A Clinical Comparison of Three Contact Lens Care Systems and Their Effect on Contact Lenses
NCT ID: NCT00982046
Last Updated: 2016-11-16
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
75 participants
INTERVENTIONAL
2009-04-30
2010-05-31
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
SINGLE
Study Groups
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ACUVUE OASYS
Acuvue Oasys contact lenses worn on a daily wear basis and cleaned nightly with one of three contact lens care solutions. Each solution was used for 2 weeks, and the order in which the solutions were used was randomized. A fresh pair of lenses was dispensed with each solution. Total duration of contact lens wear was six weeks.
Opti-Free RepleniSH multi-purpose disinfecting solution
Contact lens solution CE-marked for intended use.
ReNu MultiPlus multi-purpose solution
Contact lens solution CE-marked for intended use.
Clear Care cleaning and disinfecting system
Contact lens care system CE-marked for intended use.
Senofilcon A contact lens (ACUVUE OASYS)
Silicone hydrogel contact lens worn for two weeks on a daily wear basis and cleaned nightly with one of three contact lens care solutions. The order of solutions was randomized, and a fresh pair of lenses was dispensed with each solution.
AIR OPTIX AQUA
Air Optix Aqua contact lenses worn on a daily wear basis and cleaned nightly with one of three contact lens care solutions. Each solution was used for 2 weeks, and the order in which the solutions were used was randomized. A fresh pair of lenses was dispensed with each solution. Total duration of contact lens wear was six weeks.
Opti-Free RepleniSH multi-purpose disinfecting solution
Contact lens solution CE-marked for intended use.
ReNu MultiPlus multi-purpose solution
Contact lens solution CE-marked for intended use.
Clear Care cleaning and disinfecting system
Contact lens care system CE-marked for intended use.
Lotrafilcon B contact lens (AIR OPTIX AQUA)
Silicone hydrogel contact lens worn for two weeks on a daily wear basis and cleaned nightly with one of three contact lens care solutions. The order of solutions was randomized, and a fresh pair of lenses was dispensed with each solution.
Biofinity
Biofinity contact lenses worn on a daily wear basis and cleaned nightly with one of three contact lens care solutions. Each solution was used for 2 weeks, and the order in which the solutions were used was randomized. A fresh pair of lenses was dispensed with each solution. Total duration of contact lens wear was six weeks.
Opti-Free RepleniSH multi-purpose disinfecting solution
Contact lens solution CE-marked for intended use.
ReNu MultiPlus multi-purpose solution
Contact lens solution CE-marked for intended use.
Clear Care cleaning and disinfecting system
Contact lens care system CE-marked for intended use.
Comfilcon A contact lens (Biofinity)
Silicone hydrogel contact lens worn for two weeks on a daily wear basis and cleaned nightly with one of three contact lens care solutions. The order of solutions was randomized, and a fresh pair of lenses was dispensed with each solution.
Interventions
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Opti-Free RepleniSH multi-purpose disinfecting solution
Contact lens solution CE-marked for intended use.
ReNu MultiPlus multi-purpose solution
Contact lens solution CE-marked for intended use.
Clear Care cleaning and disinfecting system
Contact lens care system CE-marked for intended use.
Senofilcon A contact lens (ACUVUE OASYS)
Silicone hydrogel contact lens worn for two weeks on a daily wear basis and cleaned nightly with one of three contact lens care solutions. The order of solutions was randomized, and a fresh pair of lenses was dispensed with each solution.
Lotrafilcon B contact lens (AIR OPTIX AQUA)
Silicone hydrogel contact lens worn for two weeks on a daily wear basis and cleaned nightly with one of three contact lens care solutions. The order of solutions was randomized, and a fresh pair of lenses was dispensed with each solution.
Comfilcon A contact lens (Biofinity)
Silicone hydrogel contact lens worn for two weeks on a daily wear basis and cleaned nightly with one of three contact lens care solutions. The order of solutions was randomized, and a fresh pair of lenses was dispensed with each solution.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Adapted contact lens wearer for at least one month.
* Spherical prescription range between +6.00 to -8.00 diopters.
* Astigmatism of less than or equal to 1.00 diopter in at least one eye.
* Normal eyes with no evidence of abnormality or disease.
Exclusion Criteria
* Concurrent ocular medication, systemic illness, or medical treatment that will affect ocular physiology, lens performance, or vision.
* Corneal infiltrates, scarring, or neovascularization within central 4 millimeters of cornea.
* Eye injury or surgery within 8 weeks prior to study.
* Aphakia, amblyopia, abnormal lacrimal secretions, ocular irritation, keratoconus, corneal irregularity, pregnancy, lactating, planning to become pregnant during the study, and participation in a concurrent clinical trial.
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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Program No 105358. Hall LA, Garofalo R, Young G. Clinical comparison of three contact lens systems in conjunction with senofilcon A, lotrafilcon B and comfilcon A daily wear lenses. American Academy of Optometry 2010.
Other Identifiers
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M-09-05
Identifier Type: -
Identifier Source: org_study_id