Performance of Two Daily Disposable Multifocal Contact Lenses

NCT07444658 | Recruiting FDA Device

• 1 other identifier: MKTG-26-01
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Presbyopia

Outcome Measures

Primary Outcomes (1)

• Subjective Visual Acuity

  High contrast high luminance (HCHL) distance binocular visual acuity (logMAR)

  Through study completion, approximately 4 hours

Study Arms (2)

Lens A then Lens B

EXPERIMENTAL

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)

Lens B then Lens A

EXPERIMENTAL

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)

Interventions

Lens A (kalfilcon A) DEVICE

Daily disposable, soft contact lenses worn for one week

Lens A then Lens B

Lens B (stenfilcon A) DEVICE

Daily disposable, soft contact lenses worn for one week

Lens B then Lens A

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 participant 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, 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.
• 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 HCHL visual acuity 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

Berkeley, California, 94720, United States

RECRUITING

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Meng C Lin

  University of Berkeley

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jose A Vega, OD,MSc,PhD

CONTACT

9256213761; jvega2@coopervision.com

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: February 26, 2026
• First Posted: March 3, 2026
• Study Start: February 24, 2026
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)