A Dispensing Clinical Trial of Test Contact Lens Against Marketed Contact Lens
NCT ID: NCT03499067
Last Updated: 2020-08-26
Study Results
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View full resultsBasic Information
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COMPLETED
58 participants
INTERVENTIONAL
2018-04-11
2018-08-01
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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Test lens
Subjects wearing the test contact lens either as first or second pair during the cross-over study.
Test lens
Contact lens
Control lens
Contact lens
Control lens
Subjects wearing the control contact lens either as first or second pair during the cross-over study.
Test lens
Contact lens
Control lens
Contact lens
Interventions
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Test lens
Contact lens
Control lens
Contact lens
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Is at least 18 years of age and has full legal capacity to volunteer.
* Has read and understood the information consent letter.
* Is willing and able to follow instructions and maintain the appointment schedule.
* Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.
* Currently wears soft contact lenses.
* Requires spectacle lens powers between -0.75 to -6.50 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.
* Has a usable pair of spectacle lenses if required for transportation to the site for the initial visit
Exclusion Criteria
* Has any systemic disease affecting ocular health.
* Is using any systemic or topical medications that will affect ocular health.
* Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
* 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 participating in any other type of eye related clinical or research study.
* Known allergy to a product used in this study (ex. Shellfish allergy)
* Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit).
18 Years
ALL
No
Sponsors
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CooperVision, Inc.
INDUSTRY
Responsible Party
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Locations
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Clinical Research Center, University of California, Berkeley
Berkeley, California, United States
Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University
Bloomington, Indiana, United States
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-18-07
Identifier Type: -
Identifier Source: org_study_id
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