Trials / Completed
CompletedNCT04280653
An Open-Label, Multi-Center, Clinical Study Evaluating the Effect of the NDE L68 StableFit® Punctal Plug on the Tear Lake
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- Mati Therapeutics Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
To evaluate the effect of the NDE L68 StableFit® punctal plug on the tear lake.
Detailed description
This is a Non-Significant Risk (NSR) medical device, multi-center, open-label clinical study. Each study subject that qualifies at the baseline visit will receive an NDE L68 StableFit® punctal plug in the lower punctum in one of their eyes. All study plugs will remain in the study subject's lower punctum for a period of 28 + 4 days after insertion.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | NDE L68 StableFit® Punctal Plug | Tear lake evaluation of the planned study eye, prior to insertion of the Punctal Plug and then tear lake evaluation at days 7 and 28 after punctal plug insertion. |
Timeline
- Start date
- 2019-08-28
- Primary completion
- 2019-12-11
- Completion
- 2019-12-11
- First posted
- 2020-02-21
- Last updated
- 2020-12-08
- Results posted
- 2020-12-08
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04280653. Inclusion in this directory is not an endorsement.