Subjective Comfort With Multipurpose Care Solutions in Soft Contact Lens Wearers

Alcon

Status: Completed

Conditions: Myopia; Refractive Error; Astigmatism

Treatments: Device: OPTI-FREE RepleniSH multipurpose solution; Device: Silicone hydrogel contact lenses; Device: ReNu Biotrue multipurpose solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT01211535

SMA-09-59

Details and patient eligibility

About

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

Enrollment: 104 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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104 participants in 2 patient groups

OPTI-FREE RepleniSH

Experimental group

Description:

OPTI-FREE RepleniSH multipurpose solution used with study contact lenses on a daily wear basis for 14 days

Treatment:

Device: OPTI-FREE RepleniSH multipurpose solution

Device: Silicone hydrogel contact lenses

ReNu Biotrue

Active Comparator group

Description:

ReNu Biotrue multipurpose solution used with study contact lenses on a daily wear basis for 14 days

Treatment:

Device: ReNu Biotrue multipurpose solution

Device: Silicone hydrogel contact lenses