Trials / Completed
CompletedNCT03450629
Evaluation of Safety and Efficacy of PDP-716
A Randomized, Multi-Center, Investigator-Masked, Parallel Group, Equivalence Study of Once Daily Brimonidine Tartrate Ophthalmic Suspension Compared With Three Times Daily ALPHAGAN-P® in Subjects With Open Angle Glaucoma, or Ocular Hypertension
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 682 (actual)
- Sponsor
- Sun Pharma Advanced Research Company Limited · Industry
- Sex
- All
- Age
- 2 Years
- Healthy volunteers
- Not accepted
Summary
The study will be conducted to evaluate the efficacy and safety of topical administration of PDP-716 compared with brimonidine tartrate ophthalmic solution.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Brimonidine Tartrate Ophthalmic Suspension | PDP-716 |
| DRUG | Brimonidine Tartrate Ophthalmic Solution | Three Times Brimonidine Tartrate Ophthalmic Solution |
Timeline
- Start date
- 2018-09-13
- Primary completion
- 2020-12-01
- Completion
- 2020-12-01
- First posted
- 2018-03-01
- Last updated
- 2022-02-15
- Results posted
- 2022-02-15
Locations
47 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03450629. Inclusion in this directory is not an endorsement.