Status:
COMPLETED
Prospective Study of the Health Benefits of Ultra-Violet Filtering Contact Lenses
Lead Sponsor:
Johnson & Johnson Vision Care, Inc.
Conditions:
Refractive Errors
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to examine the short-term protective effect of Ultra-Violet filtering contact lenses on macular pigment ocular density.
Eligibility Criteria
Inclusion
- The subject is an adapted soft contact lens wearer
- The subject's spherical error equivalent (Best Sphere corrected for back vertex distance) must be from -0.50 diopters (D) to -6.00D or from +0.50D to +4.00D in each eye
- The subject must have a refractive astigmatism in each eye of -0.75D or less
- The subject must have a best corrected visual acuity of 6/9 or better in each eye.
- The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol
- The subject must read and sign the statement of informed consent
- The subject must be at least 18 years of age
Exclusion
- Systemic or ocular allergies which might interfere with contact lens wear
- Systemic disease which might interfere with contact lens wear
- Ocular disease which might interfere with contact lens wear
- Grade 3 or 4 Slit Lamp Findings
- Greater than 0.1 difference in macular pigment optical density (MPOD) findings between right and left eye at baseline visit
- On changing stable medication or taking any medication known to affect tear film
- Active ocular surface pathology
- Use ocular medication
- Had had any anterior ocular surgery or other ocular surgery or injury within 8 weeks immediately prior to enrollment for this study
- Significant ocular tissue anomaly
- Presence of two or more corneal scars in either eye
- Pregnancy or lactation, or intends to become pregnant during the time period of the study
- Any medical condition that may be prejudicial to the study
- Diabetes
- Infectious diseases (e.g. Hepatitis, tuberculosis)
- Contagious immunosuppressive diseases (e.g. HIV)
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01444313
Start Date
January 1 2011
Last Update
June 19 2018
Active Locations (1)
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1
Birmingham, West Midlands, United Kingdom, B4 7ET