35 Participants NeededMy employer runs this trial

Multifocal Contact Lenses for Presbyopia

JA
Overseen ByJose A Vega, OD,MSc,PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: CooperVision International Limited (CVIL)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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?

MC

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

3. They habitually use soft contact lenses (multifocal soft contact lenses, sphere lenses for monovision, or sphere lenses for distance vision correction and spectacles for near vision correction,) and have worn lenses at least 3 days a week for at least the past six months.
4. They have a minimum reading add of +0.75DS (based on their spectacle refraction)
I am at least 18 years old.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants wear two designs of daily disposable soft multifocal contact lenses for 5-7 days each in a crossover manner

2 weeks
2 visits (in-person)

Follow-up

Participants are monitored for subjective visual acuity and other outcomes

1 week

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

Group I: Lens B then Lens AExperimental Treatment1 Intervention
Group II: Lens A then Lens BExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

CooperVision International Limited (CVIL)

Lead Sponsor

Trials
171
Recruited
14,600+
Dr. Patrizia Cavazzoni profile image

Dr. Patrizia Cavazzoni

CooperVision International Limited (CVIL)

Chief Medical Officer

MD from Harvard Medical School

Steven Robins profile image

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

Trials
193
Recruited
716,000+

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 ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37418305/

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 ...

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 ...