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

A Clinical Comparison of Two Soft Multifocal Contact Lenses - Proclear® 1 Day Multifocal and Clariti® 1 Day Multifocal 3 Add

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

Study Overview

• Status: Completed
• Conditions: Presbyopia; Myopia; Hyperopia
• Intervention / Treatment: Device: omafilcon A lens; Device: Low ADD power somofilcon A lens; Device: Medium ADD power somofilcon A lens; Device: High ADD power somofilcon A lens

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Berkeley, California, United States, 94720
      • University of California, Berkeley, CA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: omafilcon A lens; Participants will be randomized to wear omafilcon A lens for 15 minutes.; Device: Low ADD power somofilcon A lens; Participants will be randomized to wear low ADD power somofilcon A lens for 15 minutes.
Experimental: 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.	Device: omafilcon A lens; Participants will be randomized to wear omafilcon A lens for 15 minutes.; Device: Medium ADD power somofilcon A lens; Participants will be randomized to wear medium ADD power somofilcon A lens for 15 minutes.
Experimental: 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.	Device: omafilcon A lens; Participants will be randomized to wear omafilcon A lens for 15 minutes.; Device: High ADD power somofilcon A lens; Participants will be randomized to wear high ADD power somofilcon A lens for 15 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: CooperVision International Limited (CVIL)
• Collaborators: University of California, Berkeley
• Investigators: Principal Investigator: Meng C Lin, OD, Ph.D, UC Berkeley

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2025
• Primary Completion (Actual): June 26, 2025
• Study Completion (Actual): June 26, 2025

Study Registration Dates

• First Submitted: March 5, 2025
• First Submitted That Met QC Criteria: March 5, 2025
• First Posted (Actual): March 11, 2025

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia; Hyperopia; Presbyopia
• Other Study ID Numbers: EX-MKTG-165

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes