Clinical Assessment of Two Reusable Silicone Hydrogel Contact Lenses

Alcon Research166 enrolled

Overview

The purpose of this study is to compare the clinical performance of LID018869 soft contact with ACUVUE® OASYS with HYDRACLEAR® PLUS (AOHP) soft contact lenses over 30 days of daily wear.

Subjects will be expected to attend 6 visits. Subjects will be expected to wear their study contact lenses every day for at least 10 hours per day over a 30-day period for each study lens type. The total duration of a subject's participation in the study will be approximately 65 days.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

166

Conditions

Refractive Errors

Interventions

Lehfilcon A contact lensesDEVICE

Commercially available, silicone hydrogel, spherical contact lenses used as indicated

Senofilcon A contact lensesDEVICE

Commercially available, silicone hydrogel, spherical contact lenses used as indicated

CLEAR CAREDEVICE

Hydrogen peroxide-based contact lens cleaning and disinfecting solution

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * Current wearer of a commercial spherical weekly/monthly soft contact lenses with at least 3 months of wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day. * Manifest cylinder less than or equal to 0.75 diopter in each eye. * Best corrected distance visual acuity better than or equal to 20/25 Snellen in each eye. * Other protocol-defined inclusion criteria may apply. Key Exclusion Criteria: * Monovision or multifocal lens wearer. * Habitual senofilcon contact lens wearer (for example, Acuvue Oasys, Acuvue Vita) or commercially available lehfilcon A contact lens wearer (TOTAL30). * Routinely sleeps in habitual contact lenses. * Other protocol-defined exclusion criteria may apply.

Locations (10)

Dr. Elsa Pao, OD

Oakland, California, United States

Pacific Rims Optometry

San Francisco, California, United States

Sabal Eye Care

Longwood, Florida, United States

Outcomes

Primary Outcomes

Least Squares Mean Distance Visual Acuity With Study Lenses at Day 30

Visual acuity (VA) was collected for each eye individually with study lenses in place at a distance of 4 meters using a letter chart. VA was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity.

Time frame: Day 30, each study lens type

Data from ClinicalTrials.gov

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