PresbyopiaNCT06232590

Performance Comparison of Two Monthly Replacement Silicone Hydrogel Multifocal Lens Types

A study testing Test Lens (lehfilcon A) in people with Presbyopia, run by CooperVision International Limited (CVIL) at 5 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To evaluate and compare the performance of two monthly replacement multifocal contact lenses in existing wearers. Read more about this study

Who is it for?: Ages 42 years and older
Conditions the study is for: Presbyopia
What is being tested?: Test Lens (lehfilcon A)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 5 sitesin 2 countries
Study dates: 23 Feb 2024to 9 Jul 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 42 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Were at least 42 years of age and had full legal capacity to volunteer;
Had read and signed an information consent letter;
Self-reported having had a full eye examination in the previous two years;
Anticipated being able to wear the study lenses for at least 8 hours a day, 5 days a week;
Were willing and able to follow instructions and maintain the appointment schedule;
Habitually wore spherical multifocal soft contact lenses, for the past 3 months minimum:

Show all 12Show fewer

Maximum of 4 participants (out of 12) per site could be habitual wearers of daily disposable lenses,
Maximum of 4 participants (out of 12) per site could be habitual wearers of Biofinity Multifocal,
Maximum of 4 participants (out of 12) per site could be habitual wearers of either TOTAL30 Multifocal or AirOptix plus HydraGlyde Multifocal
Had refractive astigmatism no higher than -0.75DC;
Is presbyopic and requires a reading addition of at least +0.75D and no more than +2.50D;
Could be fit and achieve binocular distance vision of at least 20/30 Snellen which participants also deem to be 'acceptable', with the available study lens parameters (Distance sphere +4 to -6; near addition as per study design).

Who cannot join

Were participating in any concurrent clinical or research study;
Had any known active ocular disease and/or infection that contraindicated contact lens wear;
Had a systemic or ocular condition that in the opinion of the investigator may have affected a study outcome variable;
Were using any systemic or topical medications that in the opinion of the investigator may have affect contact lens wear or a study outcome variable;
Had known sensitivity to the diagnostic sodium fluorescein used in the study;
Self-reported as pregnant, lactating or planning a pregnancy at the time of enrolment;
Had undergone refractive error surgery or intraocular surgery.

Trial locations and contacts

5 sites in 2 countries.

Country

City, postcode or hospital

5 sites in 2 countries

United States4 sites

ProCare Vision Center
Granville, Ohio, 43023
Complete Eye Care of Medina
Medina, Minnesota, 55364
New Bremen EyeCare
New Bremen, Ohio, 45869
Sacco Eye Group
Vestal, New York, 13850

Other trials in United States

Canada1 site

Spadina Optometry
Toronto, Ontario, M5V 3E7

Other trials in Canada

About this study

To evaluate and compare the performance of two monthly replacement multifocal contact lenses in existing wearers.

Read the detailed description

This was a prospective, randomized, participant-masked, crossover, bilateral dispensing study. Each lens type was worn for approximately 4-6 weeks: the lens prescription of each lens type was optimized after 3-10 days wearing experience, prior to starting a 1-month (28-32 days) wear period.

Conditions: Presbyopia
Being tested: Control Lens (comfilcon A), Test Lens (lehfilcon A)
Medical subject headings: Presbyopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Control Lens (comfilcon A)Device
Multifocal monthly replacement contact lens for 1 month
Test Lens (lehfilcon A)Device
Multifocal monthly replacement contact lens for 1 month

Study groups in NCT06232590
Study group	Role	What they receive
Control Lens, then Test Lens	Experimental	Participants wore Control Lens for 1 month, then the Test Lens for 1 month Receives: Device: Control Lens (comfilcon A); Device: Test Lens (lehfilcon A)
Test Lens, then Control Lens	Experimental	Participants wore the Test Lens for 1 month, then the Control Lens for 1 month Receives: Device: Control Lens (comfilcon A); Device: Test Lens (lehfilcon A)

What is being measured

The primary outcome is the main question the study is designed to answer.

Lens Handling for Insertion
Subjective rating collected in office using a 0-100 scale, where 0=Very difficult and 100=Very easy. The participant rated the study lens considering a typical day in the last 1 month of wear.
Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Feb 20249 Jul 2024

