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

NCT06869044 | Completed FDA Device

• 1 other identifier: EX-MKTG-165
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Myopia; Hyperopia; Presbyopia

Outcome Measures

Primary Outcomes (1)

• Overall lens satisfaction

  Overall Impression recorded on a visual analog scale of 0 to 100 where (0=Extremely poor. Unmanageable. Cannot use lenses, 100=Excellent. Highly impressed with these lenses overall.)

  At the end of 15 minutes wear

Study Arms (3)

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

EXPERIMENTAL

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

Device: omafilcon A lens; Device: Low ADD power somofilcon A lens

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

EXPERIMENTAL

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

Device: omafilcon A lens; Device: Medium ADD power somofilcon A lens

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

EXPERIMENTAL

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

Device: omafilcon A lens; Device: High ADD power somofilcon A lens

Interventions

High ADD power somofilcon A lens DEVICE

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

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

omafilcon A lens DEVICE

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

omafilcon A lenses first, then high ADD power somofilcon A lens; omafilcon A lenses first, then low ADD power somofilcon A lens; omafilcon A lenses first, then medium ADD power somofilcon A lens

Low ADD power somofilcon A lens DEVICE

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

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

Medium ADD power somofilcon A lens DEVICE

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• They are at least 18 years of age.
• They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
• 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.
• They have a minimum reading add of +0.75DS (based on their spectacle refraction)
• 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.
• They are able to achieve distance HCVA of +0.10 logMAR or better in each eye.

You may not qualify if:

• 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.
• They have had corneal refractive surgery.
• They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.

Sponsors & Collaborators

• CooperVision International Limited (CVIL): lead
• University of California, Berkeley: collaborator

Study Sites (1)

University of California, Berkeley, CA

Berkeley, California, 94720, United States

Location

MeSH Terms

Conditions

Myopia; Hyperopia; Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Meng C Lin, OD, Ph.D

  UC Berkeley

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 11, 2025
• Study Start: February 11, 2025
• Primary Completion: June 26, 2025
• Study Completion: June 26, 2025
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

US (1)