Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
25 participants
INTERVENTIONAL
2015-04-30
2015-07-31
Brief Summary
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The investigational test lens was not the final optical design and the study was not used for design validation.
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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Phenacite
Subjects will be randomized to wear the Phenacite contact lenses binocularly.
Phenacite
Subjects will be randomized to wear the Phenacite contact lenses binocularly.
comfilcon A
Subjects will be randomized to wear the comfilcon A contact lenses binocularly.
comfilcon A
Subjects will be randomized to wear the comfilcon A contact lenses binocularly.
Phenacite
Subjects will be randomized to wear the Phenacite contact lenses binocularly.
comfilcon A
Subjects will be randomized to wear the comfilcon A contact lenses binocularly.
Interventions
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Phenacite
Subjects will be randomized to wear the Phenacite contact lenses binocularly.
comfilcon A
Subjects will be randomized to wear the comfilcon A contact lenses binocularly.
Eligibility Criteria
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Inclusion Criteria
* Between 18 and 35 years of age and has full legal capacity to volunteer
* Has read and understood the informed consent letter
* Is willing and able to follow instructions and maintain the appointment schedule
* Is correctable to a visual acuity of 20/25 or better (in each eye) with their habitual correction or 20/20 best corrected
* Currently wears, or has previously successfully worn, soft contact lenses between -1.00D and -4.00D
* Spherical Contact Lens Rx between -1.00 and -4.00 and spectacle cylinder ≤-0.75
* Has not worn lenses for at least 12 hours before the initial visit
* Has a subjective response at baseline, which indicates suitability for this study
* Currently spends a minimum of 4 hours a day; 5 days a week on digital devices and can replicate this time during the study period
* Is willing and able to wear the study contact lenses a minimum of 10 hours per day; 5 days a week.
Exclusion Criteria
* Any systemic disease affecting ocular health
* Is using any systemic or topical medications that will affect ocular health
* Has known sensitivity to the diagnostic pharmaceuticals or study products used in this study.
* Has any ocular pathology or anomaly that would affect the wearing of the lenses
* Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye
* Is aphakic
* Has anisometropia of \>1.00
* Has undergone corneal refractive surgery
* Has strabismus
* Has any ocular amblyopia \>= 1line of HC Visual Acuity
* Is participating in any other type of eye related clinical or research study
* Has participated in study CV-14-32.
18 Years
35 Years
ALL
No
Sponsors
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CooperVision, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Pete Kollbaun, OD PhD
Role: PRINCIPAL_INVESTIGATOR
CORL Indiana University
Locations
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Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University
Bloomington, Indiana, United States
Countries
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Other Identifiers
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CV-15-16
Identifier Type: -
Identifier Source: org_study_id