Product Performance of a Daily Disposable Contact Lens

Not Applicable

Completed

Brief Summary: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Prism I	Daily disposable cosmetic tint lens	Bausch \& Lomb daily disposable cosmetic tint contact lens

Primary Outcome Measures

Name	Time	Method
Market Research Survey	1 week	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.

Secondary Outcome Measures

Name	Time	Method
Lens Evaluation - Movement	Over all study visits through 1 week	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.
Lens Evaluation - Centration	Over all study visits through 1 week	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.
Visual Acuity - Distance High Contrast logMAR (Logarithm of the Minimum Angle of Resolution) Lens Visual Acuity (VA).	Over all study visits for 1 week	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).