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NCT Number: NCT06902584

North American Comfilcon A Clinical 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.

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Key information

Conditions

Astigmatism Ametropia Eye Diseases Presbyopia Refractive Errors

Age range

8 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Berkeley, Berkeley, California, United States

Loading trial locations.

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 after 2 hours of wear.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

comfilcon A Sphere lens

Device

2 hours of wear

comfilcon A toric lens

Device

2 hours of wear

comfilcon A Multifocal lens

Device

2 hours of wear

comfilcon A Multifocal Toric lens

Device

2 hours of wear

comfilcon A Energys lens

Device

2 hours of wear

Primary outcomes

  1. 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

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Jill Woods, MSc,MCOptom

CONTACT

[email protected]

Jose A Vega, OD,MSc,PhD

CONTACT

[email protected]

9256402964

Sponsors and collaborators

Lead sponsor

CooperVision International Limited (CVIL)

Industry

Collaborators

  • Centre for Ocular Research & Education, Canada

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 30, 2025
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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