Product Performance of a Daily Disposable Contact Lens

Study Overview
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Brief Summary
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The objective of this one week, single group, bilateral, open-label study is to evaluate the product performance of the Bausch & Lomb daily disposable cosmetic tint contact lens (Test) when worn on a daily disposable basis by adapted current wearers of a marketed opaque tinted soft contact lens.

Official Title
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A Study to Assess the Product Performance of a Daily Disposable Contact Lens

Conditions
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Myopia

Intervention / Treatment
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* Device: Daily disposable cosmetic tint lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must be females of Chinese descent and of legal age and no older than 38. OR subjects that are females of Chinese descent and are at least 15 years of age and less than the legal age must: have a parent/legal guardian provide informed consent. Subjects must have clear central corneas and be free of any anterior segment disorders. Subjects must be adapted current wearers of marketed opaque tinted soft contact lenses, wear their lenses two days or more per week, and wear a lens in each eye. Exclusion Criteria: Subjects who have worn gas permeable (GP) contact lenses within the last 30 days or have worn polymethylmethacrylate (PMMA) lenses within the last three months. 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 scar or neovascularization within the central 4 mm of the cornea. Subjects who are aphakic or amblyopic. Subjects who have had any corneal surgery (eg, refractive surgery). Subjects who currently wear monovision, multifocal, or toric contact lenses.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 38 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prism I<br>Bausch & Lomb daily disposable cosmetic tint contact lens | Device: Daily disposable cosmetic tint lens<br>* Bausch & Lomb daily disposable cosmetic tint contact lens worn on a daily disposable basis for 1 week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Market Research Survey | Online subjective assessments that subjects responded to after wearing the study lenses for at least one week. Subjects were asked to rate their overall opinion as: Excellent, Very Good, Good, Fair, or Poor. | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lens Evaluation - Centration | To determine proper lens parameters the lens relationship to the eye was observed using a slit lamp. Lens centration, meaning the lens should provide full corneal coverage, was assessed during the slit lamp evaluation. Findings were reported as: Excellent, Good, Fair, or Poor. | Over all study visits through 1 week | 
| Lens Evaluation - Movement | To determine proper lens parameters the lens relationship to the eye was observed using a slit lamp. Lens movement, meaning the lens should provide discernible movement with: Primary gaze blink Upgaze blink Upgaze lag was assessed during the slit lamp evaluation. Findings were reported as: Adequate, Excessive, Insufficient, Adherence. | Over all study visits through 1 week | 
| Visual Acuity - Distance High Contrast logMAR (Logarithm of the Minimum Angle of Resolution) Lens Visual Acuity (VA). | For determination of high contrast VA, the subject was to be seated so that the distance from the subject's eyes to the logMAR chart is 6.5 feet (2.0 meters). The chart should be at eye level for the subject. The logMAR charts have two alternative letter sequences from 28 letters (0.3 logMAR) to 62 letters (-0.3 logMAR). The visual acuity should be measured through the phoropter using the distance refractive correction with the addition of +0.50D to compensate for the reduced test distance of 6.5 feet (2.0 meters). | Over all study visits for 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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contact lens