Status:
COMPLETED
Multicenter Dispensing Study of Biofinity Toric Made-To-Order Lenses in Extended Power Ranges
Lead Sponsor:
CooperVision, Inc.
Conditions:
Myopia
Astigmatism
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The study hypothesis is that the Biofinity Toric XR lenses will perform as well as or better than the participants' habitual contact lenses.
Detailed Description
The study hypothesis is that the Biofinity Toric XR lenses will perform as well as or better than the participants' habitual contact lenses. Further, that a minimum of 80% of those enrolled will compl...
Eligibility Criteria
Inclusion
- Has had an oculo-visual examination in the last two years
- Is at least 18 years of age and has full legal capacity to volunteer
- Has read and understood the information consent letter
- Is willing and able to follow instructions and maintain the appointment schedule
- Is correctable to a visual acuity of 20/50 or better (in at least one eye)
- Currently wears soft toric contact lenses in both eyes
- Subject contact lens prescription must fall under one of the contact lens power ranges for at least one eye:
- -20.00D to -10.50D spherical powers and cylinder powers from - 0.75 to -2.25
- +8.50D to +20.00D spherical powers and cylinder powers from - 0.75 to -2.25
- -20.00D to -6.50D spherical powers and cylinder powers from -2.75 to -5.75
- -6.00D to +6.00D spherical powers and cylinder powers from -2.75 to -5.75
- +6.50D to +20.00D spherical powers and cylinder powers from-2.75 to -5.75
- Has clear corneas and no active ocular disease
- Demonstrates an acceptable fit with the study lenses
Exclusion
- Has never worn contact lenses before;
- Has any systemic disease affecting ocular health;
- Is using any systemic or topical medications that will affect ocular health;
- Has any ocular pathology or abnormality that would affect the wearing of contact lenses;
- Has undergone corneal refractive surgery;
- Is participating in any other type of eye related clinical or research study.
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT02193178
Start Date
July 1 2014
End Date
April 1 2016
Last Update
July 29 2020
Active Locations (2)
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1
Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University
Bloomington, Indiana, United States, 47405
2
Texas Eye Research and Technology Center (TERTC) College of Optometry, University of Houston
Houston, Texas, United States, 77204