Subjective Comfort With Multipurpose and Hydrogen Peroxide Lens Care Solutions in Soft Contact Lens Wearers
NCT ID: NCT01164865
Last Updated: 2012-10-12
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
78 participants
INTERVENTIONAL
2010-06-30
2010-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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OPTI-FREE RepleniSH
OPTI-FREE RepleniSH multipurpose disinfecting solution used with study contact lenses on a daily basis for 2 weeks.
OPTI-FREE RepleniSH multipurpose disinfecting solution
FDA-approved, multipurpose disinfecting solution used according to provided instructions for cleaning, rinsing, storing, and disinfecting study contact lenses on a daily basis, 2 weeks.
Contact lenses
Contact lenses per subject's habitual brand and prescription worn every day for the duration of the study, 14 days, on a daily wear basis without scheduled replacement.
Clear Care
Clear Care contact lens care system used with study contact lenses on a daily basis for 2 weeks.
Clear Care contact lens care system
FDA-approved, hydrogen peroxide-based, lens care system used according to provided instructions for cleaning, disinfecting, daily protein removing, and storage of study contact lenses on a daily basis, 2 weeks.
Contact lenses
Contact lenses per subject's habitual brand and prescription worn every day for the duration of the study, 14 days, on a daily wear basis without scheduled replacement.
Interventions
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OPTI-FREE RepleniSH multipurpose disinfecting solution
FDA-approved, multipurpose disinfecting solution used according to provided instructions for cleaning, rinsing, storing, and disinfecting study contact lenses on a daily basis, 2 weeks.
Clear Care contact lens care system
FDA-approved, hydrogen peroxide-based, lens care system used according to provided instructions for cleaning, disinfecting, daily protein removing, and storage of study contact lenses on a daily basis, 2 weeks.
Contact lenses
Contact lenses per subject's habitual brand and prescription worn every day for the duration of the study, 14 days, on a daily wear basis without scheduled replacement.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Currently using OPTI-FREE RepleniSH contact lens solution;
* Report comfort above 75 on a Visual Analog Scale at the Baseline Visit;
* Read, sign, and date IRB-approved informed consent and the privacy document;
* Be generally healthy and have normal ocular health;
* Be be willing to follow the study procedures and visit schedule;
Exclusion Criteria
* Known sensitivity to any ingredient in either of the test articles;
* Systemic or ocular disease or disorder (except refractive error) that would negatively affect the conduct or outcome of the study;
* Prior (within 7 days of enrollment) or current ocular infections;
* Clinically significant lash or lid abnormality;
* History of ocular surgery/trauma within the last 6 months;
* Use of any topical ocular or systemic antibiotics or corticosteroids within 7 days of enrollment;
* Participation in any other ophthalmic drug or device clinical trial within 30 days of enrollment;
18 Years
ALL
No
Sponsors
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Alcon Research
INDUSTRY
Responsible Party
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Countries
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Other Identifiers
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SMA-09-58
Identifier Type: -
Identifier Source: org_study_id