Status:
COMPLETED
Comparison of Somofilcon A Daily Disposable Test Contact Lens and Somofilcon A Daily Disposable Control Contact Lens
Lead Sponsor:
CooperVision, Inc.
Conditions:
Myopia
Eligibility:
All Genders
17+ years
Phase:
NA
Brief Summary
The purpose of this study is to investigate the overall clinical performance of the somofilcon A daily disposable test soft contact lens compared to the somofilcon A daily disposable control soft cont...
Detailed Description
The purpose of this study is to evaluate the clinical performance of an investigational silicone-hydrogel contact lens (test) against a marketed silicone-hydrogel contact lens (control) when worn on a...
Eligibility Criteria
Inclusion
- Is at least 17 years of age and has full legal capacity to volunteer;
- 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
- Is presently participating in any other clinical or research study including eye related clinical or research study;
- 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).
Key Trial Info
Start Date :
November 29 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 23 2018
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT03372551
Start Date
November 29 2017
End Date
April 23 2018
Last Update
July 23 2019
Active Locations (1)
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1
Center for Contact Lens Research, University of Waterloo
Waterloo, Ontario, Canada, N2L 3G1