Alcon Multi-Purpose Disinfecting Solution Versus Renu Fresh Multi-Purpose Solution in Symptomatic Contact Lens Wearers

Not Applicable

Completed

• Conditions: Symptomatic Contact Lens Wearers
• Interventions: Device: FID 114675A Multi-Purpose Disinfecting Solution (MPDS); Device: renu fresh Multi-Purpose Solution (MPS); Device: Contact lenses

• Registration Number: NCT01187355
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study is to compare two contact lens care solutions in symptomatic wearers 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: 2010-07
• Study First Submitted: 2010-08-20
• Study First Submitted QC: 2010-08-23
• Study First Posted: 2010-08-24
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2012-06
• Results First Submitted: 2012-06-26
• Results First Submitted QC: 2012-06-26
• Last Update Submitted: 2012-06-26
• Results First Posted: 2012-07-30
• Last Update Posted: 2012-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 591

Inclusion Criteria

• Symptomatic silicone hydrogel contact lens wearers who wear their lenses daily wear (i.e., disinfect lenses every night).
• Vision correctable to 20/30 or better with contact lenses.
• Other protocol-defined inclusion criteria may apply.

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Exclusion Criteria

• Sensitivity to multi-purpose solutions.
• Use of any topical ocular OTC or prescribed topical ocular medications.
• History (6 months) or current ocular infections or ocular inflammatory events.
• Ocular surgery within the past year.
• Medical condition or use of medications 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
Alcon MPDS	FID 114675A Multi-Purpose Disinfecting Solution (MPDS)	MPDS used for 30 days as specified in protocol for contact lens care.
Alcon MPDS	Contact lenses	MPDS used for 30 days as specified in protocol for contact lens care.
renu fresh MPS	renu fresh Multi-Purpose Solution (MPS)	MPS used for 30 days as indicated for contact lens care.
renu fresh MPS	Contact lenses	MPS used for 30 days as indicated for contact lens care.

Primary Outcome Measures

Name	Time	Method
Likert Statement: When I Use This Solution, I Can Comfortably Wear my Lenses.	Day 30	As interpreted and reported by the subject on a questionnaire as a single, retrospective evaluation of the last three days of wearing experience. A 5-point Likert scale was used, where 1=strongly disagree, 2=disagree; 3=neither disagree nor agree; 4=agree; 5=strongly agree.

Secondary Outcome Measures

Name	Time	Method
Likert Statement: When I Use This Solution, My Lenses Are Comfortable From Morning Until Evening.	Day 30	As interpreted and reported by the subject on a questionnaire as a single, retrospective evaluation of the last three days of wearing experience. A 5-point Likert scale was used, where 1=strongly disagree, 2=disagree; 3=neither disagree nor agree; 4=agree; 5=strongly agree.
Likert Statement: When I Use This Solution, I Forget I am Wearing my Lenses.	Day 30	As interpreted and reported by the subject on a questionnaire as a single, retrospective evaluation of the last three days of wearing experience. A 5-point Likert scale was used, where 1=strongly disagree, 2=disagree; 3=neither disagree nor agree; 4=agree; 5=strongly agree.

Trial Locations

Locations (1)

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