MyopiaNCT06119191

Clinical Evaluation of Reusable Soft Contact Lenses

A study testing Test Lenses (comfilcon A with novel process) in people with Myopia, run by CooperVision International Limited (CVIL) at 5 sites in United States.

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

The purpose of this study was to confirm the clinical performance of a novel manufacturing process for comfilcon A contact lenses in habitual wearers over a one-month period of lens wear. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Myopia
What is being tested?: Test Lenses (comfilcon A with novel process)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 77 participants
Where: 5 sitesUnited States
Study dates: 14 Nov 2023to 1 Mar 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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Have had a self-reported oculo-visual examination in the last year.
Are at least 18 years of age and has full legal capacity to give their informed consent.
Have read and understood the informed consent letter.
Are willing and able to follow instructions and maintain the appointment schedule.
Have a contact lens spherical prescription between -0.50 D to -6.00 D (inclusive)
Are correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.

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Have spectacle cylinder of ≤ 0.75 D in both eyes.
Is a habitual comfilcon A wearer and worn a comfilcon A lens for at least one month (minimum of 8 hours a day, 5 days per week)
Currently employ the use of a peroxide or multipurpose solution cleaning and disinfecting regimen in one of the following brand names:
Bausch and Lomb BioTrue Multi-Purpose Solution
Bausch and Lomb BioTrue Hydration Plus Multi-Purpose Solution
Bausch and Lomb ReNu Advanced Formulation Multi-Purpose Solution
Alcon Opti-Free Puremoist with Hydraglyde Multi-Purpose Solution
Alcon Opti-Free Replenish Multi-Purpose Solution
Alcon Clear Care Plus Hydrogen Peroxide Solution
Acuvue RevitaLens Multi-Purpose Solution
Have clear corneas and no active ocular disease.
Have not worn habitual lenses for at least 12 hours before the baseline/screening examination
Are willing to wear the study contact lenses for at least 8 hours per day, 5 days per week

Who cannot join

Have never worn contact lenses before.
Are currently wearing daily disposable contact lenses.
Have any systemic disease affecting ocular health.
Are using any systemic or topical medications that will affect ocular health.
Have any ocular pathology or abnormality that would affect the wearing of contact lenses.
Have any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.

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Are aphakic.
Have undergone corneal refractive surgery.
Are participating in any other type of eye related clinical or research study.
Require a change in lens power from more than 1 diopter as dictated by over-refraction with their habitual lens prescription.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Clinical Research Center, UC Berkeley
Berkeley, California, 94720
Clinical Optics Research Lab at IU School of Optometry
Bloomington, Indiana, 47405
Ohio State University College of Optometry
Columbus, Ohio, 43210
ProCare Vision Center, Inc.
Granville, Ohio, 43023
SUNY College of Optometry Clinical Vision Research Center
New York, New York, 10016

Other trials in United States

About this study

Official title: Clinical Evaluation of Comfilcon A Contact Lenses

The purpose of this study was to confirm the clinical performance of a novel manufacturing process for comfilcon A contact lenses in habitual wearers over a one-month period of lens wear.

Read the detailed description

This was a prospective, multiple day, double-masked (investigator and subject), randomized, bilateral re-fit parallel arm study comparing a Test Lens against an appropriate Control Lens. Participants were randomized to wear the Test or Control lens for 30±2 days.

Conditions: Myopia
Being tested: Control Lenses (comfilcon A with current process), Test Lenses (comfilcon A with novel process)
Medical subject headings: Myopia

What participants receive

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

Control Lenses (comfilcon A with current process)Device
Daily wear lenses for 30±2 days
Test Lenses (comfilcon A with novel process)Device
Daily wear lenses for 30±2 days

Study groups in NCT06119191
Study group	Role	What they receive
Control Lenses	Experimental	Participants wore Control Lenses for 30±2 days. Receives: Device: Control Lenses (comfilcon A with current process)
Test Lenses	Experimental	Participants wore Test Lenses for 30±2 days. Receives: Device: Test Lenses (comfilcon A with novel process)

