Clinical Performance of Two Frequent Replacement Silicone Hydrogel Multifocal Contact Lenses

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.

Completed

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Key information

Conditions

Presbyopia Eye Diseases Hyperopia Myopia Refractive Errors

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kurata Eyecare Center, Los Angeles, California, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key 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.

Treatment and study plan

Serafilcon A multifocal contact lenses

Device

Investigational multifocal soft contact lenses

Other names: LID233309

Senofilcon A multifocal contact lenses

Device

Commercially available multifocal soft contact lenses

Other names: ACUVUE® OASYS MULTIFOCAL with PUPIL OPTIMIZED DESIGN, Oasys MF

CLEAR CARE® Cleaning & Disinfecting Solution

Device

Hydrogen peroxide-based contact lens cleaning and disinfection system

Other names: CLEAR CARE

Primary outcomes

Mean Binocular Visual Acuity at Distance (4 Meters) at Week 1

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Jun 21, 2024
Registry last updated: Oct 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed