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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Device: OPTI-FREE PureMoist multipurpose disinfecting solution

• Registration Number: NCT01476722
• Lead Sponsor: Alcon Research

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-06
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Study First Submitted: 2011-11-18
• Study First Submitted QC: 2011-11-21
• Study First Posted: 2011-11-22
• Results First Submitted: 2012-10-19
• Status Verified: 2012-11
• Results First Submitted QC: 2012-11-16
• Last Update Submitted: 2012-11-16
• Results First Posted: 2012-11-19
• Last Update Posted: 2012-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Corneal Fluorescein Staining Type at Baseline	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.
Corneal Fluorescein Staining Type at Day 30	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.
Corneal Fluorescein Staining Area at Baseline	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.
Corneal Fluorescein Staining Area at Day 30	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.

Trial Locations

Locations (1)

Contact Alcon Call Center for Trial Locations; 🇺🇸 Fort Worth, Texas, United States