Comparison of a New Abbott Medical Optics (AMO) Multi-Purpose Solution (MPS) to Existing Contact Lens Regimens
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|ClinicalTrials.gov Identifier: NCT01294917|
Recruitment Status : Completed
First Posted : February 14, 2011
Results First Posted : May 14, 2012
Last Update Posted : March 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Normal Contact Lens Wearers||Device: Multi-purpose disinfecting solution Device: Clear Care Device: Opti-Free RepleniSH||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||Comparison of a New AMO MPS to Existing Contact Lens Regimens|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||August 2011|
Experimental: Investigational MPS
AMO Investigational MPS.
Device: Multi-purpose disinfecting solution
For the cleaning, rinsing, and storage of soft contact lenses.
Active Comparator: Clear Care
Peroxide-based lens care regimen.
Device: Clear Care
Peroxide-based regimen for cleaning and disinfecting soft contact lenses.
Active Comparator: Opti-Free RepleniSH
Multi-purpose disinfecting solution (Alcon).
Device: Opti-Free RepleniSH
Multi-purpose disinfecting solution for the cleaning, rinsing and storing of soft contact lenses.
- Corneal Staining [ Time Frame: 4 weeks ]Corneal staining will be assessed with sodium fluorescein dye on the ocular surface. The cornea is split into 5 sections, each section is evaluated by staining type, depth, and extent is graded on a 0 to 100 scale with higher scores indicating more staining. The possible total range for the total score per eye is 0 to 50,000 (100x100x100=10,000 per section) with values higher than 1200 being clinically relevant.
- Subjective Lens Wearing Comfort [ Time Frame: 4 weeks ]This will be assessed by a questionnaire on patient-perceived lens comfort and any symptoms of discomfort on a 0 to 100 scale.
- Dryness [ Time Frame: 4 weeks ]This will be assessed by the tear break-up time on the lens surface, measured in seconds.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01294917
|Centre for Contact Lens Research|
|Waterloo, Ontario, Canada, N2L 3G1|
|Principal Investigator:||Craig Woods, MOptom||University of Waterloo|