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

Alcon

Status: Completed

Conditions: Refractive Error

Treatments: Device: Hydrogen peroxide-based contact lens solution; Device: Habitual contact lens solution; Device: Habitual contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT01996709

A01337

Details and patient eligibility

About

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

Enrollment: 142 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.
• Other protocol-specified inclusion criteria may apply.

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.
• Other protocol-specified exclusion criteria may apply.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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142 participants in 2 patient groups

Clear Care

Experimental group

Description:

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

Treatment:

Device: Habitual contact lenses

Device: Hydrogen peroxide-based contact lens solution

Habitual MPS

Active Comparator group

Description:

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

Treatment:

Device: Habitual contact lenses

Device: Habitual contact lens solution