Effect of an Investigational Multi-Purpose Solution on Lens Moisture

Not Applicable

Completed

• Conditions: Contact Lens Moisture
• Interventions: Device: ReNu Fresh Lens Comfort Multi-Purpose Solution (MPS); Device: FID 114675A Multi-Purpose Disinfecting Solution (MPDS); Device: Silicone Hydrogel Contact Lenses

• Registration Number: NCT01341990
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of the study is to evaluate the effect of an investigational multi-purpose disinfecting solution (MPDS) compared to a marketed multi-purpose solution on the moisture of silicone hydrogel contact lenses.

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: 2009-11
• Study First Submitted: 2009-12-09
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Study First Submitted QC: 2011-04-25
• Study First Posted: 2011-04-26
• Status Verified: 2012-03
• Results First Submitted: 2012-03-21
• Results First Submitted QC: 2012-03-21
• Last Update Submitted: 2012-03-21
• Results First Posted: 2012-04-13
• Last Update Posted: 2012-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• 18 years of age or older.
• Wears silicone hydrogel contact lenses on a daily wear basis i.e. disinfects lenses every night).
• Has successfully worn contact lenses for 5 days, 8 hours per day, prior to baseline visit.
• Vision is correctable to 20/30 or better in each eye at distance with study lenses at baseline visit.
• Other protocol-specified inclusion criteria may apply.

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Exclusion Criteria

• Known sensitivity or intolerance to contact lens multi-purpose solutions.
• Use of any topical ocular OTC or prescribed topical ocular medications.
• History or current ocular infections or ocular inflammatory events.
• Ocular surgery within the past year.
• Medical condition or use of medication that cause ocular side effects.
• Participation in any investigational study within the past 30 days.
• Other protocol-defined exclusion criteria may apply.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ReNu MultiPlus	ReNu Fresh Lens Comfort Multi-Purpose Solution (MPS)	Multi-purpose solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
ReNu MultiPlus	Silicone Hydrogel Contact Lenses	Multi-purpose solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
FID 114675A	FID 114675A Multi-Purpose Disinfecting Solution (MPDS)	Multi-purpose disinfecting solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
FID 114675A	Silicone Hydrogel Contact Lenses	Multi-purpose disinfecting solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses

Primary Outcome Measures

Name	Time	Method
Mean Ex-Vivo Advancing Contact Angle	Day 8, 16 hours	Study lens was removed from the eye according to protocol-specified procedures. The OCA15 (Optical Contact Angle) Instrument was used to observe, record, and calculate contact angle measurements. The wetting angle measurement was recorded in degrees (0-180), and a lower wetting angle measurement indicates a more wettable lens.

Trial Locations

Locations (1)

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