Recruiting

Comfilcon A

Sponsor:

CooperVision International Limited (CVIL)

Code:

NCT06902584

Conditions

Astigmatism

Presbyopia

Ametropia

Eligibility Criteria

Sex: All

Age: 8 - 70+

Healthy Volunteers: Not accepted

Interventions

comfilcon A Sphere lens

comfilcon A Toric lens

comfilcon A Multifocal lens

comfilcon A Multifocal Toric lens

comfilcon A Energys lens

Study Details

Brief 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.

Conditions

Astigmatism

Presbyopia

Ametropia

Study ID

NCT06902584

Start date

Feb 5, 2025

Status verified date

Aug, 2025

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 70+

Healthy Volunteers: Not accepted

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:

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

Study Design

Enrollment

182 participants

Anticipated

Interventions and Outcome Measures

Arms

comfilcon A Sphere Lens Wearers

Habitual comfilcon A Sphere Lens Wearers

comfilcon A Toric Lens Wearers

Habitual comfilcon A Toric Lens Wearers

comfilcon A Multifocal Lens Wearers

Habitual comfilcon A Multifocal Lens Wearers

comfilcon A Multifocal Toric Lens Wearers

Habitual comfilcon A Multifocal Toric Lens Wearers

comfilcon A Energys Lens Wearers

Habitual comfilcon A Energys Lens Wearers

Interventions

comfilcon A Sphere lens

2 hours of wear

comfilcon A Toric lens

2 hours of wear

comfilcon A Multifocal lens

2 hours of wear

comfilcon A Multifocal Toric lens

2 hours of wear

comfilcon A Energys lens

2 hours of wear

Primary outcome measure

  • Visual Performance (Visual Acuity) [ Time Frame: At the end of 2 hours of wear ]
  • Incidence of contact lens-related adverse events [ Time Frame: At the end of 2 hours of wear ]

Central Contacts and Locations

Central contacts

Jose A Vega, OD,MSc,PhD

9256402964jvega2@coopervision.com

Jill Woods, MSc,MCOptom

jwoods@uwaterloo.ca

Locations

University of Berkeley

Recruiting

Berkeley, California, United States, 94720

ProCare Vision Center

Recruiting

Granville, Ohio, United States, 43023

Nittany Eye Associates

Recruiting

College, Pennsylvania, United States, 16801

Drs. McIntyre, Garza, Avila and Jurica, Optometrists

Recruiting

Corpus Christi, Texas, United States, 78411

More Information

Sponsor

CooperVision International Limited (CVIL)

Last update posted

Aug 27, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by CooperVision International Limited (CVIL) on 2025-08-27.