Status:
COMPLETED
Performance Evaluation of Two Daily Disposable Toric Lens Designs in Habitual Soft Contact Lens Wearers
Lead Sponsor:
CooperVision, Inc.
Conditions:
Astigmatism
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective of the study is to compare the clinical performance of two different daily disposable, SiHy toric contact lens types, Lens A and Lens B, in existing soft lens wearers when worn for one w...
Detailed Description
This study is a prospective, bilateral eye, double-masked, randomized, 1-week cross-over, daily-wear design involving two different daily disposable toric lens types. Each lens type will be worn for a...
Eligibility Criteria
Inclusion
- Is at least 18 years of age and has full legal capacity to volunteer;
- Has read and signed an information consent letter;
- Self reports having a full eye examination in the previous two years;
- Anticipates being able to wear the study lenses for at least 12 hours a day, 7 days a week;
- Is willing and able to follow instructions and maintain the appointment schedule;
- Habitually wears toric soft contact lenses binocularly, of any replacement frequency, for the past 3 months minimum;
- Has refractive astigmatism at least -0.75DC in each eye, maximum -2.25DC;
- Has refractive cylinder axis either between 155 to 25 or between 65 and 115 degrees;
- Is myopic and requires a spectacle spherical component of -1.00D to -6.50D inclusively;
- Can be fit and achieve binocular distance vision of at least 20/30 Snellen with the available lens parameters
Exclusion
- Is participating in any concurrent clinical or research study;
- Habitually wears one of the study contact lenses;
- Has any known active ocular disease and/or infection that contraindicates contact lens wear;
- Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
- Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable;
- Has known sensitivity to the diagnostic sodium fluorescein used in the study;
- Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;
- Has undergone refractive error surgery or intraocular surgery.
Key Trial Info
Start Date :
March 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 2 2021
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04831515
Start Date
March 29 2021
End Date
July 2 2021
Last Update
February 15 2022
Active Locations (4)
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1
Golden Optometric Group
Whittier, California, United States, 90606
2
Golden Vision
Sarasota, Florida, United States, 34237
3
Sacco Eye Group
Vestal, New York, United States, 13850
4
Athens Eye Care
Athens, Ohio, United States, 45701