Evaluation of comfilcon A contact lenses for vision correction

North American Comfilcon A Clinical Study

This study is testing different types of comfilcon A contact lenses to see how safe and effective they are for people aged 8 to 75 after wearing them for two hours.

Quick facts

• Study type: Observational
• Enrollment: 182 (estimated)
• Ages: 8 Years to 75 Years
• Sex: All
• Sponsor: CooperVision International Limited (CVIL) (industry)
• Locations: 4 sites (Berkeley, California and 3 other locations)
• Trial ID: NCT06902584 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the safety and effectiveness of various comfilcon A contact lenses, including Sphere, Toric, Multifocal, Toric Multifocal, and Energys lenses, in the general population after two hours of wear. Participants aged 8 to 75 years who have been wearing these lenses for at least 12 months will be included. The study will monitor the performance of these lenses to ensure they meet acceptable safety standards. The research is sponsored by CooperVision International Limited in collaboration with the Centre for Ocular Research & Education.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 8 to 75 who have been wearing comfilcon A contact lenses for at least a year.

Not a fit: Patients currently participating in other contact lens clinical trials may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide patients with improved options for vision correction through enhanced contact lens technology.

How similar studies have performed: Previous studies on contact lens safety and effectiveness have shown promising results, indicating that this approach is supported by existing research.

Eligibility criteria

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.

Where this trial is running

Berkeley, California and 3 other locations

• University of Berkeley — Berkeley, California, United States (RECRUITING)
• ProCare Vision Center — Granville, Ohio, United States (RECRUITING)
• Nittany Eye Associates — College, Pennsylvania, United States (RECRUITING)
• Drs. McIntyre, Garza, Avila and Jurica, Optometrists — Corpus Christi, Texas, United States (RECRUITING)

Study contacts

• Principal investigator: Meng C Lin, OD, PhD — University of Berkeley
• Study coordinator: Jose A Vega, OD,MSc,PhD

Conditions: Astigmatism, Presbyopia, Ametropia