Safety and Efficacy of an Investigational Multi-Purpose Disinfecting Solution

Not Applicable

Completed

• Conditions: Healthy Contact Lens Wearers
• Interventions: Device: Alcon MPDS; Device: ReNu Fresh MPS

• Registration Number: NCT01341977
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study is to determine if Alcon MPDS is safe and effective for silicone hydrogel and soft hydrogel contact lens wearers.

Detailed Description

The purpose of this study is to determine if Alcon Multi-Purpose Disinfecting Solution (MPDS) is safe and effective for silicone hydrogel and soft hydrogel contact lens wearers.

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: 2010-05
• Study Completion: 2010-05
• Study First Submitted QC: 2011-04-25
• Study First Posted: 2011-04-26
• Status Verified: 2011-09
• Results First Submitted: 2011-09-08
• Results First Submitted QC: 2011-09-08
• Results First Posted: 2011-10-13
• Last Update Submitted: 2020-09-01
• Last Update Posted: 2020-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 573

Inclusion Criteria

• Silicone hydrogel or soft contact lens wearers who wear their lenses daily wear (i.e. disinfect lenses every night).
• Patient must be able to read.
• Vision correctable to 20/30 or better with contact lenses.

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Exclusion Criteria

• Sensitivity to multi-purpose solutions.
• Using any topical ocular OTC or prescribed topical ocular medications.
• History or current ocular infections or ocular inflammatory events.
• Ocular surgery within the past year.
• With a medical condition or using medications that cause ocular side effects.
• Participation in any investigational study within the past 30 days.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alcon MPDS	Alcon MPDS	Alcon Multi-Purpose Disinfecting Solution (MPDS)
ReNu Fresh Multi-Purpose Solution	ReNu Fresh MPS	ReNu Fresh Multi-Purpose Solution

Primary Outcome Measures

Name	Time	Method
Subjective Acceptance	Day 90	Lens Moisture Subject Rated Likert Item (1-Strongly Agree to 5-Strongly Disagree)

Trial Locations

Locations (1)

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