Clinical Performance of Two Frequent Replacement Silicone Hydrogel Multifocal Contact Lenses
- Conditions
- Presbyopia
- Registration Number
- NCT06469242
- Lead Sponsor
- Alcon Research
- Brief Summary
The purpose of this study is to evaluate the on-eye multifocal clinical performance of investigational LID233309 contact lenses and Oasys multifocal (MF) contact lenses in a daily wear dispensing trial.
- Detailed Description
Subjects will be expected to attend 7 office visits for an individual duration of participation of 28 to 40 days.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 96
- Current wearer of biweekly/monthly replacement multifocal soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 6 months.
- Manifest cylinder equal to or less than 0.75 diopter (D) in each eye.
- Able to wear contact lenses within the available power range with a near ADD of +0.75 D to +2.50 D in each eye.
- Other protocol-defined inclusion criteria may apply.
Key
- Currently pregnant or lactating.
- History of amblyopia, strabismus, or binocular vision abnormalities.
- Habitual Oasys MF contact lens wearers or daily disposable contact lens wearers.
- Monovision contact lens wearers and wearers of contact lens in one eye only.
- Other protocol-defined exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Binocular visual acuity at distance (4 meters) at Week 1 Week 1 (Day 7 -0/+1 days) of each wear period. A wear period is 14 days (-0/+2 days) according to randomization assignment. Visual Acuity (VA) will be assessed at a distance of 4 meters for both eyes together under high contrast, high illumination lighting with study lenses in place. VA will be measured using letter charts and recorded in logarithm minimum angle of resolution (logMAR), with a logMAR value of 0 equating to 20/20 Snellen VA (normal distance eyesight) and lower logMAR values representing better eyesight.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (8)
Kurata Eyecare Center
🇺🇸Los Angeles, California, United States
Elsa Pao, OD
🇺🇸Oakland, California, United States
Drs. Giedd, P.A.
🇺🇸Maitland, Florida, United States
Vision Health Institute
🇺🇸Orlando, Florida, United States
Wesley Optometric Consulting
🇺🇸Medina, Minnesota, United States
ProCare Vision Centers, Inc.
🇺🇸Granville, Ohio, United States
Insight Research Clinic LLC
🇺🇸Powell, Ohio, United States
Optometry Group, PLLC
🇺🇸Memphis, Tennessee, United States
Kurata Eyecare Center🇺🇸Los Angeles, California, United States