Trials / Completed
CompletedNCT03417557
Clinical Validation Study of Comfilcon A Multifocal Toric Contact Lenses
Clinical Validation Study of Biofinity Multifocal Toric Contact Lenses
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- CooperVision, Inc. · Industry
- Sex
- All
- Age
- 40 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This is a study to evaluate the clinical performance and subjective acceptance of an investigational contact lens (test), compared to a marketed lens (control) in an in-office setting.
Detailed description
This is a study to evaluate the clinical performance (including visual acuity, subjective assessments of visual performance, comfort ratings, vision preference and lens fit) of a comfilcon A investigational contact lens (test) compared to a control contact lens, in a non-dispensing setting. The main study hypothesis is the test contact lens will not be clinically inferior to the control lens.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Comfilcon A lens (test) | contact lens |
| DEVICE | Omafilcon B lens (control) | contact lens |
Timeline
- Start date
- 2018-01-12
- Primary completion
- 2018-04-03
- Completion
- 2018-04-03
- First posted
- 2018-01-31
- Last updated
- 2020-05-04
- Results posted
- 2020-05-04
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03417557. Inclusion in this directory is not an endorsement.