Clinical Performance of a Silicone Hydrogel Lens With Use of FID 114675A
NCT ID: NCT01240135
Last Updated: 2012-07-12
Study Results
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View full resultsBasic Information
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COMPLETED
NA
89 participants
INTERVENTIONAL
2010-10-31
2011-02-28
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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FID 114576A / renu fresh
FID 114675A used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after which renu fresh used for contact lens care for an additional 14 days.
FID 114675A multi-purpose disinfecting solution (MPDS)
Daily regimen, 14 days: Thoroughly wet and rub each side of study contact lens for 10 seconds, rinse each side of the lens for 10 seconds, and soak contact lens for at least 6 hours.
renu fresh Multi-Purpose Solution (MPS)
Daily regimen, 14 days: Wet study contact lens with 3 drops and rub each side of the lens for 20 seconds, rinse each side of the lens for 5 seconds, and soak contact lens for at least 4 hours.
Galyfilcon A contact lenses (Acuvue Advance)
A fresh pair of contact lenses matching subject's pre-study lenses, including parameters, dispensed at the beginning of each period for daily wear, minimum 8 hours per day, 14 days.
renu fresh / FID 114675A
Renu fresh used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after FID 114675A used for contact lens care for an additional 14 days.
FID 114675A multi-purpose disinfecting solution (MPDS)
Daily regimen, 14 days: Thoroughly wet and rub each side of study contact lens for 10 seconds, rinse each side of the lens for 10 seconds, and soak contact lens for at least 6 hours.
renu fresh Multi-Purpose Solution (MPS)
Daily regimen, 14 days: Wet study contact lens with 3 drops and rub each side of the lens for 20 seconds, rinse each side of the lens for 5 seconds, and soak contact lens for at least 4 hours.
Galyfilcon A contact lenses (Acuvue Advance)
A fresh pair of contact lenses matching subject's pre-study lenses, including parameters, dispensed at the beginning of each period for daily wear, minimum 8 hours per day, 14 days.
Interventions
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FID 114675A multi-purpose disinfecting solution (MPDS)
Daily regimen, 14 days: Thoroughly wet and rub each side of study contact lens for 10 seconds, rinse each side of the lens for 10 seconds, and soak contact lens for at least 6 hours.
renu fresh Multi-Purpose Solution (MPS)
Daily regimen, 14 days: Wet study contact lens with 3 drops and rub each side of the lens for 20 seconds, rinse each side of the lens for 5 seconds, and soak contact lens for at least 4 hours.
Galyfilcon A contact lenses (Acuvue Advance)
A fresh pair of contact lenses matching subject's pre-study lenses, including parameters, dispensed at the beginning of each period for daily wear, minimum 8 hours per day, 14 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* History of at least 5 days successful daily wear (minimum 8 hours per day) of spherical, single power Acuvue® Advance® SiH contact lenses prior to Visit 1.
* Wear contact lenses a minimum of 8 hours per day prior to Visit 1.
* Vision correctable to 20/30 (Snellen) or better in each eye at distance with study lenses at Visit 1.
Exclusion Criteria
* Use of products other than a multi-purpose solution to care for lenses at least 7 days prior to Visit 1. Pre-study use of rewetting drops is acceptable.
* History of intolerance or known sensitivity to any component of the treatments.
* Use of over-the-counter (OTC) or prescribed topical ocular medications within 7 days prior to Visit 1.
18 Years
ALL
No
Sponsors
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Alcon Research
INDUSTRY
Responsible Party
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Other Identifiers
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C-10-030
Identifier Type: -
Identifier Source: org_study_id