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

CooperVision International Limited (CVIL)

Status: Enrolling

Conditions: Myopia; Presbyopia; Hyperopia

Treatments: Device: omafilcon A lens; Device: Low ADD power somofilcon A lens; Device: High ADD power somofilcon A lens; Device: Medium ADD power somofilcon A lens

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06869044

EX-MKTG-165

Details and patient eligibility

About

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

Full description

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.

Enrollment: 66 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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66 participants in 3 patient groups

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

Experimental group

Description:

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

Treatment:

Device: Low ADD power somofilcon A lens

Device: omafilcon A lens

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

Experimental group

Description:

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

Treatment:

Device: Medium ADD power somofilcon A lens

Device: omafilcon A lens

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

Experimental group

Description:

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

Treatment:

Device: High ADD power somofilcon A lens

Device: omafilcon A lens