Multicenter, Single-masked, Randomized, Parallel, Controlled Study to Compare Senofilcon A Contact Lenses to Currently Used Contact Lenses
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Myopia
- Sponsor
- Johnson & Johnson Vision Care, Inc.
- Enrollment
- 71
- Primary Endpoint
- Limbal Hyperemia (Redness)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of the study is to evaluate the possible benefits of second generation silicone hydrogel contact lenses.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects must:
- •be existing soft contact lens wearers of the study control lenses
- •require a distance visual correction in both eyes
- •have a contact lens spherical distance requirement between -1.00 diopters (D) and -8.00D in both eyes
- •have astigmatism less than or equal to 1.00D in both eyes
- •be able to wear lenses available for this study
- •be corrected to a visual acuity of 6/9 (20/30) or better in each eye
- •have normal eyes with no evidence of abnormality or disease
Exclusion Criteria
- •Subject are excluded for the following reasons:
- •monovision corrected
- •worn lenses extended wear in the last 3 months.
- •require concurrent ocular medication
- •grade 3 or 4 abnormalities
- •grade 3 corneal staining in more than two regions
- •anterior ocular surgery
- •any other ocular surgery or injury within 8 weeks prior to study enrollment
- •abnormal lachrymal secretions
- •pre-existing ocular irritation that would preclude contact lens fitting
Outcomes
Primary Outcomes
Limbal Hyperemia (Redness)
Time Frame: 4 weeks
Subject distribution according to limbal hyperemia scale in each eye during the 4-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.
Bulbar Hyperemia (Redness)
Time Frame: 4 weeks
Subject distribution according to bulbar hyperemia scale in each eye during the 4-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.
Corneal Staining
Time Frame: 4 weeks
Subject distribution according to corneal staining with fluorescein scale in each eye during the 4-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.