Trials / Completed
CompletedNCT03937882
Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-3
A Multi-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of RGN-259 Ophthalmic Solutions for the Treatment of Dry Eye (ARISE-3)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 700 (actual)
- Sponsor
- ReGenTree, LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to compare the safety and efficacy of RGN-259 Ophthalmic Solution to placebo for the treatment of the signs and symptoms of dry eye.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | RGN-259 | A preservative-free, sterile eye drop solution containing Thymosin beta 4 for direct instillation into each eye, four times a day (QID) for 14 days |
| DRUG | Placebo | It is composed of the same excipients as RGN-259 but does not contain Thymosin beta 4 |
Timeline
- Start date
- 2019-05-24
- Primary completion
- 2020-11-08
- Completion
- 2021-10-07
- First posted
- 2019-05-06
- Last updated
- 2022-05-09
Locations
20 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03937882. Inclusion in this directory is not an endorsement.