Clinical Performance Assessment of a Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lens
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Refractive Errors
- Sponsor
- Alcon Research
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Distance VA (logMAR) With Study Lenses
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The purpose of this study is to obtain on-eye performance data to inform contact lens product development.
Detailed Description
Subjects are expected to attend 5 scheduled visits. The expected duration of subject participation in the study is approximately 60 days, with approximately 30 days (± 2 days) per product.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Sign Informed Consent document.
- •Successful wear of spherical weekly/monthly soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months.
- •Possess spectacles that provide a corrected visual acuity of 20/40 or better in both eyes.
- •Other protocol-specified inclusion criteria may apply.
- •Exclusion Criteria
- •Any eye condition or disease or use of medication that contraindicates contact lens wear.
- •Eye surgery, irregular cornea, eye injury as specified in the protocol.
- •Routinely sleeps in contact lenses at least 1 night per week over the last 3 months prior to enrollment.
- •Any use of topical ocular medications, artificial tear or rewetting drops that would require instillation during contact lens wear.
- •Habitually wears Biofinity contact lenses.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Distance VA (logMAR) With Study Lenses
Time Frame: Day 30 after a minimum of 6 hours of wear, each product
Visual acuity (VA) was collected for each eye individually with study lenses in place at a distance of 4 meters using a letter chart. VA was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned.