Astigmatism Clinical Trial
Official title:
Performance Evaluation of Two Silicone Hydrogel Toric Lens Designs in Habitual Soft Contact Lens Wearers
Verified date | May 2023 |
Source | Coopervision, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objective of the study is to compare the clinical performance of two monthly toric silicone hydrogel contact lenses in habitual wearers, when worn for 1-month each.
Status | Completed |
Enrollment | 60 |
Est. completion date | December 30, 2023 |
Est. primary completion date | December 30, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 39 Years |
Eligibility | Inclusion Criteria: 1. Is between 18 and 39 years of age (inclusive) and has full legal capacity to volunteer; 2. Has read and signed an information consent letter; 3. Self-reports having a full eye examination in the previous two years; 4. Anticipates being able to wear the study lenses for at least 8 hours a day, 6 days a week; 5. Is willing and able to follow instructions and maintain the appointment schedule; 6. Habitually wears of toric soft contact lenses binocularly. 1. No more than 1/3 of the participants should be wearing daily disposable soft toric lenses; 2. the remaining 2/3+ of the participants must be planned frequent replacement soft toric lens wearers as follows: - i. TOTAL30 for Astigmatism: maximum of 3 (~10%) (no target percentage - ii. Biofinity toric: maximum of 13 (~40%) (PLUS a target of minimum 10 (~30%)) - iii. Air Optix for Astigmatism (inclusive of +Hydraglyde): maximum of 10 (~30%) (PLUS a target of minimum 7 (~20%)) - iv. ULTRA for Astigmatism: maximum of 5 (~15%) (no target percentage) - v. Acuvue Vita for Astigmatism: maximum of 3 (~10%) (no target percentage) - vi. Acuvue Oasys for Astigmatism: maximum of 10 (~30%) (no target percentage) - vii. Other brands of frequent replacement: maximum of 7 (~20%) (no target percentage) 7. Has refractive astigmatism of at least -0.75DC but no more than -2.75DC in each eye that is correctable with a soft toric lens with a cylinder power of no greater than -2.25DC; 8. Is ammetropic and requires a spectacle spherical component of +8.00 to -10.00D inclusively; 9. Can be fit and achieve binocular distance vision of at least 20/32 Snellen with the available lens parameters Exclusion Criteria: 1. Is participating in any concurrent clinical or research study; 2. Has any known active ocular disease and/or infection that contraindicates contact lens wear; 3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable; 4. Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable; 5. Has known sensitivity to the diagnostic sodium fluorescein used in the study; 6. Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment; 7. Has undergone refractive error surgery or intraocular surgery. |
Country | Name | City | State |
---|---|---|---|
Canada | Eyes on Sheppard Clinic | Toronto | Ontario |
Canada | Spadina Optometry | Toronto | Ontario |
United States | ProCare Vision Center | Granville | Ohio |
United States | Kannarr Eye Care | Pittsburg | Kansas |
United States | Sacco Eye Group | Vestal | New York |
Lead Sponsor | Collaborator |
---|---|
Coopervision, Inc. | CORE |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Lens Handling on Removal | Lens Handling on Removal, using a 0-100 scale (0= Worst, 100=Best) | One month of wear | |
Secondary | Distance Visual Acuity | Distance Visual Acuity, using Snellen converted to logMAR | One month wear |
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