Evaluation of Marketed Contact Lens Disinfectant Systems on Eyelid Tissues

Alcon

Status: Completed

Conditions: Contact Lens Care

Treatments: Device: Soft contact lenses; Device: Hydrogen peroxide-based contact lens care system; Device: PHMB-containing contact lens solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT01494818

ID 10-59 / M-11-02

Details and patient eligibility

About

The purpose of this study was to assess and compare the effect of the repeated usage of two different contact lens care systems (one hydrogen peroxide-based cleaning and disinfecting system, and one polyaminopropyl biguanide (PHMB)-containing multipurpose system) with silicone hydrogel contact lenses worn on a daily wear basis for three months. The specific aspect of interest was the effect on the ocular tissue, in particular the eyelids and their associations with the contact lens surface wettability and surface contamination.

Full description

The subjects attended the enrollment visit having worn their habitual silicone hydrogel contact lenses for at least six hours on the day of the visit. The enrollment visit was scheduled so that the subjects' habitual lenses were at least 14 ± 3 days old for the subjects replacing their lenses bi-weekly and at least 30 ± 5 days old for those replacing their lenses monthly.

Enrollment: 79 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Read and understand Participant Information Sheet;
• Read, sign, and date Informed Consent;
• Successfully wearing silicone hydrogel contact lenses under a frequent replacement (biweekly or monthly) daily wear modality;
• Using a PHMB-containing multipurpose contact lens solution;
• Symptomatic, as specified in protocol;
• Best corrected visual acuity of 6/9 or better in each eye;
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Any known sensitivity or intolerance to the contact lenses or len care products to be used;
• Systemic disease/medication which might interfere with contact lens wear or produce dry eye side effects;
• Ocular allergies or ocular disease which might interfere with contact lens wear;
• Use of any concomitant topical ocular medications during the study period;
• Participation in an investigational drug or device study within 30 days of entering the study;
• Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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79 participants in 2 patient groups

CLEAR CARE/AOSEPT Plus

Experimental group

Description:

Hydrogen peroxide-based contact lens care system used per manufacturer's instructions

Treatment:

Device: Hydrogen peroxide-based contact lens care system

Device: Soft contact lenses

ReNu MultiPlus

Active Comparator group

Description:

PHMB-containing contact lens solution used per manufacturer's instructions

Treatment:

Device: PHMB-containing contact lens solution

Device: Soft contact lenses