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
44 participants
INTERVENTIONAL
2015-11-30
2016-03-31
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
DOUBLE
Study Groups
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Phenacite Test lens then comfilcon A control lens
Participants were randomized to wear Phenacite test lens for one week then cross-over to wear comfilcon A control lens for one week.
Phenacite
contact lens
comfilcon A
contact lens
Comfilcon A control lens then Phenacite test Lens
Participants were randomized to wear comfilcon A control lens for one week then cross over to Phenacite test lens for one week.
Phenacite
contact lens
comfilcon A
contact lens
Interventions
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Phenacite
contact lens
comfilcon A
contact lens
Eligibility Criteria
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Inclusion Criteria
* Oculo-visual examination in the last two years
* 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 (Diopoter) 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
* Has never worn contact lenses before
* 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 (High Contrast) Visual Acuity
* Is participating in any other type of eye related clinical or research study
* Has previously participated in study of the Phenacite lenses
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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Lyndon Jones
Role: PRINCIPAL_INVESTIGATOR
CCLR, University of Waterloo
Pete Kollbaum, OD, PhD
Role: PRINCIPAL_INVESTIGATOR
CORL, Indiana University
Meng Lin, OD, PhD
Role: PRINCIPAL_INVESTIGATOR
CRC, University of California, Berkeley
Locations
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University of California
Berkeley, California, United States
CORL, Indiana University
Bloomington, Indiana, United States
Center for Contact Lens Research, University of Waterloo
Waterloo, Ontario, Canada
Countries
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Other Identifiers
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CV-15-41
Identifier Type: -
Identifier Source: org_study_id
NCT02642341
Identifier Type: -
Identifier Source: nct_alias
NCT02642354
Identifier Type: -
Identifier Source: nct_alias