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

NCT ID: NCT01476722

Last Updated: 2012-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2011-10-31

Brief Summary

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

Conditions

Healthy

Keywords

Silicone Hydrogel; Soft Contact Lenses; Multi-Purpose Solution

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

OPTI-FREE PureMoist

OPTI-FREE PureMoist multipurpose disinfecting solution used with study contact lenses on a daily wear basis for 30 days

Group Type: EXPERIMENTAL

OPTI-FREE PureMoist multipurpose disinfecting solution

Intervention Type: DEVICE

FDA-approved, multipurpose disinfecting solution used as indicated for cleaning, rinsing, reconditioning, disinfecting, and storing silicone hydrogel and soft contact lenses on a daily wear basis for 30 days

Interventions

OPTI-FREE PureMoist multipurpose disinfecting solution

FDA-approved, multipurpose disinfecting solution used as indicated for cleaning, rinsing, reconditioning, disinfecting, and storing silicone hydrogel and soft contact lenses on a daily wear basis for 30 days

Intervention Type: DEVICE

Eligibility 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;

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, United States

Countries

United States

Other Identifiers

RDG-11-149

Identifier Type: -

Identifier Source: org_study_id