Trials / Completed
CompletedNCT06119191
Clinical Evaluation of Reusable Soft Contact Lenses
Clinical Evaluation of Comfilcon A Contact Lenses
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 77 (actual)
- Sponsor
- CooperVision International Limited (CVIL) · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study was to confirm the clinical performance of a novel manufacturing process for comfilcon A contact lenses in habitual wearers over a one-month period of lens wear.
Detailed description
This was a prospective, multiple day, double-masked (investigator and subject), randomized, bilateral re-fit parallel arm study comparing a Test Lens against an appropriate Control Lens. Participants were randomized to wear the Test or Control lens for 30±2 days.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Control Lenses (comfilcon A with current process) | Daily wear lenses for 30±2 days |
| DEVICE | Test Lenses (comfilcon A with novel process) | Daily wear lenses for 30±2 days |
Timeline
- Start date
- 2023-11-14
- Primary completion
- 2024-03-01
- Completion
- 2024-03-01
- First posted
- 2023-11-07
- Last updated
- 2025-04-08
- Results posted
- 2025-03-26
Locations
5 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06119191. Inclusion in this directory is not an endorsement.