Clinical Evaluation of Two Multifocal Contact Lenses
Not Applicable
Completed
- Conditions
- Presbyopia
- Registration Number
- NCT05457608
- Lead Sponsor
- Coopervision, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Subjective Comfort Ratings on Insertion 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 Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the key differences in visual performance between Clariti Monthly and Clariti 1 Day multifocal contact lenses in presbyopia patients?
How do the optical designs of Clariti multifocal lenses compare to other commercially available multifocal contact lenses in terms of patient comfort and visual acuity?
What are the potential adverse events associated with Clariti multifocal lenses and how do they compare to standard multifocal lenses in presbyopia management?
Are there specific biomarkers or ocular characteristics that predict better adaptation to monthly versus daily disposable multifocal contact lenses in presbyopia patients?
How does the clinical evaluation of Clariti multifocal lenses in NCT05457608 contribute to the understanding of multifocal lens efficacy in presbyopia treatment?
Trial Locations
- Locations (1)
School of Optometry Clinic, National Autonomous University (UNAM)
🇲🇽Mexico City, Mexico
School of Optometry Clinic, National Autonomous University (UNAM)🇲🇽Mexico City, Mexico