A Clinical Comparison of Proclear® 1 Day Multifocal and Clariti® 1 Day Multifocal 3 Add

NCT ID: NCT06869044

Last Updated: 2025-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-11

Study Completion Date

2025-04-30

Brief Summary

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

Detailed Description

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The aim of the study is to evaluate the overall lens satisfaction between two soft multifocal contact lenses when compared to each other after 15 minutes of daily wear each.

Conditions

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Myopia Hyperopia Presbyopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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omafilcon A lenses first, then low ADD power somofilcon A lens

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

Group Type EXPERIMENTAL

omafilcon A lens

Intervention Type DEVICE

Participants will be randomized to wear omafilcon A lens for 15 minutes.

Low ADD power somofilcon A lens

Intervention Type DEVICE

Participants will be randomized to wear low ADD power somofilcon A lens for 15 minutes.

omafilcon A lenses first, then medium ADD power somofilcon A lens

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

Group Type EXPERIMENTAL

omafilcon A lens

Intervention Type DEVICE

Participants will be randomized to wear omafilcon A lens for 15 minutes.

Medium ADD power somofilcon A lens

Intervention Type DEVICE

Participants will be randomized to wear medium ADD power somofilcon A lens for 15 minutes.

omafilcon A lenses first, then high ADD power somofilcon A lens

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

Group Type EXPERIMENTAL

omafilcon A lens

Intervention Type DEVICE

Participants will be randomized to wear omafilcon A lens for 15 minutes.

High ADD power somofilcon A lens

Intervention Type DEVICE

Participants will be randomized to wear high ADD power somofilcon A lens for 15 minutes.

Interventions

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omafilcon A lens

Participants will be randomized to wear omafilcon A lens for 15 minutes.

Intervention Type DEVICE

Low ADD power somofilcon A lens

Participants will be randomized to wear low ADD power somofilcon A lens for 15 minutes.

Intervention Type DEVICE

Medium ADD power somofilcon A lens

Participants will be randomized to wear medium ADD power somofilcon A lens for 15 minutes.

Intervention Type DEVICE

High ADD power somofilcon A lens

Participants will be randomized to wear high ADD power somofilcon A lens for 15 minutes.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. They are at least 18 years of age.
2. They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
3. They habitually use soft contact lenses (multifocal soft contact lenses, sphere lenses for monovision, sphere lenses for distance vision correction and spectacles for near vision correction,) and have done so for at least the past three months.
4. They have a minimum reading add of +0.75DS (based on their spectacle refraction)
5. They have spherical equivalent refractive error between +6.00 to -10.00DS at the corneal plane and refractive astigmatism of no greater than -0.75DC in each eye.
6. They are able to achieve distance HCVA of +0.10 logMAR or better in each eye.

Exclusion Criteria

1. They have an ocular disorder which would normally contra-indicate contact lens wear.
2. They have a systemic disorder which would normally contra-indicate contact lens wear.
3. They are aphakic.
4. They have had corneal refractive surgery.
5. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Berkeley

OTHER

Sponsor Role collaborator

CooperVision International Limited (CVIL)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Meng C Lin, OD, Ph.D

Role: PRINCIPAL_INVESTIGATOR

UC Berkeley

Locations

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University of California, Berkeley, CA

Berkeley, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jose Vega, OD MSc, PhD

Role: CONTACT

01-925-640-2964

Facility Contacts

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Meng C Lin, OD, Ph.D

Role: primary

Other Identifiers

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EX-MKTG-165

Identifier Type: -

Identifier Source: org_study_id

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