Clinical Evaluation of Daily Disposable Etafilcon A Cosmetic Contact Lenses
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 89
- Locations
- 2
- Primary Endpoint
- Proportion of Eyes With LogMAR Visual Acuity Less Than 0.176 (20/30 Snellen Acuity)
Study Overview
Brief Summary
This is a multi-site, 4-visit, brand-masked, bilateral, 2x2 cross-over dispensing study to evaluate visual acuity.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
Brand masking: subjects, investigators, and clinical site personnel will be unaware of the identity (brand) of both study lenses.
Eligibility Criteria
- Ages
- 18 Years to 29 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
- •Females between 18 and 29 (inclusive) years of age at the time of screening
- •Appear able and willing to adhere to the instructions set forth in this clinical protocol (i.e. willing to wear only the study lenses and not use habitual lenses during the dispensing periods)
- •Be a current soft contact lens wearer in both eyes with a minimum of 6 hours/day and 5 days/week over the last 30 days by self-report
- •Be a current wearer of cosmetic/circle lenses in the last 6 months, 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 -6.00 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.)
- •Any previous history or signs of a contact lens-related corneal inflammatory event (eg, past peripheral ulcer or round peripheral scar), or any other ocular abnormality that would contraindicate contact lens wear (at the investigators discretion).
- •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.
Arms & Interventions
TEST/CONTROL
Eligible subjects will be randomized to the wear sequence (TEST/CONTROL) to wear the study lenses during each dispensing period (5 to 7 days) with a wash-out period (2 to 5 days) between wears.
Intervention: TEST LENS (Device)
TEST/CONTROL
Eligible subjects will be randomized to the wear sequence (TEST/CONTROL) to wear the study lenses during each dispensing period (5 to 7 days) with a wash-out period (2 to 5 days) between wears.
Intervention: CONTROL LENS (Device)
CONTROL/TEST
Eligible subjects will be randomized to the wear sequence (CONTROL/TEST) to wear the study lenses during each dispensing period (5 to 7 days) with a wash-out period (2 to 5 days) between wears.
Intervention: TEST LENS (Device)
CONTROL/TEST
Eligible subjects will be randomized to the wear sequence (CONTROL/TEST) to wear the study lenses during each dispensing period (5 to 7 days) with a wash-out period (2 to 5 days) between wears.
Intervention: CONTROL LENS (Device)
Outcomes
Primary Outcomes
Proportion of Eyes With LogMAR Visual Acuity Less Than 0.176 (20/30 Snellen Acuity)
Time Frame: 5-minutes post-lens-fitting
Visual acuity on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at distance (4 meters) under high luminance low contrast and low luminance high contrast lighting conditions 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. However, the data was dichotomized as Y=1 if logMAR visual acuity was less than 0.176 logMAR; and Y=0 otherwise. A value of 0.176 logMAR ≅20/30 Snellen Visual Acuity. The proportion of eyes with visual acuity lower than 0.176 logMAR was reported.
Secondary Outcomes
No secondary outcomes reported