Clinical Performance of Two Frequent Replacement Silicone Hydrogel Multifocal Contact Lenses

Alcon Research106 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

106

Conditions

Presbyopia

Interventions

Serafilcon A multifocal contact lensesDEVICE

Investigational multifocal soft contact lenses

Senofilcon A multifocal contact lensesDEVICE

Commercially available multifocal soft contact lenses

CLEAR CARE® Cleaning & Disinfecting SolutionDEVICE

Hydrogen peroxide-based contact lens cleaning and disinfection system

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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.

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

Outcomes

Primary Outcomes

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

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.

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.

Data from ClinicalTrials.gov

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