PresbyopiaNCT07444658
Performance of Two Daily Disposable Multifocal Contact Lenses
A study testing Lens A (kalfilcon A) and Lens B (stenfilcon A) in people with Presbyopia, run by CooperVision International Limited (CVIL) at 1 site in United States.
Trial summary
This study will compare the performance of two daily disposable multifocal soft contact lenses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Presbyopia
- What is being tested?
- Lens A (kalfilcon A) and Lens B (stenfilcon A)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2026to 11 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Berkeley
Berkeley, California, 94720
About this study
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.
- Conditions
- Presbyopia
- Being tested
- Lens A (kalfilcon A), Lens B (stenfilcon A)
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Lens B (stenfilcon A) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Visual Acuity
High contrast high luminance (HCHL) distance binocular visual acuity (logMAR)
Measured: Through study completion, approximately 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start24 Feb 2026
- Primary completion11 May 2026
- Study completion11 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PresbyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- CooperVision International Limited (CVIL)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of California, Berkeley
- Responsible party
- Sponsor
- Investigators
- Meng C Lin, Principal investigator, University of Berkeley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07444658
- Sponsor's protocol ID
- MKTG-26-01
- Status last verified
- Apr 2026
- First submitted
- 26 Feb 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of Two Daily Disposable Multifocal Contact Lenses
- ClinicalTrials.gov ID
- NCT07444658
- Acronym / sponsor ID
- MKTG-26-01
- Conditions
- Presbyopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- CooperVision International Limited (CVIL)Industry (pharma, biotech, devices)
- Collaborators
- University of California, Berkeley
- Study start
- 24 Feb 2026 (actual)
- Primary completion
- 11 May 2026 (actual)
- Study completion
- 11 May 2026 (actual)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare the performance of two daily disposable multifocal soft contact lenses.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lens A then Lens B | Experimental | Device: 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 A | Experimental | Device: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lens A (kalfilcon A)Daily disposable, soft contact lenses worn for one week | Device | Lens A then Lens B |
| Lens B (stenfilcon A)Daily disposable, soft contact lenses worn for one week | Device | Lens B then Lens A |
Primary outcome
Subjective Visual Acuity
Time frame: Through study completion, approximately 4 hours
High contrast high luminance (HCHL) distance binocular visual acuity (logMAR)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meng C Lin principal investigator
University of Berkeley
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lens A (kalfilcon A) and Lens B (stenfilcon A) in people with Presbyopia, run by CooperVision International Limited (CVIL) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective Visual Acuity (time frame: Through study completion, approximately 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.