Clinical Assessment of a Daily Wear Monthly Replacement Silicone Hydrogel Toric Contact Lens
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Refractive Errors
- Sponsor
- Alcon Research
- Enrollment
- 76
- Locations
- 7
- Primary Endpoint
- Distance Visual Acuity (VA) With Study Lenses
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of this clinical study is to assess the clinical performance of an investigational toric soft contact lens compared to a commercially available toric contact lens in a crossover dispense trial when worn in a daily wear modality for 30 days, each study lens type.
Detailed Description
Subjects will be randomized to 1 of 2 crossover wear sequences. Subjects will be expected to attend 5 office visits, for a total individual duration of participation in the study of approximately 60 days.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Successful wearers of weekly/monthly toric soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months;
- •Best corrected distance visual acuity (as determined by manifest refraction at screening) better than or equal to 20/25 Snellen in each eye.
- •Able to wear contact lenses within the range of available sphere \& cylinder power and axes.
- •Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- •Daily disposable contact lens wearers.
- •Monovision and multifocal contact lens wearers.
- •Habitual Biofinity Toric/Biofinity Toric XR contact lens wearers in the past 3 months prior to consent.
- •Other protocol-defined exclusion criteria may apply.
Outcomes
Primary Outcomes
Distance Visual Acuity (VA) With Study Lenses
Time Frame: Day 1 and Day 30, each wear period (approximately 30 days)
Visual acuity (VA) was collected for each eye individually with study lenses in place 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 inferences were pre-specified for the primary effectiveness endpoint; therefore, no hypothesis testing was performed.