A Dispensing Clinical Trial of Comfilcon A Extended Range Multifocal Lenses
NCT ID: NCT02719353
Last Updated: 2020-07-30
Study Results
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View full resultsBasic Information
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COMPLETED
NA
14 participants
INTERVENTIONAL
2016-03-31
2016-08-31
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
SINGLE
Study Groups
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comfilcon A Extended Range test lens
Subjects will be randomized to wear either the test or control pair of lens, then cross over to the alternate pair.
comfilcon A Extended Range test lens
contact lens
comfilcon A control lens
contact lens
comfilcon A control lens
Subjects will be randomized to wear either the test or control pair of lens, then cross over to the alternate pair.
comfilcon A Extended Range test lens
contact lens
comfilcon A control lens
contact lens
Interventions
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comfilcon A Extended Range test lens
contact lens
comfilcon A control lens
contact lens
Eligibility Criteria
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Inclusion Criteria
* Has had a self-reported oculo-visual examination in the last two years
* Is 50 years of age or greater and has full legal capacity to volunteer
* Is able to read and understand the informed consent
* Is willing and able to follow instructions and maintain the appointment schedule
* Has a spherical distance contact lens prescription between -1.00 and -5.00D (Diopters) (inclusive)
* Near Add Power requirement of +2.25D or greater
* Has spectacle cylinder 0.75 D in both eyes
* Has normal binocularity (no amblyopia, no strabismus, no habitually uncorrected anisometropia ≥ 2.00D)
* Has monocular best-corrected distance visual acuity of 20/30 or better in each eye
* Has clear corneas and no active ocular disease
* Has not worn gas permeable contact lenses for 1 month prior to the study
Exclusion Criteria
* Has never worn contact lenses before
* Has any systemic disease affecting ocular health
* Is using any systemic or topical medications that will affect ocular health
* Has any ocular pathology or abnormality that would affect the wearing of contact lenses
* Is aphakic (i.e. missing their natural lens inside their eye)
* Has uncorrected anisometropia (i.e. difference in the prescription between the eyes) of ≥2.00 D
* Has undergone corneal refractive surgery
* Is participating in any other type of eye related clinical or research study.
50 Years
ALL
Yes
Sponsors
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CooperVision, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Pete S Kollbaum, O.D.
Role: PRINCIPAL_INVESTIGATOR
Indiana University
Locations
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CORL, Indiana University
Bloomington, Indiana, United States
Countries
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Other Identifiers
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CV-16-02
Identifier Type: -
Identifier Source: org_study_id
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