Effectiveness of a Marketed One-Step Peroxide Lens Care Solution in Symptomatic Contact Lens Wearers

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2014-05-31

Brief Summary

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The purpose of this study is to assess improvement of palpebral roughness and associated symptoms with 3 months use of Clear Care®.

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Detailed Description

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Conditions

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Refractive Error

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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Clear Care

Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days

Group Type EXPERIMENTAL

Hydrogen peroxide-based contact lens solution

Intervention Type DEVICE

Habitual contact lenses

Intervention Type DEVICE

Silicone hydrogel contact lenses with a biweekly or monthly replacement schedule

Habitual MPS

Habitual contact lens solution used with habitual contact lenses for 90 days

Group Type ACTIVE_COMPARATOR

Habitual contact lens solution

Intervention Type DEVICE

Biguanide-preserved

Habitual contact lenses

Intervention Type DEVICE

Silicone hydrogel contact lenses with a biweekly or monthly replacement schedule

Interventions

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Hydrogen peroxide-based contact lens solution

Intervention Type DEVICE

Habitual contact lens solution

Biguanide-preserved

Intervention Type DEVICE

Habitual contact lenses

Silicone hydrogel contact lenses with a biweekly or monthly replacement schedule

Intervention Type DEVICE

Other Intervention Names

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Clear Care®

Eligibility Criteria

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Inclusion Criteria

* Current biweekly or monthly silicone hydrogel contact lens wearer (excluding Air Optix® brand) and have worn these lenses bilaterally for at least three (3) months prior to Visit 1 (daily wear use only).
* Symptoms of contact lens discomfort as defined by the protocol.
* Habitual use of a biguanide-preserved multi-purpose solution for at least 30 days prior to Visit 1.
* Mild to severe (grade 2-4) Investigator rated palpebral roughness in one or more zones of either eye.

Exclusion Criteria

* Extended (over-night) contact lens wearer.
* Any systemic or ocular disease or disorder (refractive disorder allowed and mild dry eye with successful contact lens wear is permitted), complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study.
* Topical ocular over the counter (OTC) or prescribed medications, with the exception of contact lens rewetting drops, within 7 days of enrollment.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No