Comparison of Somofilcon A Daily Disposable Test Contact Lens and Somofilcon A Daily Disposable Control Contact Lens
NCT ID: NCT03372551
Last Updated: 2019-07-23
Study Results
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View full resultsBasic Information
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COMPLETED
NA
36 participants
INTERVENTIONAL
2017-11-29
2018-04-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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somofilcon A 1 day test lens
Subjects wearing the somofilcon A 1 day test lens for one week, either randomized as the first or second pair.
somofilcon A 1 day test lens
Contact lens
somofilcon A 1 day control lens
Contact lens
somofilcon A 1 day control lens
Subjects wearing the somofilcon A 1 day control lens for one week, either randomized as the first or second pair.
somofilcon A 1 day test lens
Contact lens
somofilcon A 1 day control lens
Contact lens
Interventions
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somofilcon A 1 day test lens
Contact lens
somofilcon A 1 day control lens
Contact lens
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has had a self-reported oculo-visual examination in the last two years;
* Has read, understood, and signed the information consent letter;
* Is willing and able to follow instructions and maintain the appointment schedule;
* Has a visual acuity of 20/30 or better (in each eye) with their habitual vision correction, or 20/20 best-corrected vision (for binocular distance acuity);
* Must be able to achieve 20/30 or better (in each eye) with the study lenses;
* Currently wears soft contact lenses for at least 3 days per week, 8 hours each day;
* Requires spectacle lens powers between -0.75 and -06.50 diopters sphere (0.25D steps);
* Has no more than 0.75 diopters of refractive astigmatism;
* Has clear corneas and no active\* ocular disease;
* Has not worn lenses for at least 12 hours before the examination.
Exclusion Criteria
* Has never worn contact lenses before.
* Has any systemic disease affecting ocular health.
* Has any active\* ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
* Is using any systemic or topical medications that will affect a study outcome variable, and/or ocular health.
* Has any known sensitivity to fluorescein dye or products to be used in the study.
* Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
* Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
* Is aphakic.
* Has undergone corneal refractive surgery.
* Is pregnant, lactating, or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit).
17 Years
ALL
No
Sponsors
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CooperVision, Inc.
INDUSTRY
Responsible Party
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Locations
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Center for Contact Lens Research, University of Waterloo
Waterloo, Ontario, Canada
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CV-16-43
Identifier Type: -
Identifier Source: org_study_id
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