Status:
COMPLETED
Clinical Comparison of Two Marketed Reusable Cosmetic Contact Lenses
Lead Sponsor:
Johnson & Johnson Vision Care, Inc.
Conditions:
Visual Acuity
Eligibility:
FEMALE
18-29 years
Phase:
NA
Brief Summary
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 se...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 26 2018
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT03755882
Start Date
November 5 2018
End Date
December 26 2018
Last Update
February 5 2020
Active Locations (1)
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1
Sun Yat-Sen University Zhongshan Ophthalmic Center
Guanzhou, China