Status:
COMPLETED
Comparing the Performance of 1 Day Multifocal Contact Lenses
Lead Sponsor:
CooperVision, Inc.
Conditions:
Presbyopia
Eligibility:
All Genders
42+ years
Phase:
NA
Brief Summary
The objective of the study was to compare the lens handling and performance of Lens A to habitually worn multifocal contact lenses and to the competitor Lens B.
Detailed Description
The objective of the study was to compare the lens handling and performance of Lens A to habitually worn multifocal contact lenses and to the competitor Lens B. This was a prospective, randomized, par...
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 multifocal soft contact lenses, for the past 3 months minimum;
- Has refractive astigmatism no higher than -0.75DC;
- Is presbyopic and requires a reading addition of at least +0.75D and no more than +2.50D;
- 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; near addition or LOW, MEDIUM, HIGH).
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 that contraindicates contact lens wear;
- 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 used in the study;
- Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;
- Has undergone refractive error surgery or intraocular surgery.
Key Trial Info
Start Date :
July 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04449263
Start Date
July 27 2020
End Date
December 30 2020
Last Update
June 22 2021
Active Locations (5)
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1
Scripps Poway Eyecare
San Diego, California, United States, 92131
2
Golden Optometric Group
Whittier, California, United States, 90606
3
Golden Vision
Sarasota, Florida, United States, 34237
4
Kannarr Eye Care
Pittsburg, Kansas, United States, 66762