Trials / Completed
CompletedNCT04024072
To Compare the Safety and Efficacy of Perrigo's Product to an FDA Approved Product for the Treatment of Glaucoma or Ocular Hypertension in Both Eyes
Multi-Center, Randomized, Double-Masked, Active Controlled, Parallel Group Study to Compare Perrigo's Brinzolamide Ophthalmic Suspension 1% to Azopt® in the Treatment of Primary Open Angle Glaucoma or Ocular Hypertension in Both Eyes
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 495 (actual)
- Sponsor
- Padagis LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To compare the safety and efficacy of Perrigo's product to an FDA approved product in the treatment of Primary Open Angle Glaucoma or Ocular Hypertension in Both Eyes.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Brinzolamide 1% ophthalmic suspension | Test product |
| DRUG | Azopt 1% Ophthalmic Suspension | Reference product |
Timeline
- Start date
- 2019-06-24
- Primary completion
- 2020-02-26
- Completion
- 2020-04-30
- First posted
- 2019-07-18
- Last updated
- 2023-03-06
- Results posted
- 2023-03-06
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04024072. Inclusion in this directory is not an endorsement.