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CompletedNCT06902584Updated Nov 4, 2026

North American Comfilcon A Clinical Study

An observational study in Astigmatism, Presbyopia and Ametropia, sponsored by CooperVision International Limited (CVIL). Completed at 4 sites in United States. Open to participants aged 8 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by CooperVision International Limited (CVIL) (part of CooperCompanies) · Observational

Updated Nov 4, 2026Now CompletedStart date moved+1 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
102
Ages
8 Years to 75 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Astigmatism
  • Presbyopia
  • Ametropia
03

In context

Astigmatism

417 studies on the registry are indexed under Astigmatism; 50 are open to participants now.

This study's enrollment of 102 is close to the median of 100 across 82 observational studies indexed under Astigmatism.

Browse Astigmatism studies →

Lead sponsor

CooperVision International Limited (CVIL) is the lead sponsor of 138 studies on the registry; 6 are open to participants now.

Of its 74 completed or terminated interventional studies of FDA-regulated products, 66 (89%) have results posted.

Browse CooperVision International Limited (CVIL) studies →All CooperCompanies studies →

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

04

Who can participate

Ages eligible
8 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age 8 to 75 years (inclusive).
  2. Current wearer of the Comfilcon A sphere, toric, multifocal, toric multifocal or Energys contact lens for at least 12 months.
  3. At least occasional overnight wear in the last 12 months.

Exclusion criteria

Exclusion Criteria:

1. Current participation in a contact lens or contact lens care product clinical trial.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
102 participants (actual)
Patient registry
No

Groups and cohorts

  • comfilcon A Sphere Lens Wearers

    Habitual comfilcon A Sphere Lens Wearers

    Device: comfilcon A Sphere lens

  • comfilcon A Toric Lens Wearers

    Habitual comfilcon A Toric Lens Wearers

    Device: comfilcon A Toric lens

  • comfilcon A Multifocal Lens Wearers

    Habitual comfilcon A Multifocal Lens Wearers

    Device: comfilcon A Multifocal lens

  • comfilcon A Multifocal Toric Lens Wearers

    Habitual comfilcon A Multifocal Toric Lens Wearers

    Device: comfilcon A Multifocal Toric lens

  • comfilcon A Energys Lens Wearers

    Habitual comfilcon A Energys Lens Wearers

    Device: comfilcon A Energys lens

Interventions

  • Devicecomfilcon A Sphere lens

    2 hours of wear

  • Devicecomfilcon A Toric lens

    2 hours of wear

  • Devicecomfilcon A Multifocal lens

    2 hours of wear

  • Devicecomfilcon A Multifocal Toric lens

    2 hours of wear

  • Devicecomfilcon A Energys lens

    2 hours of wear

06

What researchers measure

Primary outcomes

  1. Visual Performance (Visual Acuity)

    Visual Performance will be measured using logMAR * High contrast, high illumination distance VA * High contrast, high illumination near VA

    Time frame: At the end of 2 hours of wear

  2. Incidence of contact lens-related adverse events

    Incidence of contact lens-related adverse events will be recorded from subjects

    Time frame: At the end of 2 hours of wear

07

Study locations

4 sites
  • University of Berkeley
    Berkeley, California 94720, United States
  • ProCare Vision Center
    Granville, Ohio 43023, United States
  • Nittany Eye Associates
    College, Pennsylvania 16801, United States
  • Drs. McIntyre, Garza, Avila and Jurica, Optometrists
    Corpus Christi, Texas 78411, United States
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2025 to primary completion in Dec 2025, 11 months.

Of 35 observational studies under Astigmatism, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 92. This study's 11 months is below that.

Start moved once since we started tracking on Sep 25, 2026: Feb 2025 → Jan 2025, on Nov 4, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Mar 11, 2025
First posted
Mar 30, 2025
StartActual
Jan 31, 2025was Feb 2025
Primary completionActual
Dec 31, 2025
CompletionActual
Dec 31, 2025
Last update
Nov 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Completed
changed Nov 4, 2026
Start date
Feb 5, 2025→Jan 31, 2025
Nov 4, 2026
Enrollment
182 (estimated)→102 (actual)
Nov 4, 2026
Show all 1 update
  1. Nov 4, 2026
    Recruiting→Completed
    Start date Feb 5, 2025→Jan 31, 2025
    Enrollment 182 (estimated)→102 (actual)
    + 3 other changes: verification date, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT06902584
Lead sponsor
CooperVision International Limited (CVIL)
Collaborators
Centre for Ocular Research & Education, Canada
Responsible party
Sponsor
First posted
Mar 30, 2025
Start date
Jan 31, 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025
Last update
Nov 4, 2026

Study contacts

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
David Browning, Dr.
principal investigator · Drs. McIntyre, Garza, Avila and Jurica, Optometrists

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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