED for referral to an eye care specialist. This review of the prevalence of DED in women, and gender and sex-specific aspects of DED, highlight a significant opportunity for action. Earlier diagnosis and treatment of this common but burdensome condition could significantly improve a woman's quality of life.

Safety of IBI-10090 for inflammation associated with cataract surgery: Phase 3 multicenter study.

PURPOSE: To compare the safety and efficacy of IBI-10090 anterior chamber intracameral dexamethasone drug-delivery suspension (Dexycu) with those of prednisolone acetate 1.0% ophthalmic drops in treating inflammation after cataract surgery. SETTING: Eleven centers in the United States. DESIGN: Prospective randomized open-label multicenter trial. METHODS: Patients were randomized 2:1 to receive a 5 µL injection of 517 µg IBI-10090 in the anterior eye chamber or topical prednisolone 1.0% drops (1 drop 4 times daily for 3 weeks). The postoperative follow-up was 90 days. The primary outcome was safety, evaluated by the incidence and severity of adverse events. Exploratory measures were anterior chamber cell, anterior chamber flare, and anterior chamber cell-flare clearing. RESULTS: One hundred twenty-six IBI-10090 patients and 55 prednisolone patients were included in the safety analysis. Two serious adverse events unrelated to treatment were reported. The decrease in endothelial cell density was not significantly different between groups. The most common adverse events were increased intraocular pressure (11.1%), iritis (6.3%), and systemic (7.9% IBI-10090 group; 10.9% prednisolone group). By 8 days postoperatively, 51.6% of IBI-10090 eyes and 50.9% of prednisolone eyes had anterior chamber cell clearing; more than 98% of eyes had clearing at 90 days. The anterior chamber flare and anterior chamber cell-flare clearing results were similar. Of IBI-10090 patients, 68.7% strongly agreed that not having to use eyedrops was very convenient; 39.2% using prednisolone 1.0% strongly stated they would have preferred dropless therapy. CONCLUSION: The safety and efficacy of IBI-10090 and prednisolone 1.0% were similar, with IBI-10090 preferred over drops.

Characterization of the serological biomarkers associated with Sjögren's syndrome in patients with recalcitrant dry eye disease.

PURPOSE: The purpose was to characterize the biomarkers associated with Sjögren's syndrome (SS) identified in the serological samples of patients with recalcitrant dry eye disease; additionally, the modalities utilized in the treatment of dry eye disease were evaluated for subsets of patients with and without SS. PATIENTS AND METHODS: Data for this retrospective, single-center, pilot study were based on a chart review of 48 sequential patients with recalcitrant dry eye who were evaluated for SS via serological analysis. Data presented include the presence of the autoantibodies identified through the serological biomarker analysis and identification of the concurrent dry eye treatment modalities. RESULTS: Eleven out of 48 patients (23%) tested positive for biomarkers associated with SS. Autoantibodies for salivary protein-1, parotid secretory protein 1, and carbonic anhydrase VI, markers associated with the early development of SS, were detected in 91% (ten out of eleven) of the patients who tested positive for SS, whereas 27% (three out of eleven) of patients tested positive for the traditional SS markers, SS-A and/or SS-B. Common treatment modalities utilized in SS patients included omega-3 supplements (82%), topical cyclosporine (74%), and artificial tear solutions (64%), as compared to omega-3 supplements (80%), hot-mask therapy (77%), and artificial tear solutions (77%), in SS-negative patients. CONCLUSION: Evaluation for salivary protein-1, parotid secretory protein 1, and carbonic anhydrase VI biomarkers allows for identification of a subset of patients with biomarkers associated with SS that may not be identified through the traditional assessments (SS-A/SS-B). Earlier recognition of SS biomarkers allows for a confirmatory diagnosis and appropriate management of this systemic, progressive condition.

Outcomes of intense pulsed light therapy for treatment of evaporative dry eye disease.

OBJECTIVE: To determine the clinical outcomes of intense pulsed light (IPL) therapy for the treatment of evaporative dry eye disease (DED). DESIGN: Multicentre cohort study. PARTICIPANTS: Patients with a diagnosis of meibomian gland dysfunction (MGD) and dry eye presenting to the ophthalmology clinic at either the Duke Eye Center, Durham, NC, or Matossian Eye Associates' private practice in Pennington, NJ, and Doylestown, PA. METHODS: Clinical data were reviewed from 100 patients with diagnosis of MGD and DED who underwent IPL therapy from September 2012 through December 2014 at 1 of 2 centres (Duke Eye Center or Matossian Eye Associates). Demographics, clinical history, examination findings (eyelid and facial vascularity, eyelid margin edema, meibomian gland oil flow, and quality score-all graded on a scale of 0 to 4), tear break up time (TBUT), and ocular surface disease index (OSDI) scoring data were collected from each visit. RESULTS: On average, patients underwent 4 IPL sessions. There was significant decrease in scoring of lid margin edema (mean = -0.3; range -1.5 to 0), facial telangiectasia (mean = -0.7; range -2.5 to 0), lid margin vascularity (mean = -1.2; range -2.5 to 0), meibum viscosity (mean = -1.1; range -3 to 0), and OSDI score (mean = -9.6), all with p < 0.001. There was a significant increase in oil flow score (mean = 0.9, range -0.5 to 2) and TBUT (mean = 3.4 seconds, range -2 to 7), both p < 0.001. No significant changes in intraocular pressure or acuity were noted. There were no cases of adverse ocular effects. CONCLUSIONS: IPL therapy for evaporative DED is a safe procedure. The positive change in objective clinical examination findings and subjective OSDI scoring data suggest that IPL is an effective treatment for patients with evaporative DED.

