Status:
COMPLETED
Comparing a Monthly Replacement Lens Versus a Daily Disposable Lens
Lead Sponsor:
CooperVision, Inc.
Collaborating Sponsors:
Centre for Ocular Research & Education, Canada
Conditions:
Myopia
Eligibility:
All Genders
17-40 years
Phase:
NA
Brief Summary
The purpose of this study was to compare subjective ratings of lens handling at insertion for a monthly replacement lens versus a daily disposable lens in habitual soft lens wearers.
Detailed Description
This was a non-dispensing, randomized, double-masked, crossover study. Participants wore 2 different contact lenses bilaterally over 4 study visits, all conducted on the same day. Estimated duration o...
Eligibility Criteria
Inclusion
- Were 17 to 40 years of age and have full legal capacity to volunteer;
- Had read and signed an information consent letter;
- Were willing and able to follow instructions and maintain the appointment schedule;
- Were habitual daily wearers of spherical single vision soft contact lenses to correct for distance vision in each eye
- Were correctable to a visual acuity of 20/20 or better (in each eye) with sphero-cylindrical subjective refraction;
- Had an astigmatism of ≤ 0.75DC in subjective refraction;
- Could be fit with the study contact lenses with a power between -1.00 and -6.00DS; this translates to best corrected vision sphere refraction that vertexes to a CL power between -1.00 and -6.00 (inclusive) at screening visit.
- Demonstrated an acceptable fit with the study lenses.
Exclusion
- Had taken part in another clinical research study within the last 14 days;
- Were currently habitual wearers of toric, multifocal or monovision lenses.
- Had worn any rigid contact lenses in the past 6 months
- Were an extended lens wearer (i.e., sleeping with their lenses)
- Had a difference of ≥1.5 D in best vision sphere subjective refraction between eyes;
- Had amblyopia and/or distance strabismus/binocular vision problem;
- Had any known active ocular disease, allergies and/or infection;
- Had a systemic condition that in the opinion of the investigator may affect a study outcome variable;
- Were using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
- Had a known sensitivity to the diagnostic pharmaceuticals to be used in the study;
- Had undergone refractive error surgery or intraocular surgery;
- Were a member of CORE directly involved in the study.
Key Trial Info
Start Date :
September 28 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 22 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06046209
Start Date
September 28 2023
End Date
November 22 2023
Last Update
December 12 2024
Active Locations (1)
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1
University of Waterloo School of Optometry & Vision Science
Waterloo, Ontario, Canada, N2L 3G1