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CompletedNCT07444658Updated Oct 23, 2026

Performance of Two Daily Disposable Multifocal Contact Lenses

An interventional study of Lens A (kalfilcon A) and Lens B (stenfilcon A) in Presbyopia, sponsored by CooperVision International Limited (CVIL). Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.

Sponsored by CooperVision International Limited (CVIL) (part of CooperCompanies) · Not applicable, Interventional, and Treatment

Updated Oct 23, 2026Now CompletedPrimary completion moved+2 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Presbyopia

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03

In context

Presbyopia

336 studies on the registry are indexed under Presbyopia; 35 are open to participants now.

This study's enrollment of 30 is below the median of 61 across 276 interventional studies indexed under Presbyopia.

Browse Presbyopia studies →

Lead sponsor

CooperVision International Limited (CVIL) is the lead sponsor of 138 studies on the registry; 6 are open to participants now.

Of its 74 completed or terminated interventional studies of FDA-regulated products, 66 (89%) have results posted.

Browse CooperVision International Limited (CVIL) studies →All CooperCompanies studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .
  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

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
30 participants (actual)

Study 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.

    Device: Lens A (kalfilcon A)

  • 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)

Interventions

  • DeviceLens A (kalfilcon A)

    Daily disposable, soft contact lenses worn for one week

  • DeviceLens B (stenfilcon A)

    Daily disposable, soft contact lenses worn for one week

06

What researchers measure

Primary outcomes

  1. Subjective Visual Acuity

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

    Time frame: Through study completion, approximately 4 hours

07

Study locations

1 site
  • University of California, Berkeley
    Berkeley, California 94720, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2026 to primary completion in May 2026, 2 months.

Of 87 industry-sponsored interventional studies with no phase under Presbyopia, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 19. This study's 2 months is below that.

Counting every sponsor, half of 129 studies reached it within 10 months; a quarter within 3 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 26, 2026
First posted
Mar 3, 2026
StartActual
Feb 24, 2026
Primary completionActual
May 11, 2026
CompletionActual
May 11, 2026
Last update
Oct 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Completed
changed Oct 23, 2026
Primary completion
May 31, 2026→May 11, 2026 (actual)
Oct 23, 2026
Study completion
May 31, 2026→May 11, 2026 (actual)
Oct 23, 2026
Enrollment
35 (estimated)→30 (actual)
Oct 23, 2026
Show all 1 update
  1. Oct 23, 2026
    Recruiting→Completed
    Primary completion May 31, 2026→May 11, 2026 (now actual)
    Study completion May 31, 2026→May 11, 2026 (now actual)
    Enrollment 35 (estimated)→30 (actual)
    + 2 other changes: contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07444658
Lead sponsor
CooperVision International Limited (CVIL)
Collaborators
University of California, Berkeley
Responsible party
Sponsor
First posted
Mar 3, 2026
Start date
Feb 24, 2026
Primary completion
May 11, 2026
Completion
May 11, 2026
Last update
Oct 23, 2026

Study contacts

Meng C Lin
principal investigator · University of Berkeley

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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