Refractive Errors
Conditions
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.
Interventions
Soft contact lenses with UV protection
DEVICEnelfilcon A soft contact lenses
Soft contact lenses without UV protection
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Macular Pigment Optical Density at 9 months | baseline to 9 months |
| Macular Pigment Optical Density at 15 months | baseline to 15 months |
Secondary
| Measure | Time frame |
|---|---|
| Macular Pigment Optical Density at 6 months | baseline to 6 months |
| Macular Pigment Optical Density at 12 months | baseline to 12 months |
| Macular Pigment Optical Density at 3 months | baseline to 3 months |
Countries
United Kingdom
Outcome results
None listed