Trials / Completed
CompletedNCT03709641
A Study to Evaluate the Safety and Effectiveness of Restylane-Defyne for Punctual Occlusion
A Single-Arm, Single-Center, Randomized, Single-Masked Study to Evaluate Restylane Defyne for Canalicular Occlusion in Participants With Mild to Moderate Dry Eye Disease
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 14 (actual)
- Sponsor
- John C Meyer, MD · Academic / Other
- Sex
- All
- Age
- 21 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
A study which participants with mild to moderate dry eye disease will have a punctum of one eye injected with Restyalne Defyne and the other eye injected with saline solution. Participants will be evaluated over four visits.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Restylane Defyne | Restylane is a gel of hyaluronic acid generated by Streptococcus species of bacteria, chemically crosslinked with BDDE, stabilized and suspended in phosphate buffered saline at pH=7 and concentration of 20 mg/mL |
Timeline
- Start date
- 2018-10-17
- Primary completion
- 2018-11-28
- Completion
- 2018-11-28
- First posted
- 2018-10-17
- Last updated
- 2018-12-10
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03709641. Inclusion in this directory is not an endorsement.