Contact Lenses for Presbyopia

Not yet recruiting at 1 trial location

Overseen By Kelly Voltz

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: CooperVision International Limited (CVIL)

Must not be taking: Systemic medications

Disqualifiers: Ocular disorders, Systemic disorders, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of a new contact lens, Lens A (stenfilcon A), for individuals with presbyopia, a common condition that impairs close-up vision. Participants will wear this experimental lens to assess its impact on near vision. The trial seeks individuals aged 40 or older who already use MyDay contact lenses and struggle with near vision tasks. Those experiencing presbyopia symptoms and meeting these criteria may be suitable for the study. As an unphased trial, it offers a unique opportunity to contribute to the early understanding of how Lens A can enhance near vision for presbyopia patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are using any medications that might affect contact lens wear, the investigator may decide it's necessary.

What prior data suggests that these contact lenses are safe for presbyopia?

Research has shown that the stenfilcon A contact lens, also known as Lens A, is generally safe and comfortable. In one study, 95% of eye care professionals found the lens easy to fit, indicating that users find it comfortable and easy to handle. Another study reported high satisfaction rates, with 92% of eye care professionals recommending the lens and 94% noting it was quick to fit.

These findings suggest that most users do not experience major issues with this lens. No reports of serious side effects have been linked to stenfilcon A, providing reassurance for those considering joining a trial. Overall, these lenses appear to be a safe choice for individuals dealing with presbyopia, the difficulty of focusing on close objects with age. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional reading glasses or multifocal contact lenses that most people with presbyopia use, Lens A made from stenfilcon A offers a new approach. Researchers are excited because this material is designed to provide better comfort and visual clarity. Unlike other lenses, stenfilcon A has a unique ability to retain moisture, which could reduce dryness and irritation, common complaints among contact lens users. This makes it a promising option for those seeking a more comfortable and effective solution to presbyopia.

What evidence suggests that Lens A is effective for presbyopia?

Research has shown that multifocal contact lenses, such as those made from stenfilcon A, significantly enhance close-up vision and reading speed compared to regular lenses. One study found that fewer than 20% of users noticed any changes in vision quality over time, indicating stable results. Over 96% of users were successfully fitted with these lenses after trying just a few pairs, suggesting ease of use and effectiveness. Additionally, most eye care professionals and patients report high satisfaction with these lenses, indicating they work well for presbyopia, which is difficulty seeing things up close. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for people aged 40 or older who already wear certain daily contact lenses and have trouble seeing up close due to presbyopia. Participants must meet specific vision requirements and be able to give informed consent.

Inclusion Criteria

Habitually wear MyDay sphere or MyDay Energys contact lenses (including sphere lenses for monovision, or sphere lenses for distance vision correction and spectacles for near vision correction)

Minimum reading add of +0.75DS and no more than +2.50DS based on manifest refraction

Able to achieve distance HCHL visual acuity of +0.10 logMAR or better in each eye with manifest refraction

Exclusion Criteria

Have a systemic disorder which would normally contraindicate contact lens wear

Self-report as pregnant, lactating or planning a pregnancy at the time of enrollment

Participating in any concurrent clinical or research trial

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants use an at-home trial kit with contact lenses for daily wear

1 day

At-home trial

Follow-up

Participants are monitored for readiness to finalize a multifocal contact lens prescription

1 day

What Are the Treatments Tested in This Trial?

Interventions

• Lens A (stenfilcon A)

Trial Overview

The study is testing the experience of fitting a new type of contact lens (Lens A, stenfilcon A) in people with presbyopia who currently use similar lenses. It focuses on how well these lenses work and feel during trial fitting.

How Is the Trial Designed?

Group I: Lens A ( stenfilcon A) Experimental Treatment 1 Intervention

All participants will wear lens A

Who Is Running the Clinical Trial?

CooperVision International Limited (CVIL)

Lead Sponsor

Trials

171

Recruited

14,600+

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

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12882888/

Comparing Clinical Outcomes of Various Presbyopia ... - PMC

Fewer than 20% of cases experienced a change in composite description of acuities > 0.1 logMAR between 6 and 12 months postop. Trial ...

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1367048423000577

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 ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07600645

Study Details | NCT07600645 | Contact Lens Trial Fitting ...

Members are chosen based on the scientific skills and knowledge needed to monitor the particular trial. Also called a data safety and monitoring board, or DSMB.

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12604522/

Prospective Evaluation of a Novel Multifocal Toric Daily ...

Over 96% of subjects were fit in the optimized lens power with 2 pairs of lenses or less. After 2-weeks of lens wear, the mean binocular high ...

5.

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 ...

6.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf22/P220007B.pdf

Summary of Safety and Effectiveness Data (SSED)

The applicant performed a clinical study to establish a reasonable assurance of safety and effectiveness of the Alcon Precision7TM (serafilcon A) ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05763628

Performance Evaluation of Different Daily Disposable ...

Also called a data safety and monitoring board, or DSMB. ... Participants wore Control Lens for 2 weeks, then crossed over to Test Lens for 2 weeks. Intervention/ ...