To Compare the Efficacy and Safety of Perrigo's Product to an FDA Approved Product for the Treatment of Glaucoma or Ocular Hypertension in Both Eyes
NCT04944290 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 447
Last updated 2025-04-02
Summary
To compare the efficacy and safety of Perrigo's product to an FDA approved product in the treatment of Primary Open Angle Glaucoma or Ocular Hypertension in Both Eyes.
Conditions
- Glaucoma, Open-Angle
- Ocular Hypertension
Interventions
- DRUG
-
Brinzolamide/brimonidine ophthalmic suspension
Test product
- DRUG
-
Simbrinza 0.2%/1% Ophthalmic Suspension
Reference product
Sponsors & Collaborators
-
Padagis LLC
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-05-28
- Primary Completion
- 2022-03-11
- Completion
- 2022-06-21
- FDA Drug
- Yes
Countries
- United States
Study Locations
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