Status:
COMPLETED
Comparing Biofinity Toric Multifocal to Ultra Multifocal for Astigmatism
Lead Sponsor:
CooperVision, Inc.
Conditions:
Astigmatism
Presbyopia
Eligibility:
All Genders
17+ years
Phase:
NA
Brief Summary
The objective of the study was to compare the handling and performance of Biofinity Toric Multifocal to Ultra Multifocal for Astigmatism.
Detailed Description
The objective of the study was to compare the handling and performance of Biofinity Toric Multifocal to Ultra Multifocal for Astigmatism. This is a prospective, randomized, participant masked, crossov...
Eligibility Criteria
Inclusion
- Is at least 42 years of age and has full legal capacity to volunteer;
- Has read and signed an information consent letter;
- Self reports having a full eye examination in the previous two years;
- Anticipates being able to wear the study lenses for at least 8 hours a day, 5 days a week;
- Is willing and able to follow instructions and maintain the appointment schedule;
- Habitually wears soft contact lens for the past 3 months minimum;
- Has refractive astigmatism of at least -0.75DC;
- Is presbyopic and requires a reading addition of at least +0.75D;
- Can be fit and achieve binocular distance vision of at least 20/30 Snellen (or +0.20 logMAR) which participants also deem to be 'acceptable', with the available study lens parameters (sphere +4 to -6; cylinder -0.75 to -1.75DC; near addition +0.75 to +2.50).
Exclusion
- Is participating in any concurrent clinical or research study;
- Habitually wears one of the study contact lenses;
- 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 contact lens wear or a study outcome variable;
- Has known sensitivity to the diagnostic sodium fluorescein and/or the care product Opti-Free PureMoist being used in the study;
- Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;
- Has undergone refractive error surgery. \* For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
Key Trial Info
Start Date :
August 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 29 2021
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT04404725
Start Date
August 6 2020
End Date
July 29 2021
Last Update
March 3 2022
Active Locations (7)
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1
Athens Eye care
Athens, Ohio, United States, 45701
2
Nittany Eye Associates
State College, Pennsylvania, United States, 16801
3
Glasses Half Full
Edmonton, Alberta, Canada, T5N1S5
4
Oakley Eyecare
Winnipeg, Manitoba, Canada, R2C 3B4