NCT06902584 · CooperVision International Limited (CVIL)
North American Comfilcon A Clinical Study
What this study is 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.
View original scientific 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.
Interventions
DEVICE
comfilcon A Sphere lens
2 hours of wear
DEVICE
comfilcon A Toric lens
2 hours of wear
DEVICE
comfilcon A Multifocal lens
2 hours of wear
DEVICE
comfilcon A Multifocal Toric lens
2 hours of wear
DEVICE
comfilcon A Energys lens
2 hours of wear
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 1\. Current participation in a contact lens or contact lens care product clinical trial.
Where
- Berkeley, California
- Granville, Ohio
- College, Pennsylvania
- Corpus Christi, Texas
Collaborators
Centre for Ocular Research & Education, Canada
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 27, 2025 · Source of record for eligibility and locations