Lens Wearing Experience and Biocompatibility of a Marketed Multi-Purpose Disinfecting Solution in Silicone Hydrogel and Soft Contact Lens Wearers

Not Applicable

Completed

• Conditions: Refractive Error
• Interventions: Device: OPTI-FREE PureMoist

• Registration Number: NCT01484938
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study was to describe mean differences in corneal staining (type and area) for OPTI-FREE PureMoist Multi-Purpose Disinfecting Solution (MPDS) at Day 30 compared to Baseline (Day 0).

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: 2011-02
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Study First Submitted: 2011-12-01
• Study First Submitted QC: 2011-12-01
• Study First Posted: 2011-12-05
• Results First Submitted: 2012-09-06
• Results First Submitted QC: 2012-09-06
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-05
• Results First Posted: 2012-10-08
• Last Update Posted: 2012-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 175

Inclusion Criteria

• 18 years or older
• Soft contact lens wear on a daily wear basis
• Able to wear contact lenses for at least 8 hours
• Generally healthy and have normal ocular health
• Other protocol-defined inclusion criteria may apply

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Exclusion Criteria

• No use of additional lens cleaners
• No known sensitivities to any ingredient in the test article
• No history of ocular surgery/trauma within the last six months
• Other protocol-defined exclusion criteria may apply

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OPTI-FREE	OPTI-FREE PureMoist	OPTI-FREE PureMoist multi-purpose contact lens solution used for cleaning, rinsing, disinfecting/storing, and reinserting contact lenses, per protocol-specified regimen

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline (Day 0) in Average Corneal Staining Area at Day 30	Baseline (Day 0), Day 30	Percentage corneal staining was assessed by the investigator for each of five regions of the cornea; i.e., four quadrants plus central. The investigator instilled flourescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and yellow filter. Percentage corneal staining was recorded in increments of ten, and the percentages of the five regions were averaged together.
Mean Change From Baseline (Day 0) in Total Corneal Staining Type at Day 30	Baseline (Day 0), Day 30	Corneal staining type was assessed by the investigator for each of five regions of the cornea, i.e., four quadrants plus central. The investigator instilled flourescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and 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 (\>/= 1 mm). The five regions were summed, for a summed total range of 0-20.

Trial Locations

Locations (1)

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