Recruiting

Multifocal Contact Lenses

Sponsor:

CooperVision International Limited (CVIL)

Code:

NCT07444658

Conditions

Presbyopia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Lens A (kalfilcon A)

Lens B (stenfilcon A)

Study Details

Brief summary:

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

Conditions

Presbyopia

Study ID

NCT07444658

Start date

Feb 24, 2026

Status verified date

Apr, 2026

Completion date

May 31, 2026

Anticipated

Primary completion date

May 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

35 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Lens A (kalfilcon A)

Daily disposable, soft contact lenses worn for one week

Lens B (stenfilcon A)

Daily disposable, soft contact lenses worn for one week

Primary outcome measure

  • Subjective Visual Acuity [ Time Frame: Through study completion, approximately 4 hours ]

Central Contacts and Locations

Central contacts

Jose A Vega, OD,MSc,PhD

9256213761jvega2@coopervision.com

Locations

University of California, Berkeley

Recruiting

Berkeley, California, United States, 94720

Contacts

Meng C Lin, OD, PhD

510-643-9252

More Information

Sponsor

CooperVision International Limited (CVIL)

Last update posted

Apr 8, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by CooperVision International Limited (CVIL) on 2026-04-08.