AstigmatismNCT06902584
North American Comfilcon A Clinical Study
An observational study of Astigmatism and Presbyopia, run by CooperVision International Limited (CVIL) at 4 sites in United States.
Trial summary
The main objective of this study is to demonstrate acceptable safety and effectiveness (performance) of comfilcon A Sphere, Toric, Multifocal, Toric Multifocal and Energys lenses, when used in the general population. Read more about this study
- Who is it for?
- Ages 8 to 75 years
- Conditions the study is for
- Astigmatism, Presbyopia, Ametropia
- What is being tested?
- comfilcon A Sphere lens, comfilcon A Toric lens and comfilcon A Multifocal lens
- Type of treatment
- Medical device
- How many people
- 182 participants
- Where
- 4 sitesUnited States
- Study dates
- 5 Feb 2025to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 8 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Female or male subjects aged 8 to 75 years who are established contact lens wearers. Screen and enrol approximately 182 participants wearing comfilcon A lenses with the aim of achieving at least 160 in the per protocol analysis cohort.
Who may be able to join
- Age 8 to 75 years (inclusive).
- Current wearer of the Comfilcon A sphere, toric, multifocal, toric multifocal or Energys contact lens for at least 12 months.
- At least occasional overnight wear in the last 12 months.
Who cannot join
- 1. Current participation in a contact lens or contact lens care product clinical trial.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Jill Woods, MSc,MCOptom contact
United States4 sites, 4 recruiting
- Recruiting
University of Berkeley
Berkeley, California, 94720
Meng C Lin, OD,PhD
- Recruiting
Nittany Eye Associates
College, Pennsylvania, 16801
Abigail G Harsch, Dr.
- Recruiting
Drs. McIntyre, Garza, Avila and Jurica, Optometrists
Corpus Christi, Texas, 78411
David Browning, Dr.
- Recruiting
ProCare Vision Center
Granville, Ohio, 43023
Katherine Bickle, Dr.
About this study
The main objective of this study is to demonstrate acceptable safety and effectiveness (performance) of comfilcon A Sphere, Toric, Multifocal, Toric Multifocal and Energys lenses, when used in the general population.
Read the detailed description
The main objective of this study is to demonstrate acceptable safety and effectiveness (performance) of comfilcon A Sphere, Toric, Multifocal, Toric Multifocal and Energys lenses, when used in the general population after 2 hours of wear.
- Conditions
- Astigmatism, Presbyopia, Ametropia
- Being tested
- comfilcon A Sphere lens, comfilcon A Toric lens, comfilcon A Multifocal lens, comfilcon A Multifocal Toric lens, comfilcon A Energys lens
- Medical subject headings
- Astigmatism, Presbyopia, Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comfilcon A Sphere lensDevice
2 hours of wear
comfilcon A Toric lensDevice
2 hours of wear
comfilcon A Multifocal lensDevice
2 hours of wear
comfilcon A Multifocal Toric lensDevice
2 hours of wear
comfilcon A Energys lensDevice
2 hours of wear
| Study group | Role | What they receive |
|---|---|---|
| comfilcon A Sphere Lens Wearers | Habitual comfilcon A Sphere Lens Wearers Receives: Device: comfilcon A Sphere lens | |
| comfilcon A Toric Lens Wearers | Habitual comfilcon A Toric Lens Wearers Receives: Device: comfilcon A Toric lens | |
| comfilcon A Multifocal Lens Wearers | Habitual comfilcon A Multifocal Lens Wearers Receives: Device: comfilcon A Multifocal lens | |
| comfilcon A Multifocal Toric Lens Wearers | Habitual comfilcon A Multifocal Toric Lens Wearers Receives: Device: comfilcon A Multifocal Toric lens | |
| comfilcon A Energys Lens Wearers | Habitual comfilcon A Energys Lens Wearers Receives: Device: comfilcon A Energys lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Performance (Visual Acuity)
Visual Performance will be measured using logMAR
- High contrast, high illumination distance VA
- High contrast, high illumination near VA
Measured: At the end of 2 hours of wear
Incidence of contact lens-related adverse events
Incidence of contact lens-related adverse events will be recorded from subjects
Measured: At the end of 2 hours of wear
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start5 Feb 2025
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AstigmatismStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CooperVision International Limited (CVIL)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centre for Ocular Research & Education, Canada
- Responsible party
- Sponsor
- Investigators
- Meng C Lin, OD, PhD, Principal investigator, University of BerkeleyKatherine Bickle, Dr., Principal investigator, ProCare Vision CenterAbigail G Harsch, Dr., Principal investigator, Nittany Eye AssociatesDavid Browning, Dr., Principal investigator, Drs. McIntyre, Garza, Avila and Jurica, Optometrists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06902584
- Sponsor's protocol ID
- CV-24-19
- Status last verified
- Aug 2025
- First submitted
- 11 Mar 2025
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- North American Comfilcon A Clinical Study
- ClinicalTrials.gov ID
- NCT06902584
- Acronym / sponsor ID
- CV-24-19
- Conditions
- Astigmatism, Presbyopia, Ametropia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- CooperVision International Limited (CVIL)Industry (pharma, biotech, devices)
- Collaborators
- Centre for Ocular Research & Education, Canada
- Study start
- 5 Feb 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 30 Mar 2025 (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.
