Clinical Evaluation of a Daily Wear Frequent Replacement Silicone Hydrogel Lens
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Refractive Errors
- Sponsor
- Alcon Research
- Enrollment
- 120
- Locations
- 8
- Primary Endpoint
- Distance Visual Acuity (VA) With Study Lenses - Completed Eyes
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The purpose of this clinical study is to demonstrate the safety and performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn in a daily wear modality.
Detailed Description
Subjects will be randomized to wear either the investigational contact lenses or the commercially available contact lenses in both eyes. Subjects will be expected to attend 6 scheduled study visits. Individual participation in the study will be approximately 3 months.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Successful wear of spherical daily wear frequent replacement soft contact lenses for distance correction in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day.
- •Manifest cylinder ≤ 0.75 diopter (D) in each eye.
- •Other protocol-specified inclusion criteria may apply.
Exclusion Criteria
- •Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment.
- •Monovision contact lens wearers.
- •Habitually wearing Biofinity® lenses.
- •Other protocol-specified exclusion criteria may apply.
Outcomes
Primary Outcomes
Distance Visual Acuity (VA) With Study Lenses - Completed Eyes
Time Frame: Day 1 Dispense; Week 1 Follow-up; Week 2 Follow-up; Month 1 Follow-up; Month 2 Follow-up; Month 3 Follow-up/Exit (at least 4 hours after lens insertion at each follow-up assessment visit)
Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters using a letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity. No formal hypothesis testing was planned.
Distance Visual Acuity (VA) With Study Lenses - Discontinued Eyes
Time Frame: Day 1 Dispense; Week 1 Follow-up; Week 2 Follow-up; Month 1 Follow-up; Month 2 Follow-up (at least 4 hours after lens insertion at each follow-up assessment visit)
Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters using a letter chart. VA was collected in Snellen and converted to the logarithm minimum angle of resolution (logMAR) scale. A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity. No formal hypothesis testing was planned.