Status:
COMPLETED
To Evaluate The Performance Of Two Monthly Replacement Silicone Hydrogel Contact Lenses After 1-month Of Wear
Lead Sponsor:
CooperVision, Inc.
Conditions:
Myopia
Eligibility:
All Genders
17+ years
Phase:
NA
Brief Summary
To evaluate the performance of two monthly replacement silicone hydrogel contact lenses in habitual FRP CL wearers when worn for 1-month.
Detailed Description
This study will be a prospective, randomized, double-masked, single-site, 1-month cross-over design involving bilateral eye daily wear of two different monthly replacement CL types. Each lens will be ...
Eligibility Criteria
Inclusion
- Is at least 17 years of age and has full legal capacity to volunteer;
- Self-reports having had a full eye examination within the previous 2 years;
- Has read and signed an information consent letter;
- Is willing and able to follow instructions and maintain the appointment schedule;
- Is a habitual wearer of frequent replacement contact lenses;
- Anticipates no difficulty wearing the contact lenses for 6 days/week and 8 hours/day during the study;
- Has refractive astigmatism no higher than -0.75DC in each eye;
- Can be successfully fit with both study lens types;
- Achieves at least 0.4 logMAR VA monocularly and at least 0.2 logMAR VA binocularly with each study lens type.
Exclusion
- Is participating in any concurrent clinical research study;
- Has any known active ocular disease and/or infection;
- Has an unstable systemic condition that in the opinion of the investigator may affect vision or contact lens comfort across the 2-month study duration;
- Is using any systemic or topical medications in an irregular routine that in the opinion of the investigator may affect vision or contact lens comfort across the 2-month study duration;
- Has known sensitivity to the diagnostic sodium fluorescein to be used in the study;
- Is an employee of the Centre for Ocular Research \& Education.
Key Trial Info
Start Date :
April 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 13 2022
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT05333965
Start Date
April 27 2022
End Date
September 13 2022
Last Update
October 23 2023
Active Locations (1)
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1
School of Optometry & Vision Science
Waterloo, Canada, N2L 3G1