Lens Wearing Experience and Biocompatibility of a Multi-Purpose Disinfecting Solution (MPDS)

Alcon

Status

Completed

Conditions

Healthy

Treatments

Device: OPTI-FREE PureMoist multipurpose disinfecting solution

Study type

Interventional

Funder types

Industry

Identifiers

NCT01476722

RDG-11-149

Details and patient eligibility

About

The purpose of this study was to evaluate the efficacy of a new multipurpose disinfecting solution in silicone hydrogel and soft contact lens wearers.

Enrollment

125 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

Wear silicone hydrogel or traditional soft contact lenses on a daily wear basis, (a minimum of 8 hours per day) for at least one month prior to Visit 1;
Habitual use of a multi-purpose solution containing PHMB for at least 30 days prior to Visit 1;
Vision correctable to 20/30 (Snellen) or better in each eye at distance with pre-study lenses at Visit 1;
Read, sign, and date IRB-approved informed consent and privacy document;
Be generally healthy and have normal ocular health;
Willing to follow the study procedures and visit schedule;
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria

Wear lenses on an extended wear basis during the study;
Known sensitivity or intolerance to PHMB, POLYQUAD, or ALDOX preserved lens care products;
Monocular subject;
Requirestoric or multifocal contact lenses;
Use of additional lens care products other than a PHMB multi-purpose solution such as daily or enzyme cleaners within the one week prior to Visit 1;
Use of topical ocular over-the-counter (OTC) or prescribed topical ocular medications, with the exception of rewetting drops, within 7 days prior to Visit 1;
Any abnormal ocular condition observed during the Visit 1 Slit-lamp examination;
Ocular surgery within the 12 months prior to Visit 1;
Use of any systemic medication which has known or expected ocular or systemic side effects at Visit 1, that in the clinical judgment of the investigator, could affect the subject's participation in this study;
Any systemic disease at Visit 1 that may affect the eye or be exacerabated by use of contact lenses or contact lens solutions or which could prevent subjects from wearing their lenses at least 8 hours per day;
Participation in any clinical study within 30 days of Visit 1;
Other protocol-defined exclusion criteria may apply.