What is being measured

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

Visual Acuity
Monocular distance logMAR visual acuity at distance 4 meters under high illumination, high contrast conditions was measured at the 4 week timepoint of lens wear.
Measured: 4 weeks

Timeline

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

14 Nov 20231 Mar 2024

First posted7 Nov 2023
Study start14 Nov 2023
Primary completion1 Mar 2024
Study completion1 Mar 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 MyopiaStudies 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: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 77 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06119191
Sponsor's protocol ID: CV-23-86
Status last verified: Feb 2025
First submitted: 31 Oct 2023
Last updated: 8 Apr 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

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Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
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BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
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Clinical Performance and Outcomes After Toric Lens Transition
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Effect of IOP Lowering on Progressive HM
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Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation of Comfilcon A Contact Lenses
ClinicalTrials.gov ID: NCT06119191
Acronym / sponsor ID: CV-23-86
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 77 participants (actual)
Lead sponsor: CooperVision International Limited (CVIL)Industry (pharma, biotech, devices)
Study start: 14 Nov 2023 (actual)
Primary completion: 1 Mar 2024 (actual)
Study completion: 1 Mar 2024 (actual)
First posted: 7 Nov 2023 (actual)
Results: Posted 26 Mar 2025

Clinical summary

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

The purpose of this study was to confirm the clinical performance of a novel manufacturing process for comfilcon A contact lenses in habitual wearers over a one-month period of lens wear.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Control Lenses	Experimental	Device: Control Lenses (comfilcon A with current process)Participants wore Control Lenses for 30±2 days.
Test Lenses	Experimental	Device: Test Lenses (comfilcon A with novel process)Participants wore Test Lenses for 30±2 days.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (19 listed)

Have had a self-reported oculo-visual examination in the last year.
Are at least 18 years of age and has full legal capacity to give their informed consent.
Have read and understood the informed consent letter.
Are willing and able to follow instructions and maintain the appointment schedule.
Have a contact lens spherical prescription between -0.50 D to -6.00 D (inclusive)

Key exclusion criteria (10 listed)

Have never worn contact lenses before.
Are currently wearing daily disposable contact lenses.
Have any systemic disease affecting ocular health.
Are using any systemic or topical medications that will affect ocular health.
Have any ocular pathology or abnormality that would affect the wearing of contact lenses.

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 Lenses (comfilcon A with current process)Daily wear lenses for 30±2 days	Device	Control Lenses
Test Lenses (comfilcon A with novel process)Daily wear lenses for 30±2 days	Device	Test Lenses

Primary outcome

Visual Acuity
Time frame: 4 weeks
Monocular distance logMAR visual acuity at distance 4 meters under high illumination, high contrast conditions was measured at the 4 week timepoint of lens wear.

Results and safety

Results posted to the registry on 26 Mar 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 Lenses	26	25
Test Lenses	48	47

Primary outcome: Visual Acuity

Time frame: 4 weeks. Mean (Standard Deviation). Unit: logMAR

Measure	Control Lenses n = 25	Test Lenses n = 47
Value	-0.07 (0.08)	-0.13 (0.08)

Population analysed: Analysis population includes all participants that were eligible (inclusion/exclusion criteria) and completed all study visits.

Adverse events

Time frame: Length of study, approximately 30±2 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control Lenses	0 of 26 (0%)	0 of 26 (0%)	0 of 26
Test Lenses	0 of 48 (0%)	1 of 48 (2.1%)	0 of 48

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Myopia

Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia

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, OD PhD principal investigator

Clinical Research Center, UC Berkeley

Josianne Manasse, OD principal investigator

SUNY College of Optometry Clinical Vision Research Center

Peter Kollbaum, OD PhD principal investigator

Clinical Optics Research Lab at IU School of Optometry

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Test Lenses (comfilcon A with novel process) in people with Myopia, run by CooperVision International Limited (CVIL) at 5 sites 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 19 inclusion and 10 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 8 Apr 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. 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 26 Mar 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?

Visual Acuity (time frame: 4 weeks). 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 NCT06119191.

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 8 Apr 2025.