First posted31 Jan 2024
Study start23 Feb 2024
Primary completion9 Jul 2024
Study completion9 Jul 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Single blind
Who is masked: Participant
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06232590
Sponsor's protocol ID: EX-MKTG-153
Status last verified: Nov 2024
First submitted: 22 Jan 2024
Last updated: 12 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Evaluation of Functional Superiority of the Morrow eProgressive
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Active, not recruiting
Clinical Trial With Artiflex Presbyopic (Artiplus)
Presbyopia, Ametropia
Recruiting
VisDura VisAbility™ Micro Insert System Pre-market Clinical Trial
Presbyopia
Recruiting
Volumetric Visual Fields at Intermediate and Near Distances in Presbyopic Patients Using Occupational and General-Purpose Progressive Addition Lenses
Presbyopia
Recruiting
Volumetric Visual Fields at Different Distances in Presbyopic Patients Using Occupational (PC-133 and PC-200) and General-Purpose Progressive Addition Lenses
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All Presbyopia trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Performance Comparison of Two Monthly Replacement Silicone Hydrogel Multifocal Lens Types
ClinicalTrials.gov ID: NCT06232590
Acronym / sponsor ID: EX-MKTG-153
Conditions: Presbyopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: CooperVision International Limited (CVIL)Industry (pharma, biotech, devices)
Collaborators: Centre for Ocular Research & Education, Canada
Study start: 23 Feb 2024 (actual)
Primary completion: 9 Jul 2024 (actual)
Study completion: 9 Jul 2024 (actual)
First posted: 31 Jan 2024 (actual)
Results: Posted 12 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To evaluate and compare the performance of two monthly replacement multifocal contact lenses in existing wearers.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Control Lens, then Test Lens	Experimental	Device: Control Lens (comfilcon A), Device: Test Lens (lehfilcon A)Participants wore Control Lens for 1 month, then the Test Lens for 1 month
Test Lens, then Control Lens	Experimental	Device: Control Lens (comfilcon A), Device: Test Lens (lehfilcon A)Participants wore the Test Lens for 1 month, then the Control Lens for 1 month

Who may qualify

Ages: 42 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Were at least 42 years of age and had full legal capacity to volunteer;
Had read and signed an information consent letter;
Self-reported having had a full eye examination in the previous two years;
Anticipated being able to wear the study lenses for at least 8 hours a day, 5 days a week;
Were willing and able to follow instructions and maintain the appointment schedule;

Key exclusion criteria (7 listed)

Were participating in any concurrent clinical or research study;
Had any known active ocular disease and/or infection that contraindicated contact lens wear;
Had a systemic or ocular condition that in the opinion of the investigator may have affected a study outcome variable;
Were using any systemic or topical medications that in the opinion of the investigator may have affect contact lens wear or a study outcome variable;
Had known sensitivity to the diagnostic sodium fluorescein used in the study;

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
Control Lens (comfilcon A)Multifocal monthly replacement contact lens for 1 month	Device	Control Lens, then Test Lens, Test Lens, then Control Lens
Test Lens (lehfilcon A)Multifocal monthly replacement contact lens for 1 month	Device	Control Lens, then Test Lens, Test Lens, then Control Lens

Primary outcome

Lens Handling for Insertion
Time frame: 1 month
Subjective rating collected in office using a 0-100 scale, where 0=Very difficult and 100=Very easy. The participant rated the study lens considering a typical day in the last 1 month of wear.

Results and safety

Results posted to the registry on 12 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control Lens, Then Test Lens	30	30
Test Lens, Then Control Lens	30	30

Primary outcome: Lens Handling for Insertion

Time frame: 1 month. Mean (Standard Deviation). Unit: score on a scale

Measure	Control Lens n = 59	Test Lens n = 59
Value	95 (9)	96 (8)

Adverse events

Time frame: Length of study, approximately 3 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control Lens	0 of 60 (0%)	4 of 60 (6.7%)	0 of 60
Test Lens	0 of 59 (0%)	4 of 59 (6.8%)	0 of 59

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Presbyopia

Recruiting
Evaluation of Functional Superiority of the Morrow eProgressive
Presbyopia
Active, not recruiting
Clinical Trial With Artiflex Presbyopic (Artiplus)
Presbyopia, Ametropia
Recruiting
VisDura VisAbility™ Micro Insert System Pre-market Clinical Trial
Presbyopia
Recruiting
Volumetric Visual Fields at Intermediate and Near Distances in Presbyopic Patients Using Occupational and General-Purpose Progressive Addition Lenses
Presbyopia
Recruiting
Volumetric Visual Fields at Different Distances in Presbyopic Patients Using Occupational (PC-133 and PC-200) and General-Purpose Progressive Addition Lenses
Presbyopia

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.

Andrew Sacco principal investigator

Sacco Eye Group

David Wilkinson principal investigator

Spadina Optometry

Katherine Bickle principal investigator

ProCare Vision Center

5 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Test Lens (lehfilcon A) in people with Presbyopia, run by CooperVision International Limited (CVIL) at 5 sites in 2 countries.

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 12 inclusion and 7 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 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States, Canada. 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?

Yes. Results are posted in the registry (first posted 12 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Lens Handling for Insertion (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06232590.

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 12 Feb 2025.