Clinical Performance Evaluation of Two Frequent Replacement Silicone Hydrogel Multifocal Toric Contact Lenses
- Conditions
- AstigmatismPresbyopia
- Registration Number
- NCT06461455
- Lead Sponsor
- Alcon Research
- Brief Summary
The purpose of this study is to evaluate on-eye clinical performance of the investigational contact lenses following 30 days of wear in the intended population.
- Detailed Description
Participants will be expected to attend 5 office visits for an individual duration of participation of approximately 64 days.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 88
- Habitual wearer of biweekly/monthly replacement soft multifocal or multifocal toric contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;
- Manifest cylinder equal to or greater than 0.75 diopter (D) in each eye at Screening;
- Willing to not use readers while wearing study contact lenses for duration of the study;
- Other protocol-defined inclusion criteria may apply.
Key
- Use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear;
- Wears 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 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 Day 30 with study lenses Day 30 (-2/+1) of each wear period. A wear period is 30 days (-2/+1) according to randomization assignment.] High contrast, high illumination visual acuity (VA) will be assessed at a distance of 4 meters for both eyes together 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 (11)
Dr.Elsa Pao, O.D
🇺🇸Oakland, California, United States
Pacific Rims Optometry
🇺🇸San Francisco, California, United States
Drs. Giedd, P.A.
🇺🇸Maitland, Florida, United States
Vision Health Institute
🇺🇸Orlando, Florida, United States
Kannarr Eye Care LLC
🇺🇸Pittsburg, Kansas, United States
Wesley Optometric Consulting
🇺🇸Medina, Minnesota, United States
Oculus Research, Inc.
🇺🇸Garner, North Carolina, 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
Scroll for more (1 remaining)Dr.Elsa Pao, O.D🇺🇸Oakland, California, United States