Effect of Oral Re-esterified Omega-3 Nutritional Supplementation on Dry Eyes.

PURPOSE: To assess the effect of oral re-esterified omega-3 fatty acids on tear osmolarity, matrix metalloproteinase-9 (MMP-9), tear break-up time (TBUT), Ocular Surface Disease Index (OSDI), fluorescein corneal staining, Schirmer score, meibomian gland dysfunction (MGD) stage and omega-3 index in subjects with dry eyes and confirmed MGD. METHODS: This was a multicenter, prospective, interventional, placebo-controlled, double-masked study. Subjects were randomized to receive 4 softgels containing a total of 1680 mg of eicosapentaenoic acid/560 mg of docosahexaenoic acid or a control of 3136 mg of linoleic acid, daily for 12 weeks. Subjects were measured at baseline, week 6, and week 12 for tear osmolarity, TBUT, OSDI, fluorescein corneal staining, and Schirmer test with anesthesia. MMP-9 testing and omega-3 index were done at baseline and at 12 weeks. RESULTS: One hundred five subjects completed the study. They were randomized to omega-3 (n = 54) and control group (n = 51). Statistically significant reduction in tear osmolarity was observed in the omega-3 group versus control group at week 6 (-16.8 ± 2.6 vs. -9.0 ± 2.7 mOsm/L, P = 0.042) and week 12 (-19.4 ± 2.7 vs. -8.3 ± 2.8 mOsm/L, P = 0.004). At 12 weeks, a statistically significant increase in omega-3 index levels (P < 0.001) and TBUT (3.5 ± 0.5 s vs. 1.2 ± 0.5 s, P = 0.002) was also observed. Omega-3 group experienced a significant reduction in MMP-9 positivity versus control group (67.9% vs. 35.0%, P = 0.024) and OSDI scores decreased significantly in omega-3 (-17.0 ± 2.6) versus control group (-5.0 ± 2.7, P = 0.002). CONCLUSIONS: Oral consumption of re-esterified omega-3 fatty acids is associated with statistically significant improvement in tear osmolarity, omega-3 index levels, TBUT, MMP-9, and OSDI symptom scores.

Cataract surgery and methods of wound closure: a review.

Clear corneal incisions are routinely used in cataract surgery, but watertight wound closure may not always be achieved, which can increase the risk for anterior chamber fluid egress or ocular surface fluid ingress. A new US Food and Drug Administration-approved ocular sealant appears to have good efficacy in sealing clear corneal incisions; its use may be indicated when wound integrity is in question.

Effect of tear osmolarity on repeatability of keratometry for cataract surgery planning.

PURPOSE: To evaluate the effects of tear osmolarity on the repeatability of keratometry (K) measurements in patients presenting for cataract surgery. SETTING: Three clinical practices. DESIGN: Observational prospective nonrandomized study. METHODS: Subjects were prospectively recruited based on tear osmolarity (Tearlab Osmolarity System); that is, osmolarity more than 316 mOsm/L in at least 1 eye (hyperosmolar) and osmolarity less than 308 mOsm/L in both eyes (normal). The baseline K value was measured, and a second measurement was taken on the same instrument (IOLMaster) within 3 weeks of the first. Variability in average K, calculated corneal astigmatism using vector analysis, and intraocular lens (IOL) sphere power calculations were compared between groups. RESULTS: The hyperosmolar group (50 subjects) had a statistically significantly higher variability in the average K reading (P = .05) than the normal group (25 subjects) and a statistically significantly higher percentage of eyes with a 1.0 diopter (D) or greater difference in the measured corneal astigmatism (P = .02). A statistically significantly higher percentage of eyes in the hyperosmolar group had an IOL power difference of more than 0.5 D (P = .02). No statistically significant differences were present when the subjects were grouped by self-reported dry eye. CONCLUSIONS: Significantly more variability in average K and anterior corneal astigmatism was observed in the hyperosmolar group, with significant resultant differences in IOL power calculations. Variability was not significantly different when subjects were grouped by self-reported dry eye. Measurement of tear osmolarity at the time of cataract surgery planning can effectively identify patients with a higher likelihood of high unexpected refractive error resulting from inaccurate keratometry. FINANCIAL DISCLOSURE: Drs. Epitropoulos, Matossian, Berdy, and Malhotra received compensation from Tearlab for participating in the study. No author has a financial or proprietary interest in any material or method mentioned.