Performance of Two Daily Disposable Multifocal Contact Lenses

NCT07444658 — Not applicable, Recruiting, 35 participants, CooperVision International Limited (CVIL)

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  
RegistryNCT07444658
StatusRecruiting
PhaseNot applicable
Study typeInterventional; randomized, crossover, masking: double, treatment
Enrollment35 (Estimated)
SponsorCooperVision International Limited (CVIL) (Industry); collaborators: University of California, Berkeley
ConditionsPresbyopia
InterventionsLens A (kalfilcon A), Lens B (stenfilcon A) (Device)
Datesstart 2026-02-24, primary completion 2026-05-31 (estimated), completion 2026-05-31 (estimated), first posted 2026-03-03, last updated 2026-04-08
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Presbyopia All trials of Lens A (kalfilcon A) All trials of Lens B (stenfilcon A)

-Summary

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

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Lens A then Lens BExperimentalDevice: Lens A (kalfilcon A)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.
Lens B then Lens AExperimentalDevice: Lens B (stenfilcon 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.
  • Lens A (kalfilcon A) (Device): Daily disposable, soft contact lenses worn for one week
  • Lens B (stenfilcon A) (Device): Daily disposable, soft contact lenses worn for one week

+Outcome measures

Primary outcomes

  • Subjective Visual Acuity [Through study completion, approximately 4 hours]: High contrast high luminance (HCHL) distance binocular visual acuity (logMAR)

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (1)

FacilityCityCountryStatus
University of California, BerkeleyBerkeley, CaliforniaUnited StatesRecruiting

+Investigators

  • Meng C Lin, Principal investigator, University of Berkeley