Objective Vision Evaluation of Two Cosmetic Contact Lenses

Study Overview
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Brief Summary
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This is a single visit, single site, brand-masked, non-dispensing, 2×2 bilateral crossover study. Each subject will be bilaterally fitted with one of the two test articles in each of the study periods.

Official Title
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Objective Vision Evaluation of Two Cosmetic Contact Lenses

Conditions
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Visual Acuity

Intervention / Treatment
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* Device: JJVC Investigational Contact Lens
* Device: 1-DAY ACUVUE® DEFINE® Radiant Sweet™


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. Subjects between 18 and 39 (inclusive) years of age at the time of screening 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. The subject must be willing to be photographed and/or video-taped. The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 D to -5.00 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 visual acuity of 20/25 or better in each eye. 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: 39 Years

Sexes Eligible for Study
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All

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>Eligible Subjects aged 18 to 39 years (inclusive) who are habitual soft contact lens wearers will be randomized into sequence, Test/Control | Device: JJVC Investigational Contact Lens<br>* TEST<br>Device: 1-DAY ACUVUE® DEFINE® Radiant Sweet™<br>* CONTROL<br>|
| Experimental: Control/Test<br>Eligible Subjects aged 18 to 39 years (inclusive) who are habitual soft contact lens wearers will be randomized into sequence, Control/Test. | Device: JJVC Investigational Contact Lens<br>* TEST<br>Device: 1-DAY ACUVUE® DEFINE® Radiant Sweet™<br>* CONTROL<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance Binocular Visual Acuity (logMAR) | Visual acuity on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at distance (4 meters) under high luminance high contrast, high luminance low contrast and low luminance high contrast with distance goggles using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. Letter-by-letter results calculated the visual performance score for each chart read. logMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR value of 0.0 is equivalent to 20/20 Snellen vision. | 20- Minutes Post-Lens Fitting | 
| Near BinocularVisual Acuity (logMAR) | Visual acuity on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at near (40 cm) under High luminance low contrast and low luminance high contrast with distance goggles using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. Letter-by-letter results calculated the visual performance score for each chart read. logMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR value of 0.0 is equivalent to 20/20 Snellen vision. | 20- Minutes Post-Lens Fitting | 
| Quantitative Visual Acuity | Quantitative Visual Acuity (qVA) was measured at distance (4 meter) under low room illumination (4 lux), low luminance, high contrast conditions in the right eye only and in both eyes using AST Sentio vision Testing System. During testing 25 triplets of test letters were displayed on a large stationary monitor (118 CM), the operator recorded the patient's responses using the remote (Android Tablet). After a testing session had been completed the software calculated the VA threshold. VA threshold was defined as the logMAR stimulus size at which the expected probability of correct letter identification is 66%. when both eyes are measured. The average median VA threshold was reported for each lens. Lower values indicate better vision. | 20- Minutes Post-Lens Fitting | 
| Area Under Contrast Sensitivity Function Curve | Area under the log Curve was measured at 1.5, 3, 6, 12 and 18 cycles per degree (cpd) in the right eye only and in both eyes using AST Sentio vision Testing System. During testing 25 triplets of test letters were displayed on a large stationary monitor (118 CM), the operator recorded the patient's responses using the remote (Android Tablet). After a testing session had been completed the software calculated the Area under the log contrast sensitivity function from 1.5 cpd to 18 cpd. The average area under the log curve was reported for each lens. Higher values indicate better vision. Number of eyes is 50 when both eyes are measured. | 20- Minutes Post-Lens Fitting |