The main objective of this study is to demonstrate acceptable safety and effectiveness (performance) of comfilcon A Sphere, Toric, Multifocal, Toric Multifocal and Energys lenses, when used in the general population.
Detailed description
The main objective of this study is to demonstrate acceptable safety and effectiveness (performance) of comfilcon A Sphere, Toric, Multifocal, Toric Multifocal and Energys lenses, when used in the general population after 2 hours of wear.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| comfilcon A Sphere Lens Wearers | – | Device: comfilcon A Sphere lensHabitual comfilcon A Sphere Lens Wearers |
| comfilcon A Toric Lens Wearers | – | Device: comfilcon A Toric lensHabitual comfilcon A Toric Lens Wearers |
| comfilcon A Multifocal Lens Wearers | – | Device: comfilcon A Multifocal lensHabitual comfilcon A Multifocal Lens Wearers |
| comfilcon A Multifocal Toric Lens Wearers | – | Device: comfilcon A Multifocal Toric lensHabitual comfilcon A Multifocal Toric Lens Wearers |
| comfilcon A Energys Lens Wearers | – | Device: comfilcon A Energys lensHabitual comfilcon A Energys Lens Wearers |
Who may qualify
- Ages
- 8 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Female or male subjects aged 8 to 75 years who are established contact lens wearers. Screen and enrol approximately 182 participants wearing comfilcon A lenses with the aim of achieving at least 160 in the per protocol analysis cohort.
Key inclusion criteria (3 listed)
- Age 8 to 75 years (inclusive).
- Current wearer of the Comfilcon A sphere, toric, multifocal, toric multifocal or Energys contact lens for at least 12 months.
- At least occasional overnight wear in the last 12 months.
Key exclusion criteria (1 listed)
- 1. Current participation in a contact lens or contact lens care product clinical trial.
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 |
|---|---|---|
| comfilcon A Sphere lens2 hours of wear | Device | comfilcon A Sphere Lens Wearers |
| comfilcon A Toric lens2 hours of wear | Device | comfilcon A Toric Lens Wearers |
| comfilcon A Multifocal lens2 hours of wear | Device | comfilcon A Multifocal Lens Wearers |
| comfilcon A Multifocal Toric lens2 hours of wear | Device | comfilcon A Multifocal Toric Lens Wearers |
| comfilcon A Energys lens2 hours of wear | Device | comfilcon A Energys Lens Wearers |
Primary outcome
Visual Performance (Visual Acuity)
Time frame: At the end of 2 hours of wear
Visual Performance will be measured using logMAR * High contrast, high illumination distance VA * High contrast, high illumination near VA
Incidence of contact lens-related adverse events
Time frame: At the end of 2 hours of wear
Incidence of contact lens-related adverse events will be recorded from subjects
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
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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.
Jill Woods, MSc,MCOptom contact
Meng C Lin, OD, PhD principal investigator
University of Berkeley
Katherine Bickle, Dr. principal investigator
ProCare Vision Center
Abigail G Harsch, Dr. principal investigator
Nittany Eye Associates
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Astigmatism and Presbyopia, run by CooperVision International Limited (CVIL) at 4 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 3 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jose A Vega, OD,MSc,PhD (9256402964, jvega2@coopervision.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Performance (Visual Acuity) (time frame: At the end of 2 hours of wear). The study lists 2 primary outcomes in all. 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 27 Aug 2025.