Clinical Evaluation of a Daily Wear Silicone Hydrogel Lens
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Refractive Errors
- Sponsor
- Alcon Research
- Enrollment
- 249
- Locations
- 18
- Primary Endpoint
- Least Squares Mean Contact Lens Corrected Distance Visual Acuity (CLCDVA) in Each Eye (CLL949-C018 + CLL949-C009)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The purpose of this clinical study is to assess 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 with frequent replacement.
Detailed Description
Subjects will attend 4 office visits: Screening/Baseline/Dispense; Week 1 Follow-up; Month 1 Follow-up; and Month 3 Follow-up/Exit. The total expected duration of participation for each subject is approximately 3 months.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Understand and sign an IRB/IEC approved Informed Consent form.
- •Willing and able to attend all scheduled study visits and wear the assigned study lenses as required per protocol.
- •Successful wear of frequent replacement, spherical, daily wear 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.
- •Best spectacle corrected visual acuity 20/20 or better in each eye.
- •Other protocol-defined 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 wear.
- •Any habitual wear of Biofinity lenses.
- •Other protocol-defined exclusion criteria may apply.
Outcomes
Primary Outcomes
Least Squares Mean Contact Lens Corrected Distance Visual Acuity (CLCDVA) in Each Eye (CLL949-C018 + CLL949-C009)
Time Frame: Week 1 Follow-Up
Visual acuity (VA) was assessed for each eye individually with study lenses in place 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.
Secondary Outcomes
- Percentage of Subjects Achieving CLCDVA 20/20 or Better in Each Eye (CLL949-C018 + CLL949-C009)(Week 1 Follow-Up, at least 4 hours after lens insertion)