Short-Term Fit Assessment of a Novel Daily Disposable, Toric, Silicone Hydrogel Contact Lens.

Purpose: The development of new contact lens materials and designs are necessary to minimise patient dropout. A lens material with water surface technology was recently developed to incorporate toric design. The on-eye stability of a toric contact lens is critical to a successful toric lens fitting. In an effort to establish if the new daily disposable verofilcon A toric silicone hydrogel lens provides fast stability for ease of fit, this study assessed the initial and short-term on-eye stability of this new lens. Patients and Methods: Habitual full-time wearers of soft contact lenses, aged 18 or over, were enrolled and fit with the verofilcon A toric lens. Study endpoints included lens settling time, axis orientation at specific time-points within 10 minutes after insertion, lens oscillation with blink, lens movement and centration, and scribe mark visibility. Results: Thirty-nine subjects completed the study; 67% were female and mean age was 34.1 ± 10.8 years (range 18 to 61). The majority of verofilcon A toric lenses (98.7%) settled on average within 60 seconds. Average lens orientation was 3° from six o'clock position within two minutes of insertion. The lenses showed minimal oscillation with blink; 98.7% of the eyes demonstrated ≤5° oscillation with blink. All lenses showed optimal/acceptable lens movement and centration and the scribe mark was reported as easily visible in 96% of eyes. Practitioners reported a 99% first lens fit success rate. Conclusion: The novel verofilcon A toric lens was highly successful with the first lens, had excellent on-eye stability and good fit characteristics. These qualities make this new lens a good option for lens wearers. Furthermore, it fulfills the needs of practitioners who want a toric lens that is easy and predictable to fit.

Phentolamine Eye Drops Reverse Pharmacologically Induced Mydriasis in a Randomized Phase 2b Trial.

SIGNIFICANCE: After a dilated eye examination, many patients experience symptoms of prolonged light sensitivity, blurred vision, and cycloplegia associated with pharmacological mydriasis. Phentolamine mesylate ophthalmic solution (PMOS) may expedite the reversal of mydriasis in patients, potentially facilitating return to functional vision and reducing barriers to obtaining dilated eye examinations. PURPOSE: The protracted reversal time after pharmacologically induced pupil dilation impairs vision. We tested the hypothesis that PMOS rapidly reduces pupil diameter in this acute indication. METHODS: In this double-masked placebo-controlled, randomized, two-arm crossover phase 2b trial, we evaluated the effects of one drop of 1% PMOS applied bilaterally in subjects who had their pupils dilated by one of two common mydriatic agents: 2.5% phenylephrine or 1% tropicamide. End points included change in pupil diameter, percent of subjects returning to baseline pupil diameter, and accommodative function at multiple time points. RESULTS: Thirty-one subjects completed the study (15 dilated with phenylephrine and 16 with tropicamide). Change in pupil diameter from baseline at 2 hours after maximal dilation with 1% PMOS was -1.69 mm and was significantly greater in magnitude compared with placebo for every time point beyond 30 minutes (P < .05). At 2 hours, a greater percentage of study eyes given 1% PMOS returned to baseline pupil diameter compared with placebo (29 vs. 13%, P = .03), which was this also seen at 4 hours (P < .001). More subjects treated with PMOS in the tropicamide subgroup had at least one eye returning to baseline accommodative amplitude at 2 hours (63 vs. 38%, P = .01). There were no severe adverse events, with only mild to moderate conjunctival hyperemia that resolved in most patients by 6 hours. CONCLUSIONS: Phentolamine mesylate ophthalmic solution at 1% reversed medically induced pupil dilation more rapidly than placebo treatment regardless of which mydriatic was used (adrenergic agonists and cholinergic blockers) with a tolerable safety profile.

A recommended "minimum data set" framework for SD-OCT retinal image acquisition and analysis from the Atlas of Retinal Imaging in Alzheimer's Study (ARIAS).

