Performance of Two Daily Disposable Multifocal Contact Lenses

This study will compare the performance of two daily disposable multifocal soft contact lenses.

Study Overview

• Status: Recruiting
• Conditions: Presbyopia
• Intervention / Treatment: Device: Lens A (kalfilcon A); Device: Lens B (stenfilcon A)

Detailed Description

This is a double-masked, randomized, crossover, 1-week, real world dispensing study, where participants will wear two designs of daily disposable soft multifocal contact lenses for 5-7 days each.

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jose A Vega, OD,MSc,PhD; Phone Number: 9256213761; Email: jvega2@coopervision.com

Study Locations

• United States
  • California
    • Berkeley, California, United States, 94720
      • Recruiting
      • University of California, Berkeley
      • Contact: Meng C Lin, OD, PhD; Phone Number: 510-643-9252

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 participant 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, or sphere lenses for distance vision correction and spectacles for near vision correction,) and have worn lenses at least 3 days a week for at least the past six 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 HCHL visual acuity 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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lens A then Lens B; Participants will wear the Test Lenses in both eyes for one week and then cross over to the Control Lenses in both eyes for one week.	Device: Lens A (kalfilcon A); Daily disposable, soft contact lenses worn for one week
Experimental: Lens B then Lens A; Participants will wear the Control Lenses in both eyes for one week and then cross over to the Test Lenses in both eyes for one week.	Device: Lens B (stenfilcon A); Daily disposable, soft contact lenses worn for one week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Visual Acuity	High contrast high luminance (HCHL) distance binocular visual acuity (logMAR)	Through study completion, approximately 4 hours

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2026
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: February 26, 2026
• First Submitted That Met QC Criteria: February 26, 2026
• First Posted (Actual): March 3, 2026

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia
• Other Study ID Numbers: MKTG-26-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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