Multifocal Contact Lenses for Presbyopia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial compares two types of daily disposable contact lenses to evaluate their effectiveness for individuals with presbyopia, a condition where eyes struggle to focus on close objects. Participants will wear Lens A (kalfilcon A) for one week, then switch to Lens B (stenfilcon A) for another week. The trial aims to determine which lens provides better vision and comfort. Ideal candidates regularly use multifocal contact lenses or glasses for reading and have done so for at least six months. As an unphased trial, it allows participants to directly compare two advanced lens options and contribute to enhancing vision solutions for presbyopia.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It mainly focuses on your current use of contact lenses and eye health.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
A previous study found kalfilcon A, a type of silicone hydrogel contact lens, to be generally safe with no major side effects. It improved near vision without affecting distance vision, indicating its safety and effectiveness.
Reports on stenfilcon A, another type of multifocal contact lens, show that users were very satisfied and found it safe. Most eye care professionals were pleased with its performance, indicating it is well-tolerated by many people.
Both lenses have undergone safety and comfort testing, yielding positive results. Participants found these lenses comfortable to wear and safe for daily use.12345Why are researchers excited about this trial?
Researchers are excited about the multifocal contact lenses, Lens A (kalfilcon A) and Lens B (stenfilcon A), for presbyopia because they offer a fresh approach to vision correction. Unlike traditional reading glasses or monofocal contact lenses, these multifocal lenses are designed to improve near and distance vision simultaneously, potentially eliminating the need for multiple pairs of glasses. The unique materials, kalfilcon A and stenfilcon A, offer advanced comfort and moisture retention, which may enhance the overall wearing experience and encourage more consistent use. By addressing both clarity and comfort, these lenses could significantly improve quality of life for those with presbyopia.
What evidence suggests that this trial's treatments could be effective for presbyopia?
Research has shown that multifocal contact lenses, like those tested in this trial, effectively correct presbyopia, the difficulty in seeing up close as people age. In this trial, participants will wear Lens A (kalfilcon A) and Lens B (stenfilcon A) in separate phases. Studies indicate that Lens A significantly enhances the ability to see clearly at close distances and helps people read faster compared to regular lenses. Lens B provides similar benefits, improving close-up vision while maintaining clear distance vision. Most users of these lenses achieve excellent overall vision, suggesting they effectively address presbyopia without compromising vision quality.46789
Who Is on the Research Team?
Meng C Lin
Principal Investigator
University of Berkeley
Are You a Good Fit for This Trial?
This trial is for adults aged 18 or older with presbyopia who regularly wear soft contact lenses (at least 3 days a week for the past 6 months), need at least +0.75 reading correction, have certain vision measurements, and can give informed consent.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants wear two designs of daily disposable soft multifocal contact lenses for 5-7 days each in a crossover manner
Follow-up
Participants are monitored for subjective visual acuity and other outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Lens A (kalfilcon A)
- Lens B (stenfilcon A)
Trial Overview
The study compares two types of daily disposable multifocal contact lenses—Lens A (kalfilcon A) and Lens B (stenfilcon A)—to see which performs better for people with presbyopia.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants will wear the Control Lenses in both eyes for one week and then cross over to the Test Lenses in both eyes for one week.
Participants will wear the Test Lenses in both eyes for one week and then cross over to the Control Lenses in both eyes for one week.
Find a Clinic Near You
Who Is Running the Clinical Trial?
CooperVision International Limited (CVIL)
Lead Sponsor
Dr. Patrizia Cavazzoni
CooperVision International Limited (CVIL)
Chief Medical Officer
MD from Harvard Medical School
Steven Robins
CooperVision International Limited (CVIL)
President, Americas
Bachelor of Arts from Bates College, participated in Pfizer Global Leadership Program with Harvard University
University of California, Berkeley
Collaborator
Citations
Vision Performance of a 3-Zone Progressive™ Design ...
The aim of the study was to evaluate the effectiveness of multifocal contact lens correction in patients with presbyopia and myopic refractive error. The ...
Efficacy of Presbyopia-Correcting Contact Lenses
Conclusions: There is a high-quality scientific evidence supporting the use of presbyopia-correcting CLs, with several randomized controlled ...
3.
contactlensupdate.com
contactlensupdate.com/2023/12/15/pharmacological-treatment-of-presbyopia-a-review/Pharmacological Treatment of Presbyopia: A Review
This review explored existing therapeutic drops and those in development, demonstrating their potential for significant improvements in near and intermediate ...
Presbyopia correction with multifocal contact lenses
Presbyopia correction with MF lenses leads to significantly improved near visual acuity and silent reading speed compared to SV lenses, in both monocular and ...
Presbyopia-Correcting Intraocular Lens Research
Data showed the CTF IOL resulted in less myopic shift and more patient satisfaction, and the presenter concluded that this lens may be less ...
Study Details | NCT05325931 | 1-Week Dispensing ...
Experienced soft contact lens wearing subjects will be enrolled in this 1-week, confirmatory, randomized, bilateral, 2-way crossover, double masked (subject and ...
Study Details | NCT05660577 | Evaluation of Product ...
Subject must wear their current lenses for a minimum of 12 hours per day at least four days per week; Subjects must habitually wear a multifocal lens in each ...
Vision Performance of a 3-Zone Progressive™ Design ... - PMC
As adults face middle age, most contend with presbyopia, as a progressively less flexible crystalline lens leads to near vision refractive error ...
Efficacy of a new refractive multifocal contact lens for presbyopia
No significant adverse events were observed. Refractive multifocal contact lenses improved near vision while maintaining distance vision in ...
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