Acute Clinical Evaluation of Multi-purpose Solutions (MPS) in Soft Contact Lens Wearers
NCT ID: NCT00929487
Last Updated: 2012-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
278 participants
INTERVENTIONAL
2009-05-31
2012-05-31
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
CROSSOVER
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Contact lens solution #1
Contact lens multi-purpose solution
Lens care solutions CE-marked for intended use. A fresh pair of contact lenses was soaked overnight in the test contact lens solution and a pre-cycled lens case prior to study visit, then worn for two hours on the day of the study visit. Up to four solutions were evaluated in randomized order with the same brand of contact lenses, and a minimum of 12 hours of no lens wear separated each wear period.
Contact lenses
CE-marked silicone hydrogel contact lenses soaked overnight for at least 10 hours prior to the study visit, then worn for two hours on the day of the study visit. A fresh pair of the same brand of contact lenses was used for each overnight soak (ie, 4 solutions plus saline/blister pack solution), and a minimum of 12 hours separated each wear period.
Contact lens solution #2
Contact lens multi-purpose solution
Lens care solutions CE-marked for intended use. A fresh pair of contact lenses was soaked overnight in the test contact lens solution and a pre-cycled lens case prior to study visit, then worn for two hours on the day of the study visit. Up to four solutions were evaluated in randomized order with the same brand of contact lenses, and a minimum of 12 hours of no lens wear separated each wear period.
Contact lenses
CE-marked silicone hydrogel contact lenses soaked overnight for at least 10 hours prior to the study visit, then worn for two hours on the day of the study visit. A fresh pair of the same brand of contact lenses was used for each overnight soak (ie, 4 solutions plus saline/blister pack solution), and a minimum of 12 hours separated each wear period.
Contact lens solution #3
Contact lens multi-purpose solution
Lens care solutions CE-marked for intended use. A fresh pair of contact lenses was soaked overnight in the test contact lens solution and a pre-cycled lens case prior to study visit, then worn for two hours on the day of the study visit. Up to four solutions were evaluated in randomized order with the same brand of contact lenses, and a minimum of 12 hours of no lens wear separated each wear period.
Contact lenses
CE-marked silicone hydrogel contact lenses soaked overnight for at least 10 hours prior to the study visit, then worn for two hours on the day of the study visit. A fresh pair of the same brand of contact lenses was used for each overnight soak (ie, 4 solutions plus saline/blister pack solution), and a minimum of 12 hours separated each wear period.
Contact lens solution #4
Contact lens multi-purpose solution
Lens care solutions CE-marked for intended use. A fresh pair of contact lenses was soaked overnight in the test contact lens solution and a pre-cycled lens case prior to study visit, then worn for two hours on the day of the study visit. Up to four solutions were evaluated in randomized order with the same brand of contact lenses, and a minimum of 12 hours of no lens wear separated each wear period.
Contact lenses
CE-marked silicone hydrogel contact lenses soaked overnight for at least 10 hours prior to the study visit, then worn for two hours on the day of the study visit. A fresh pair of the same brand of contact lenses was used for each overnight soak (ie, 4 solutions plus saline/blister pack solution), and a minimum of 12 hours separated each wear period.
Saline/blister pack solution
Saline/blister pack solution
A fresh pair of contact lenses was soaked overnight in saline prior to study visit or was inserted directly from the blister pack, then worn for two hours on the day of the study visit.
Contact lenses
CE-marked silicone hydrogel contact lenses soaked overnight for at least 10 hours prior to the study visit, then worn for two hours on the day of the study visit. A fresh pair of the same brand of contact lenses was used for each overnight soak (ie, 4 solutions plus saline/blister pack solution), and a minimum of 12 hours separated each wear period.
Interventions
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Contact lens multi-purpose solution
Lens care solutions CE-marked for intended use. A fresh pair of contact lenses was soaked overnight in the test contact lens solution and a pre-cycled lens case prior to study visit, then worn for two hours on the day of the study visit. Up to four solutions were evaluated in randomized order with the same brand of contact lenses, and a minimum of 12 hours of no lens wear separated each wear period.
Saline/blister pack solution
A fresh pair of contact lenses was soaked overnight in saline prior to study visit or was inserted directly from the blister pack, then worn for two hours on the day of the study visit.
Contact lenses
CE-marked silicone hydrogel contact lenses soaked overnight for at least 10 hours prior to the study visit, then worn for two hours on the day of the study visit. A fresh pair of the same brand of contact lenses was used for each overnight soak (ie, 4 solutions plus saline/blister pack solution), and a minimum of 12 hours separated each wear period.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Be an adapted and successful soft contact lens wearer on a daily wear basis for at least two weeks.
* Vision correctable to at least 20/30 Snellen.
Exclusion Criteria
* History of hypersensitivity to any component of the study contact lens care systems.
* Any slit-lamp finding of abnormal nature at the baseline visit assessment of each study period.
* Pregnant, lactating, or planning a pregnancy.
18 Years
ALL
No
Sponsors
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Alcon Research
INDUSTRY
Responsible Party
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Locations
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Visioncare Research, Ltd.
Farnham, Surrey, United Kingdom
Countries
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References
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Malet F. An acute clinical comparison of corneal staining and comfort associated with contact lens care solutions. Cont Lens Anterior Eye. 2014 Oct;37(5):351-7. doi: 10.1016/j.clae.2014.05.007. Epub 2014 Jul 26.
Other Identifiers
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SMA-09-14/RDG-11-152
Identifier Type: -
Identifier Source: org_study_id