CompletedNCT06119191Updated Apr 8, 2025Results posted

Clinical Evaluation of Reusable Soft Contact Lenses

An interventional study of Control Lenses (comfilcon A with current process) and Test Lenses (comfilcon A with novel process) in Myopia, sponsored by CooperVision International Limited (CVIL). Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-08.

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

Phase: Not applicable
Study type: Interventional
Enrollment: 77
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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 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 studied

Myopia

Browse trials for

Myopia 984

In context

Myopia

984 studies on the registry are indexed under Myopia; 210 are open to participants now.

This study's enrollment of 77 is close to the median of 80 across 783 interventional studies indexed under Myopia.

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Lead sponsor

CooperVision International Limited (CVIL) is the lead sponsor of 138 studies on the registry; 9 are open to participants now.

Of its 72 completed or terminated interventional studies of FDA-regulated products, 67 (93%) have results posted.

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

Who can participate

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

Inclusion criteria

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.
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

Exclusion criteria

Exclusion Criteria:

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.
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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 77 participants (actual)

Study arms

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

Interventions

DeviceControl Lenses (comfilcon A with current process)
Daily wear lenses for 30±2 days
DeviceTest Lenses (comfilcon A with novel process)
Daily wear lenses for 30±2 days

What researchers measure

Primary outcomes

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.
Time frame: 4 weeks

Results

Posted Mar 26, 2025

Participant flow

Participant flow — Overall Study
Milestone	Control Lenses	Test Lenses
Started	26	48
Completed	25	47
Not completed	1	1
Withdrew: Adverse event	0	1
Withdrew: Protocol violation	1	0

Outcome measures

PrimaryVisual 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.

Time frame:: 4 weeks
Reported as:: Mean · logMAR

Visual Acuity
logMAR	Control Lenses	Test Lenses
Visual Acuity	-0.07 ± 0.08	-0.13 ± 0.08

Adverse events

Collected over Length of study, approximately 30±2 days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Control Lenses	0/26 (0%)	0/26 (0%)	0/26 (0%)
Test Lenses	0/48 (0%)	0/48 (0%)	1/48 (2.1%)

Most frequent other events

Most frequent other events
Event	Control Lenses	Test Lenses
Ocular Hyperemia and DiscomfortEye disorders	0/26	1/48

Baseline characteristics

All participants that were dispensed intervention (Control or Test Lens) and completed the study

Age, Continuous
Age, Continuous(years)	Control Lenses	Test Lenses	Total
Mean	30.6 ± 11.0	29.0 ± 8.5	29.5 ± 9.4

Sex: Female, Male
Sex: Female, Male(Participants)	Control Lenses	Test Lenses	Total
Female	21	29	50
Male	4	18	22

Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)	Control Lenses	Test Lenses	Total
Count of participants	—	—	0

Study locations

5 sites

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

References and documents

Study documents

Protocol and statistical analysis plan · Nov 2, 2023

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06119191
Lead sponsor: CooperVision International Limited (CVIL)
Responsible party: Sponsor
First posted: Nov 7, 2023
Start date: Nov 14, 2023
Primary completion: Mar 1, 2024
Completion: Mar 1, 2024
Results posted: Mar 26, 2025
Last update: Apr 8, 2025

Study contacts

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

Katherine Bickle, OD

principal investigator · ProCare Vision Center, Inc.

Jennifer S Fogt, OD MS

principal investigator · Ohio State University

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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