A Contralateral Dispensing Clinical Trial of Study Test Sapphire Lens Against Enfilcon A Silicone Hydrogel Lens
NCT02518490 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2020-09-22
Summary
This was be a randomized, contralateral, double-masked, dispensing study comparing the Study test lens against the control lens over one month of lens wear.
The study results were not used for design validation of test lens.
Conditions
- Myopia
Interventions
- DEVICE
-
Sapphire Lens
Each subject will be randomized to wear the test lens on one eye and control lens on one eye.
- DEVICE
-
enfilcon A
Each subject will be randomized to wear the test lens on one eye and control lens on one eye.
Sponsors & Collaborators
-
CooperVision, Inc.
lead INDUSTRY
Principal Investigators
-
Meng Lin · Clinical Research Center, University of California, Berkeley
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-08-31
- Primary Completion
- 2015-09-30
- Completion
- 2015-10-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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