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

Information source: Alcon Research
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: OPTI-FREE PureMoist multipurpose disinfecting solution (Device)

Phase: N/A

Status: Completed

Sponsored by: Alcon Research

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.

Clinical Details

Official title: Lens Wearing Experience and Biocompatibility With OPTI-FREE® PureMoist® Multi-Purpose Disinfecting Solution (OFP MPDS) in Silicone Hydrogel and Soft Contact Lens Wearers (US)

Study design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Primary outcome:

Corneal Fluorescein Staining Type at Baseline

Corneal Fluorescein Staining Type at Day 30

Corneal Fluorescein Staining Area at Baseline

Corneal Fluorescein Staining Area at Day 30

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Contact Alcon Call Center for Trial Locations, Fort Worth, Texas 76314, United States
Additional Information

Starting date: June 2011
Last updated: November 16, 2012

Page last updated: August 20, 2015

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