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

Trial Summary

What is the purpose of this trial?

The aim of this study is to compare the overall lens satisfaction between two soft multifocal contact lenses.

Research Team

Meng C Lin, OD, Ph.D

Principal Investigator

UC Berkeley

Eligibility Criteria

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

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

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

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

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

Treatment Details

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.

Participant Groups

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+