A Study to Assess the Safety and Efficacy of a Daily Disposable Contact Lens

Study Overview
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Brief Summary
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The objective of this study is to evaluate the safety and efficacy of the Bausch & Lomb daily disposable tint contact lens (Test) compared to a currently marketed daily disposable cosmetic tint contact lens (Control).

Official Title
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A Study to Assess the Safety and Efficacy of a Daily Disposable Contact Lens

Conditions
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Myopia

Intervention / Treatment
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* Device: Bausch & Lomb contact lens
* Device: Marketed daily disposable contact lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must have clear central corneas and be free of any anterior segment disorders. Subjects must be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand. Subjects must be correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye. Subjects must be of Asian descent. Subjects must require plano or myopic correction and must require contact lens correction from plano to -6.00 D in both eyes. Exclusion Criteria: Subjects who have any systemic disease affecting ocular health. Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance. Subjects with an active ocular disease or are using any ocular medication. Subjects with any Present finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear. Subjects with any scar or neovascularization within the central 4 mm of the cornea. Subjects with minor peripheral corneal scarring (that does not extend into the central area), that in the Investigator's judgment, does not interfere with contact lens wear, are eligible for this study. Subjects who currently wear monovision, multifocal, or toric contact lenses. Subjects who are adapted wearers of 1-Day Acuvue Define daily disposable cosmetic tint contact lenses.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bausch & Lomb contact lens<br>Bausch & Lomb daily disposable cosmetic tint contact lens | Device: Bausch & Lomb contact lens<br>* Bausch & Lomb daily disposable cosmetic tint contact lens<br>|
| Active Comparator: Marketed daily disposable contact lens<br>Marketed daily disposable cosmetic tint contact lens | Device: Marketed daily disposable contact lens<br>* Marketed daily disposable cosmetic tint contact lens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Slit Lamp Findings | Graded Slit lamp findings (epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates) > grade 2 over all follow-up visits, summarizes the worst case over all follow-up visits. Graded 0-4 with 0=none and 4=severe | Summarized over all follow-up visits through 1 month | 
| logMAR Visual Acuity (VA) | Non-inferiority of distance high contrast logMAR lens VA. A negative value indicates improved VA. Lens VA was established for All Study, Dispensed, 2-Week Follow-up Visit, and 1-Month Follow-up Visit | Summarized over all visits, and dispensed visit | 
| logMAR Visual Acuity (VA) | Non-inferiority of distance high contrast logMAR lens VA. A negative value indicates improved VA. Lens VA was established for All Study, Dispensed, 2-Week Follow-up Visit, and 1-Month Follow-up Visit | 2 week and 1 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lens Wettability | Lens wettability was rated as Grade 4-0. Grade 4 = 100% of anterior surface wettable (optimal); Grade 3 = presence of small (< 0.1 mm), individual, discrete non-wetting areas (slight); Grade 2 = presence of single area of non-wetting between 0.1 mm and 0.5 mm in size (mild); Grade 1 = presence of several areas on non-wetting, each between 0.1 mm and 0.5 mm in size (moderate); Grade 0 = presence of one or more non-wetting areas > 0.5 mm in size (severe). Suboptimal lens wettability was defined as a rating other than Grade 4, ie slight, mild, moderate, or severe ratings. Over All Visits summarizes the worst case over the dispensing and all follow-up visits. | Summarized over all follow-up visits through 1 month | 
| Lens Deposits | Degree of lens deposits was assessed as none, light, medium, or heavy. Suboptimal lens deposits were defined as a degree rating of medium or heavy. Measured over all visits through one month | Summarized over all follow-up visits through one month | 
| Lens Centration | Lens centration was assessed as excellent(fully centered), good (slight decentration, no corneal exposure), fair (decentration, intermittent corneal exposure), or poor (incomplete corneal coverage and/or edge lift). Suboptimal lens centration was defined as a rating other than excellent. | Summarized over all follow-up visits through 1 month | 
| Lens Movement | Lens movement was assessed as adequate, excessive (> 0.6 mm), insufficient (< 0.2 mm), or adherence. Suboptimal lens movement was defined as a rating other than adequate. | Summarized over all follow-up visits through one month | 
| Symptoms & Complaints | Subject symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting least favorable symptoms/complaints and 100 being the most favorable score. | Summarized over all follow-up visits through one month |