INTRODUCTION: We propose a minimum data set framework for the acquisition and analysis of retinal images for the development of retinal Alzheimer's disease (AD) biomarkers. Our goal is to describe methodology that will increase concordance across laboratories, so that the broader research community is able to cross-validate findings in parallel, accumulate large databases with normative data across the cognitive aging spectrum, and progress the application of this technology from the discovery stage to the validation stage in the search for sensitive and specific retinal biomarkers in AD. METHODS: The proposed minimum data set framework is based on the Atlas of Retinal Imaging Study (ARIAS), an ongoing, longitudinal, multi-site observational cohort study. However, the ARIAS protocol has been edited and refined with the expertise of all co-authors, representing 16 institutions, and research groups from three countries, as a first step to address a pressing need identified by experts in neuroscience, neurology, optometry, and ophthalmology at the Retinal Imaging in Alzheimer's Disease (RIAD) conference, convened by the Alzheimer's Association and held in Washington, DC, in May 2019. RESULTS: Our framework delineates specific imaging protocols and methods of analysis for imaging structural changes in retinal neuronal layers, with optional add-on procedures of fundus autofluorescence to examine beta-amyloid accumulation and optical coherence tomography angiography to examine AD-related changes in the retinal vasculature. DISCUSSION: This minimum data set represents a first step toward the standardization of retinal imaging data acquisition and analysis in cognitive aging and AD. A standardized approach is essential to move from discovery to validation, and to examine which retinal AD biomarkers may be more sensitive and specific for the different stages of the disease severity spectrum. This approach has worked for other biomarkers in the AD field, such as magnetic resonance imaging; amyloid positron emission tomography; and, more recently, blood proteomics. Potential context of use for retinal AD biomarkers is discussed.

Evaluation of an enhanced viscosity artificial tear for moderate to severe dry eye disease: A multicenter, double-masked, randomized 30-day study.

PURPOSE: In a randomized, controlled clinical trial, two lubricant artificial tear formulations with enhanced viscosity were compared: an investigational product at the time, containing carboxymethylcellulose 1.0% and glycerin 0.9% (CMC-GLY) with osmoprotectants, and a standard formula containing carboxymethylcellulose 1.0% alone (CMC). METHODS: This double-masked study recruited patients with moderate to severe dry eye at 10 US centers. After a 7-day run-in with CMC 0.5% (Refresh Tears) patients were randomized to use either CMC-GLY or CMC as needed, but at least 2 times daily for 30 days. Patients were stratified by Ocular Surface Disease Index© (OSDI) score into moderate (23-32) and severe (> 32-65) subgroups. Assessments included OSDI (primary efficacy variable), corneal and conjunctival staining, tear break-up time (TBUT), symptom surveys, and safety variables. Study visits were days 1 (baseline/randomization), 7, and 30. RESULTS: A total of 188 patients (94 CMC-GLY, 94 CMC) were enrolled. The severe subgroup had 67 CMC-GLY and 65 CMC patients. OSDI scores progressively improved and were similar at day 30 between treatment groups. At day 7, only the CMC-GLY group demonstrated significant improvements from baseline in OSDI score (all patients p < 0.001, severe p < 0.001), corneal staining (p = 0.004), and TBUT (p < 0.001). Between-group dose frequency for CMC-GLY was lower at day 7 (p = 0.031). Other efficacy results were similar between groups. The most commonly reported adverse event in both groups was blurred vision. CONCLUSIONS: Overall, the CMC-GLY artificial tear formulation was as effective as the CMC formulation. CMC-GLY demonstrated improvements at an earlier stage (day 7). Both artificial tear formulations were safe and well tolerated, with no treatment-related serious adverse events. These results support the use of the CMC-GLY artificial tear formulation as an effective treatment to reduce the symptoms and signs of dry eye disease.

Dry eye symptoms and impact on vision-related function across International Task Force guidelines severity levels in the United States.

BACKGROUND: International Task Force (ITF) guidelines established a grading scheme to support treatment of dry eye disease based on clinical signs and symptoms. The purpose of this study was to assess the impact of dry eye on vision-related function across ITF severity levels using the Ocular Surface Disease Index (OSDI) questionnaire. METHODS: Non-interventional, cross-sectional study of prescription treatment-naïve dry eye patients seeking symptom relief at 10 ophthalmology and optometry practices. Clinicians assessed corneal and conjunctival staining, tear break-up time, Schirmer's test (type I with anesthesia), and best-corrected visual acuity. Patients completed the OSDI questionnaire and OSDI overall and domain (Symptoms, Visual Function, and Environmental Triggers) scores were compared across ITF guidelines severity levels (1-4). RESULTS: Of 158 patients (mean age, 55 years) enrolled, 52 (33%) were ITF level 1, 54 (34%) ITF level 2, and 52 (33%) ITF levels 3/4 combined. No significant differences were observed in most baseline characteristics. Overall OSDI scores (mean [standard deviation]) were 26.5 [20.0] for ITF level 1, 33.8 [17.5] for ITF level 2, and 44.9 [26.1] for ITF level 3/4 cohorts (P < 0.0001). Component OSDI Symptoms, Visual Function, and Environmental Triggers domain scores all worsened with increasing ITF severity level (P ≤ 0.01). CONCLUSIONS: Dry eye disease has significant deleterious impact on vision-related function across all ITF severity levels.