Clinical Evaluation of a Manufacturing Process for a Frequent Replacement Silicone Hydrogel Multifocal Contact Lens
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Alcon Research
- Enrollment
- 18
- Locations
- 2
- Primary Endpoint
- Binocular Visual Acuity (VA) With Study Lenses at 4 Meters (logMAR)
Study Overview
Brief Summary
The purpose of this clinical trial was to evaluate the clinical performance of a manufacturing process on a frequent replacement multifocal contact lens.
Detailed Description
Subjects will be expected to attend 3 scheduled visits. Eligible subjects will wear each study lens type in a cross-over fashion for approximately 2 days.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Able to understand and sign an consent form (ICF) that has been approved by an Institutional Review Board (IRB);
- •Willing to stop wearing habitual contact lenses for the duration of study participation;
- •Currently wearing multifocal soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;
- •Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- •Any eye infection, inflammation, or abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the investigator;
- •Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the investigator;
- •History of refractive surgery, or plan to have refractive surgery during the study;
- •Current or history of dry eye in either eye that would preclude contact lens wear, in the opinion of the investigator;
- •Monovision contact lens wear;
- •Other protocol-defined exclusion criteria may apply.
Outcomes
Primary Outcomes
Binocular Visual Acuity (VA) With Study Lenses at 4 Meters (logMAR)
Time Frame: Day 2, each study lens type worn during the corresponding crossover period
VA was assessed binocularly (both eyes together) using a letter chart and measured in 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 hypothesis testing was prespecified for this endpoint.
Secondary Outcomes
No secondary outcomes reported