Multifocal Contact Lenses for Presbyopia

Overseen By Jose Vega, OD MSc, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: CooperVision International Limited (CVIL)

Disqualifiers: Ocular disorder, Systemic disorder, Aphakic, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

66 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess satisfaction with two types of soft multifocal contact lenses: Clariti® 1 Day Multifocal 3 Add and Proclear® 1 Day Multifocal. It targets individuals with presbyopia, a condition where aging affects the eyes' ability to focus on close objects. Participants will try the lenses in a random order to determine which offers better comfort and vision. Those who have used soft contact lenses for at least three months and require reading glasses may be suitable for this study. As an unphased trial, it provides a unique opportunity to explore personal comfort and vision preferences with innovative contact lenses.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

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

Research has shown that both Clariti® 1 Day Multifocal and Proclear® 1 Day Multifocal contact lenses are generally safe. The FDA has approved Clariti® lenses for daily wear, designed to offer comfort and clear vision for those experiencing age-related difficulty with near vision. Studies on similar lenses indicate a low risk, with few reports of serious side effects.

Similarly, the FDA has approved Proclear® lenses, which are known for alleviating dry eyes while providing clear vision at various distances. Users of Proclear® lenses rarely report severe side effects.

Overall, both types of lenses are well-tolerated, and existing studies suggest they are safe for daily use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these multifocal contact lenses because they offer a potentially superior solution for presbyopia, a common age-related vision problem. Unlike traditional reading glasses or single-vision contact lenses, these lenses are designed to provide clear vision at multiple distances, reducing the need to switch between different pairs of glasses. The unique feature here is the innovative design of the lenses, which allows for a seamless transition between near and far vision. Additionally, the lenses are made from omafilcon A, known for its high moisture retention, which could enhance comfort for all-day wear. This combination of advanced design and material could make these lenses a game-changer for people struggling with presbyopia.

What evidence suggests that this trial's treatments could be effective for presbyopia?

This trial will compare different multifocal contact lenses for presbyopia. Research has shown that Clariti® 1 Day Multifocal 3 Add lenses are comfortable and effective for individuals with presbyopia, a condition where focusing on close objects becomes difficult. In a study with 58 patients at four U.S. clinical sites, these lenses met or exceeded comfort needs. Made from silicone hydrogel, they allow more oxygen to reach the eyes, maintaining comfort and health. The lenses come in various designs to suit different vision needs, with options for low, medium, and high power. Proclear® 1 Day Multifocal lenses are also recognized for their comfort and effectiveness in managing presbyopia. Both types of lenses aim to provide clear vision and comfort, making them suitable choices for those with presbyopia. Participants in this trial will wear different types of study contact lenses, including these options, in a randomized order to assess their effectiveness and comfort. ^{6 7 8 9 10}

Who Is on the Research Team?

Meng C Lin, OD, Ph.D

Principal Investigator

UC Berkeley

Are You a Good Fit for This Trial?

This trial is for individuals with presbyopia (age-related difficulty focusing on close objects) and other vision issues like farsightedness or near-sightedness. Participants should be interested in trying multifocal contact lenses.

Inclusion Criteria

They have a minimum reading add of +0.75DS based on their spectacle refraction

They are able to achieve distance HCVA of +0.10 logMAR or better in each eye

My glasses prescription is between +6.00 and -10.00, with less than -0.75 astigmatism.

Exclusion Criteria

They have an ocular disorder which would normally contra-indicate contact lens wear

They have a systemic disorder which would normally contra-indicate contact lens wear

They are aphakic

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants wear two different types of study contact lenses in a randomized order for 15 minutes each

1 day

1 visit (in-person)

Follow-up

Participants are monitored for overall lens satisfaction after wearing the lenses

1 day

What Are the Treatments Tested in This Trial?

Interventions

• Clariti® 1 Day Multifocal 3 Add
• Proclear® 1 Day Multifocal

Trial Overview The study compares overall satisfaction between two types of soft multifocal contact lenses: Proclear® 1 Day Multifocal and Clariti® 1 Day Multifocal, each available in low, medium, and high ADD power for better close-up vision.

