Clinical Comparison of 2 Daily Disposable Contact Lenses - Pilot Study 1
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Refractive Errors
- Sponsor
- Alcon Research
- Enrollment
- 56
- Locations
- 4
- Primary Endpoint
- Distance Visual Acuity (VA) With Study Lenses
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The primary objective of this study is to evaluate the overall performance of PRECISION1 contact lenses when compared to Biotrue ONEday contact lenses.
Detailed Description
Subjects are expected to attend 3 study visits and wear the PRECISION1 and Biotrue ONEday study lenses in a crossover design for approximately 8 days of exposure to each study lens type. The expected duration of subject participation is up to 22 days.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject must be able to understand and must sign an Institution Review Board (IRB) approved Informed Consent Form.
- •Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months.
- •Willing to wear contact lenses for at least 16 hours per day on one of the days with each lens type.
- •Other protocol-specified inclusion criteria may apply.
Exclusion Criteria
- •Any ocular condition that contraindicates contact lens wear.
- •Previous or current habitual wearer of PRECISION1, Biotrue ONEday, or DAILIES TOTAL1 contact lenses.
- •Other protocol-specified exclusion criteria may apply.
Outcomes
Primary Outcomes
Distance Visual Acuity (VA) With Study Lenses
Time Frame: Day 8 (-0/+3 days) after 10 (-2/+6) hours of wear, each study lens type
Distance VA was assessed with study lenses in place. VA was collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity. No formal hypothesis was predefined for the primary endpoint. No inferential testing was performed.