Clinical Comparison of Two Marketed Reusable Cosmetic Contact Lenses

Study Overview
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Brief Summary
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This will be a 4-visit, multi-site, randomized, brand-masked, bilateral, 2×2 crossover study. If a subject is found to meet all eligibility criteria, they will be randomized to one of two lens wear sequences. Each lens type will be worn for approximately 2 weeks.

Official Title
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Clinical Comparison of Two Marketed Reusable Cosmetic Contact Lenses

Conditions
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Visual Acuity

Intervention / Treatment
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* Device: ACUVUE® DEFINE™ Vivid Style
* Device: LACELLE™ Sparkling Brown


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Potential subjects must satisfy all of the following criteria to be enrolled in the study: The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form. Appear able and willing to adhere to the instructions set forth in this clinical protocol (ie, willing to wear only the study lenses and not use habitual lenses during the study). Females between 18 and 29 (inclusive) years of age at the time of screening The subject's vertex corrected spherical equivalent distance refraction must be in the range of -2.00 D to -7.00 D (inclusive) in each eye. The subject's refractive cylinder must be less than or equal to 0.75 D (inclusive) in each eye. Have spherical best corrected logMAR visual acuity (VA) of 0.18 or better in each eye. Be a current soft contact lens wearer in both eyes with a minimum of 6 hours/day and 5 days/week over the last month by self-report. Must be habitual reusable (2 week, or monthly), cosmetic contact lenses wearers. The subject must be willing to be photographed and/or video-taped Exclusion Criteria: Potential subjects who meet any of the following criteria will be excluded from participating in the study: Currently pregnant or lactating Any systemic disease (eg, Sjögren's Syndrome), allergies, infectious disease (eg, hepatitis, tuberculosis), contagious immunosuppressive diseases (eg, HIV), autoimmune disease (eg rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study (at the investigators discretion). Use of systemic medications (eg, chronic steroid use) that are known to interfere with contact lens wear (at the investigators discretion). Any previous, or planned (during the study) ocular surgery (eg, radial keratotomy, PRK, LASIK, etc.) Participation in any contact lens or lens care product clinical trial within seven (7) days prior to study enrollment. Employee or family members of clinical site (eg, Investigator, Coordinator, Technician). Any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion (at the investigators discretion). Clinically significant (Grade 3 or 4 on FDA scale) tarsal abnormalities, bulbar injection, corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 29 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TEST/CONTROL<br>Female subjects between the ages of 18 to 29 years who are habitual reusable soft cosmetic contact lens wearers will be randomized into one of two lens sequences. | Device: ACUVUE® DEFINE™ Vivid Style<br>* TEST Lens<br>* Other names: etafilcon A;Device: LACELLE™ Sparkling Brown<br>* CONTROL Lens<br>* Other names: helifilcon A;|
| Experimental: CONTROL/TEST<br>Female subjects between the ages of 18 to 29 years who are habitual reusable soft cosmetic contact lens wearers will be randomized into one of two lens sequences. | Device: ACUVUE® DEFINE™ Vivid Style<br>* TEST Lens<br>* Other names: etafilcon A;Device: LACELLE™ Sparkling Brown<br>* CONTROL Lens<br>* Other names: helifilcon A;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Performance | Monocular visual performance (logMAR) was evaluated under 3 conditions (1.high luminance and high contrast, 2. High Lumiance Low Contrast and 3. Low Luminance High Contrast with distance goggles) at 4 meters using Early Treatment Diabetic Retinopathy Study (ETDRS) charts. Letter-by-letter results were calculated to ascertain the visual performance score for each chart read. LogMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20. | Up to 2-Week Follow-up |