NCT05457608CompletedNot Applicable
Clinical Evaluation of Clariti Monthly Multifocal and Clariti 1 Day Multifocal
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Coopervision, Inc.
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Subjective Comfort Ratings on Insertion
Study Overview
Brief Summary
The aim of this study is to evaluate the patient subjective experiences of the monthly multifocal lens when compared to the daily disposable multifocal lens after 15 minutes of daily wear.
Detailed Description
This is a single-blind, interventional, prospective, direct refit, bilateral wear study.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 42 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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, or sphere lenses for monovision, or sphere lenses for monovision, or sphere lenses for distance vision correction and use spectacles for near vision correction, 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 (powers +4.00 to -6.00DS).
Exclusion Criteria
- •Is participating in any concurrent clinical or research study.
- •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.
Arms & Interventions
Lens A
Experimental
All participants wore lens A for 15 minutes (Period 1)
Intervention: Lens A (Device)
Lens B
Experimental
All participants wore lens B for 15 minutes (Period 2)
Intervention: Lens B (Device)
Outcomes
Primary Outcomes
Subjective Comfort Ratings on Insertion
Time Frame: At insertion
Subjective comfort ratings on insertion were measured on a scale from 0 - 10, where 0= extremely uncomfortable and 10= can't feel.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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