Subjective Comfort With Multipurpose and Hydrogen Peroxide Lens Care Solutions in Soft Contact Lens Wearers

Alcon

Status: Completed

Conditions: Contact Lens Wear

Treatments: Device: Clear Care contact lens care system; Device: Contact lenses; Device: OPTI-FREE RepleniSH multipurpose disinfecting solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT01164865

SMA-09-58

Details and patient eligibility

About

The purpose of this study was to assess comfort in soft contact lens wearers.

Enrollment: 78 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Wear silicone hydrogel contact lenses on a daily wear basis;
• Currently using OPTI-FREE RepleniSH contact lens solution;
• Report comfort above 75 on a Visual Analog Scale at the Baseline Visit;
• Read, sign, and date IRB-approved informed consent and the privacy document;
• Be generally healthy and have normal ocular health;
• Be be willing to follow the study procedures and visit schedule;
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Use of additional lens cleaners;
• Known sensitivity to any ingredient in either of the test articles;
• Systemic or ocular disease or disorder (except refractive error) that would negatively affect the conduct or outcome of the study;
• Prior (within 7 days of enrollment) or current ocular infections;
• Clinically significant lash or lid abnormality;
• History of ocular surgery/trauma within the last 6 months;
• Use of any topical ocular or systemic antibiotics or corticosteroids within 7 days of enrollment;
• Participation in any other ophthalmic drug or device clinical trial within 30 days of enrollment;
• 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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78 participants in 2 patient groups

OPTI-FREE RepleniSH

Experimental group

Description:

OPTI-FREE RepleniSH multipurpose disinfecting solution used with study contact lenses on a daily basis for 2 weeks.

Treatment:

Device: OPTI-FREE RepleniSH multipurpose disinfecting solution

Device: Contact lenses

Clear Care

Active Comparator group

Description:

Clear Care contact lens care system used with study contact lenses on a daily basis for 2 weeks.

Treatment:

Device: Contact lenses

Device: Clear Care contact lens care system