Status:
COMPLETED
Comparing The Performance Of Two Different Daily Disposable Lenses (MIKI)
Lead Sponsor:
CooperVision, Inc.
Conditions:
Myopia
Eligibility:
All Genders
17+ years
Phase:
NA
Brief Summary
The objective of the study is to evaluate and compare the performance of study test lens to study control lens, when worn on a daily disposable modality over a period of approximately one week each
Detailed Description
The study is a prospective, double masked (investigator and participant), bilateral, randomized,one week cross-over dispensing study, which evaluates the study test lens and control lens.
Eligibility Criteria
Inclusion
- Is at least 17 years of age and has full legal capacity to volunteer;
- Has read and signed an information consent letter;
- Is willing and able to follow instructions and maintain the appointment schedule;
- Habitually wears soft contact lenses in daily wear, for minimum of 6-months;
- Is correctable to a visual acuity of 20/40 or better (in each eye) with the study lenses;
- Has an astigmatism of ≤ 1.00 D in subjective refraction;
- Can be fit with study contact lenses with a power between -2.00 and -5.00 DS;
- Demonstrates an acceptable fit with the study lenses;
- Habitually wears single vision soft contact lenses for at least 8 hours per day, 5 days a week, and is willing to wear contact lenses for at least 12 hours a day in the study.
Exclusion
- Is participating in any concurrent clinical or research study;
- Has any known active\* ocular disease and/or infection;
- 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 a study outcome variable;
- Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
- Is pregnant, lactating or planning a pregnancy at the time of enrolment because the associated hormonal changes cause changes in the tear layer which impact contact lens comfort. Verbal confirmation at the screening visit is sufficient;
- Is aphakic;
- Has undergone refractive error surgery;
- Is an employee of the Centre for Ocular Research \& Education;
- Has participated in the BOXER (i.e. EX-MKTG-107, phases 1 or 2) or BASSET (EXMKTG-113) Study;
- Has participated in any clinical trials within a week prior to the study.
Key Trial Info
Start Date :
September 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2021
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT04492397
Start Date
September 30 2020
End Date
March 31 2021
Last Update
June 23 2021
Active Locations (1)
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1
University of Waterloo
Waterloo, Ontario, Canada, N2L 3G1