Clinical Performance of Two Frequent Replacement Silicone Hydrogel Multifocal Contact Lenses

Not Applicable

Completed

• 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 wear two different contact lens study products in a cross-over fashion. Each study product type will be worn for approximately 14 days. A washout period of 2-4 days will occur prior to the first wear period and between the two wear periods. Subjects will be expected to attend 7 office visits. The total duration of study participation is approximately 40 days with approximately 28 days of lens wear.

Study Timeline

• Study First Submitted: 2024-06-17
• Study First Submitted QC: 2024-06-17
• Study First Posted: 2024-06-21
• Study Start: 2024-07-18
• Primary Completion: 2024-10-08
• Study Completion: 2024-10-08
• Status Verified: 2025-09
• Results First Submitted: 2025-09-22
• Results First Submitted QC: 2025-09-22
• Last Update Submitted: 2025-09-22
• Results First Posted: 2025-10-09
• Last Update Posted: 2025-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

• 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

Exclusion Criteria

• 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
Mean Binocular Visual Acuity at Distance (4 Meters) at Week 1	Week 1 (Day 7 -0/+1 days) of each wear period. A wear period was 14 days (-0/+2 days) according to randomization assignment.	Visual Acuity (VA) was assessed at a distance of 4 meters with both eyes together (binocular) under high contrast, high illumination lighting with study lenses in place. VA was measured using letter charts and recorded in the logarithm of the minimum angle of resolution (LogMAR). A LogMAR value of 0 equates to 20/20 Snellen VA (normal distance eyesight), with negative LogMAR values representing better than 20/20 VA. The LogMAR VA scale ranges from -0.30 (20/10 Snellen) to 1.00 (20/200 Snellen). No hypothesis testing was pre-specified for this endpoint.

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