Subjective Comfort With Multipurpose Care Solutions in Soft Contact Lens Wearers

N/ACompletedNCT01211535

Alcon Research104 enrolled

Overview

The purpose of this study was to assess the comfort of OPTI-FREE RepleniSH in soft contact lens wearers.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

104

Conditions

Myopia Astigmatism Refractive Error

Interventions

OPTI-FREE RepleniSH multipurpose solutionDEVICE

FDA-approved, multipurpose solution used as indicated for cleaning, rinsing, conditioning, disinfecting, and storing study contact lenses on a daily wear basis for 14 days

ReNu Biotrue multipurpose solutionDEVICE

FDA-approved, multipurpose solution used as indicated for cleaning, disinfecting, daily protein removing, and storing study contact lenses on a daily wear basis for 14 days

Silicone hydrogel contact lensesDEVICE

Silicone hydrogel contact lenses per subject's habitual brand and prescription worn on a daily wear basis for 14 days, with either OPTI-FREE RepleniSH or ReNu Biotrue used for contact lens care

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Currently wearing silicone hydrogel contact lenses on a daily wear basis; * Currently using OPTI-FREE RepleniSH contact lens solution; * Generally healthy; * Normal ocular health; * Willing to follow study procedures and visit schedule; * Sign Informed Consent and privacy document; * Other protocol-defined inclusion criteria may apply. Exclusion Criteria: * Use of additional lens cleaners; * Known sensitivities to any ingredient in either test article; * Systemic or ocular disease or disorder that would negatively affect the conduct or outcome of the study; * History of ocular surgery/trauma within the last 6 months; * Any topical ocular or systemic antibiotics within 7 days of enrollment continuing throughout the study; * Participation in any other ophthalmic drug or device clinical trial within 30 days of enrollent; * Other protocol-defined exclusion criteria may apply.

Locations (1)

Contact Alcon Trial Center for Trial Locations

Fort Worth, Texas, United States

Outcomes

Primary Outcomes

Change From Baseline (Day 0) in Ocular Comfort Rating at Day 14

Ocular comfort was rated by the participant on a continuous visual analog scale from 0-100, where 0=extremely uncomfortable, 50=neither comfortable nor uncomfortable, and 100=extremely comfortable. The participant marked a horizontal line across the scale at the point that best described, "how your eyes feel right now." A positive number indicates increased ocular comfort; a negative number indicates decreased ocular comfort.

Time frame: Baseline (Day 0), Day 14

Data from ClinicalTrials.gov

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