North American Comfilcon A Clinical Study

CooperVision International Limited (CVIL)

Status: Enrolling

Conditions: Ametropia; Astigmatism; Presbyopia

Treatments: Device: comfilcon A Multifocal Toric lens; Device: comfilcon A Energys lens; Device: comfilcon A Toric lens; Device: comfilcon A Multifocal lens; Device: comfilcon A Sphere lens

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06902584

CV-24-19

Details and patient eligibility

About

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.

Full 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.

Enrollment: 182 estimated patients

Sex: All

Ages: 8 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

182 participants in 5 patient groups

comfilcon A Sphere Lens Wearers

Description:

Habitual comfilcon A Sphere Lens Wearers

Treatment:

Device: comfilcon A Sphere lens

comfilcon A Toric Lens Wearers

Description:

Habitual comfilcon A Toric Lens Wearers

Treatment:

Device: comfilcon A Toric lens

comfilcon A Multifocal Lens Wearers

Description:

Habitual comfilcon A Multifocal Lens Wearers

Treatment:

Device: comfilcon A Multifocal lens

comfilcon A Multifocal Toric Lens Wearers

Description:

Habitual comfilcon A Multifocal Toric Lens Wearers

Treatment:

Device: comfilcon A Multifocal Toric lens

comfilcon A Energys Lens Wearers

Description:

Habitual comfilcon A Energys Lens Wearers

Treatment:

Device: comfilcon A Energys lens