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NCT04962009 · ClinicalTrials.gov registry record
Safety and Intraocular Lowering Effect of Delivery of Travoprost Evolute® in Subjects With Elevated Intraocular Pressure
A clinical trial, sponsored by Mati Therapeutics.
- Completed
- Registry status
- 12
- Enrollment target
NCT04962009: Completed study, sponsored by Mati Therapeutics.
NCT04962009 is a clinical trial that has completed, run by Mati Therapeutics. The registered enrollment target is 12 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04962009 has completed, sponsored by Mati Therapeutics.
- COMPLETED
- Registry status
- 12 participants
- Enrollment target
Study Summary
This is a pilot, open-label, multi-center clinical study. Each potential subject that has met all screening inclusion/exclusion criteria will undergo a six-week washout phase where they will discontinue the use of their topical hypotensive medication. After the six-week washout, each potential subject will return for a baseline visit. Investigators will verify that a potential subject has discontinued the use of their topical hypotensive medication(s) and all their prohibited systemic medications for the last 6 weeks. In addition, each subject will have discontinued the use of all other ocular drops, gels or ointments 24 hours prior to the visit (Visit 2) and continues to meet all screening and washout criteria. After completing the baseline examination, each potential subject that meet all baseline inclusion/exclusion for the treatment phase of the study will have his/her lower puncta of each eye inserted with a Travoprost Evolute®. Each study subject will be instructed to return to the investigator's office the next day, 7, 28, 60 and 90-days after the insertion of their plugs for follow-up examinations.
Primary Outcome
Mean percent change in Intraocular Pressure (IOP) from baseline to days 90
Interventions
- COMBINATION_PRODUCT Travoprost Evolute® (Travoprost Punctal Plug Delivery System), 166 ug
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2021-09-08 |
| Est. Completion | 2022-07-15 |
What the finished NCT04962009 record still lists
NCT04962009 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Travoprost Evolute® (Travoprost Punctal Plug Delivery System), 166 ug is the first listed.
NCT04962009 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04962009 about?
NCT04962009 is a clinical study titled "Safety and Intraocular Lowering Effect of Delivery of Travoprost Evolute® in Subjects With Elevated Intraocular Pressure". This is a pilot, open-label, multi-center clinical study. Each potential subject that has met all screening inclusion/exclusion criteria will undergo a six-week washout phase where they will discontinue the use of their topical hypotensive medication. After the six-week washout, each potential subj...
What is the current status of trial NCT04962009?
This trial is currently completed. The enrollment target is 12 participants. The study started on 2021-09-08. Estimated completion is 2022-07-15.
What interventions are being tested in trial NCT04962009?
The interventions under investigation include: Travoprost Evolute® (Travoprost Punctal Plug Delivery System), 166 ug (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT04962009?
This trial is sponsored by Mati Therapeutics, which has 12 total clinical trials registered on ClinicalTrials.gov.
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