Trials / Completed
CompletedNCT04022382
A Study to Evaluate the Safety and Effectiveness Assessments of Restylane-Defyne for Punctual Occlusion
A Single-Arm, Single-Center, Randomized, Single-Masked Study to Evaluate Restylane-Defyne for Punctal Occlusion in Participants With Mild to Moderate Dry Eye Disease
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 17 (actual)
- Sponsor
- John C Meyer, MD · Academic / Other
- Sex
- All
- Age
- 21 Years – 80 Years
- Healthy volunteers
- Accepted
Summary
A study which participants with mild to moderate dry eye disease will have a punctum of one eye injected with 0.1ml Restylane Defyne and the other eye injected with 0.2ml Restylane Defyne. 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
- 2019-07-18
- Primary completion
- 2019-08-26
- Completion
- 2019-08-26
- First posted
- 2019-07-17
- Last updated
- 2019-09-06
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04022382. Inclusion in this directory is not an endorsement.