Trials / Completed
CompletedNCT02553681
Clinical Evaluation of HPT Treated Rigid Contact Lenses Made From Roflufocon D
Clinical Evaluation of Hydra-PEG (Polyethylene Glycol) Treatment (HPT) Treated Rigid Contact Lenses Made From Roflufocon D
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 45 (actual)
- Sponsor
- Contamac Ltd · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
This will be an up to six months, subject-masked, contralateral, parallel-group, randomised, daily wear study. All subjects will wear the Test lens in one eye and the Control lens in the other eye. Data from the first four weeks of Test and Control lens exposure will be used for the FDA 510 (k) submission.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | roflufocon D contact lenses | HPT treated rigid contact lenses |
| DEVICE | RGP contact lenses made from roflufocon D |
Timeline
- Start date
- 2015-07-01
- Primary completion
- 2017-02-01
- Completion
- 2017-02-16
- First posted
- 2015-09-17
- Last updated
- 2020-08-12
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT02553681. Inclusion in this directory is not an endorsement.