How Is the Trial Designed?

Group I: omafilcon A lenses first, then medium ADD power somofilcon A lens Experimental Treatment 2 Interventions

Participants will wear two different types of study contact lenses, in a randomized order of testing for the two study contact lens types.

Group II: omafilcon A lenses first, then low ADD power somofilcon A lens Experimental Treatment 2 Interventions

Participants will wear two different types of study contact lenses, in a randomized order of testing for the two study contact lens types.

Group III: omafilcon A lenses first, then high ADD power somofilcon A lens Experimental Treatment 2 Interventions

Participants will wear two different types of study contact lenses, in a randomized order of testing for the two study contact lens types.

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

University of California, Berkeley

Collaborator

Trials

193

Recruited

716,000+

Citations

1. ctv.veeva.com ctv.veeva.com/study/a-clinical-comparison-of-proclear-r-1-day-multifocal-and-clariti-r-1-day-multifocal-3-add

A Clinical Comparison of Proclear® 1 Day Multifocal and ... The aim of this study is to compare the overall lens satisfaction between two soft multifocal contact lenses.

2. coopervision.com coopervision.com/practitioner/ecp-viewpoints/from-the-lane/clariti-1-day-multifocal-3-add-your-patients-presbyopia

The clariti® 1 day multifocal 3 Add for Your Patients with ... In a recent study that enrolled 58 patients at four U.S. clinical sites, the new clariti 1 day multifocal 3 Add met or exceeded the comfort needs of wearers ...

3. coopervision-mena.com coopervision-mena.com/practitioner/our-products/clariti-1-day-family/clariti-1-day-multifocal

clariti® 1 day multifocal - Cooper Vision With clariti® 1 day multifocal contact lenses, you can offer your presbyopic patients the benefits of 1 day silicone hydrogel (SiHy), while saving them from ...

4. coopervision.com coopervision.com/practitioner/ecp-viewpoints/from-the-lane/dual-opportunity-unlock-practice-potential-myday-and-clariti-1-day

Unlock Practice Potential with MyDay® and clariti® 1 day In this ECP Viewpoints article, Dr. Jordan Dau explains how he successfully offers both clariti 1 day and MyDay silicone hydrogel 1 day lens ...

5. reviewofoptometry.com reviewofoptometry.com/news/article/new-daily-multifocal-lens-accommodates-more-presbyopes

New Daily Multifocal Lens Accommodates More Presbyopes The “Clariti 1-day Multifocal 3 Add” uses different optical designs for low, medium and high plus powers and offers a wider sphere range than its predecessor.

6. coopervision.com coopervision.com/practitioner/our-products/clariti-1-day-family/clariti-1-day-multifocal

clariti® 1 day multifocal 3 Add Full clariti 1 day multifocal product information including features, specifications, order and trial information, and package insert for practitioners.

7. eyeglassworld.com eyeglassworld.com/clariti-1-day-multifocal-3-add-high-add-90-pack/p/353740?srsltid=AfmBOor0Jg64AVdlwawQBORddmzg4Ownh-6X8aSJWIhUFGLhYzbkn4F2

Clariti 1 Day Multifocal 3 Add High Add 90 Pack An innovative 3 Add design that caters to all levels of presbyopia to provide optimal visual acuity at all distances.

8. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf18/K181920.pdf

Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily ... The CLARITI 1 DAY MULTIFOCAL TORIC (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with. UV blocker is indicated for daily wear ...

9. americasbest.com americasbest.com/clariti-1-day-multifocal-3-add-medium-add-30-pack/p/354052?srsltid=AfmBOorEiUzxtJho4zsWyypwMk91EibEF9_LIOFtt-oLcomHC5zAbCm8

Clariti 1 Day Multifocal 3 Add Medium Add 30 Pack An innovative 3 Add design that caters to all levels of presbyopia to provide optimal visual acuity at all distances.

10. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/08/NCT05457608/Prot_SAP_000.pdf

Final Clinical Evaluation of clariti Monthly Multifocal and ... This study is considered to be a non-significant risk study based on United State Food and Drug administration (FDA) and International Standards ...