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

• ClinicalTrials.gov Identifier: NCT01476722
• Recruitment Status: Completed
• First Posted: November 22, 2011
• Results First Posted: November 19, 2012
• Last Update Posted: November 19, 2012
• Sponsor: Alcon Research
• Information provided by (Responsible Party): Alcon Research

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Healthy	Device: OPTI-FREE PureMoist multipurpose disinfecting solution	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 125 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Participant)
• Primary Purpose: Supportive Care
• 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 Start Date: June 2011
• Actual Primary Completion Date: October 2011
• Actual Study Completion Date: October 2011

Arms and Interventions

Arm	Intervention/treatment
Experimental: OPTI-FREE PureMoist; OPTI-FREE PureMoist multipurpose disinfecting solution used with study contact lenses on a daily wear basis for 30 days	Device: 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

Outcome Measures

Primary Outcome Measures :

1. Corneal Fluorescein Staining Type at Baseline [ Time Frame: Day 0 (Baseline) ]
   Corneal staining type was assessed by the investigator for each of 5 regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. Corneal staining type was recorded on a 5-point scale for each region: 0-none; 1-micropunctate; 2-macropunctate; 3-coalesced macropunctate; 4-patch (>/= 1mm). The five regions were summed, for a maximum score of 20. A lower score represents a more desirable outcome.
2. Corneal Fluorescein Staining Type at Day 30 [ Time Frame: Day 30 ]
   Corneal staining type was assessed by the investigator for each of 5 regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. Corneal staining type was recorded on a 5-point scale for each region: 0-none; 1-micropunctate; 2-macropunctate; 3-coalesced macropunctate; 4-patch (>/= 1mm). The five regions were summed, for a maximum score of 20. A lower score represents a more desirable outcome.
3. Corneal Fluorescein Staining Area at Baseline [ Time Frame: Day 0 (Baseline) ]
   Corneal staining was assessed by the investigator for each of five regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. The area (extent) of corneal staining for each of the five areas was estimated [i.e., 0% (no staining in the region) to 100% (staining covers entire region)], for a maximum score of 100% per eye. A lower score represents a more desirable outcome.
4. Corneal Fluorescein Staining Area at Day 30 [ Time Frame: Day 30 ]
   Corneal staining was assessed by the investigator for each of five regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. The area (extent) of corneal staining for each of the five areas was estimated [i.e., 0% (no staining in the region) to 100% (staining covers entire region)], for a maximum score of 100% per eye. A lower score represents a more desirable outcome.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Texas

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, United States, 76314

Sponsors and Collaborators

Alcon Research

More Information

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT01476722
• Other Study ID Numbers: RDG-11-149
• First Posted: November 22, 2011
• Results First Posted: November 19, 2012
• Last Update Posted: November 19, 2012
• Last Verified: November 2012

Keywords provided by Alcon Research:

Silicone Hydrogel; Soft Contact Lenses; Multi-Purpose Solution