Comparing a Monthly Replacement Lens Versus a Daily Disposable Lens
NCT ID: NCT06046209
Last Updated: 2024-12-12
Study Results
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View full resultsBasic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2023-09-28
2023-11-22
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Control Lens, then Test Lens
Participants wore the Control Lens for 90 minutes, then the Test Lens for 90 minutes.
Control Lens
Daily disposable contact lens for 90 minutes
Test Lens
Monthly replacement contact lens for 90 minutes
Test Lens, then Control Lens
Participants wore the Test Lens for 90 minutes, then the Control Lens for 90 minutes.
Control Lens
Daily disposable contact lens for 90 minutes
Test Lens
Monthly replacement contact lens for 90 minutes
Interventions
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Control Lens
Daily disposable contact lens for 90 minutes
Test Lens
Monthly replacement contact lens for 90 minutes
Eligibility Criteria
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Inclusion Criteria
2. Had read and signed an information consent letter;
3. Were willing and able to follow instructions and maintain the appointment schedule;
4. Were habitual daily wearers of spherical single vision soft contact lenses to correct for distance vision in each eye
5. Were correctable to a visual acuity of 20/20 or better (in each eye) with sphero-cylindrical subjective refraction;
6. Had an astigmatism of ≤ 0.75DC in subjective refraction;
7. 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.
8. Demonstrated an acceptable fit with the study lenses.
Exclusion Criteria
2. Were currently habitual wearers of toric, multifocal or monovision lenses.
3. Had worn any rigid contact lenses in the past 6 months
4. Were an extended lens wearer (i.e., sleeping with their lenses)
5. Had a difference of ≥1.5 D in best vision sphere subjective refraction between eyes;
6. Had amblyopia and/or distance strabismus/binocular vision problem;
7. Had any known active ocular disease, allergies and/or infection;
8. Had a systemic condition that in the opinion of the investigator may affect a study outcome variable;
9. Were using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
10. Had a known sensitivity to the diagnostic pharmaceuticals to be used in the study;
11. Had undergone refractive error surgery or intraocular surgery;
12. Were a member of CORE directly involved in the study.
17 Years
40 Years
ALL
No
Sponsors
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Centre for Ocular Research & Education, Canada
OTHER
CooperVision, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Lyndon Jones, PhD FCOptom
Role: PRINCIPAL_INVESTIGATOR
Centre for Ocular Research and Education (CORE)
Locations
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University of Waterloo School of Optometry & Vision Science
Waterloo, Ontario, Canada
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CV-23-36
Identifier Type: -
Identifier Source: org_study_id