NCT04944290

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

Multi-Center, Randomized, Double-Masked, Active Controlled, Parallel Group Study to Compare Perrigo's Brinzolamide/Brimonidine Ophthalmic Suspension 1% to Simbrinza® in the Treatment of Primary Open Angle Glaucoma or Ocular Hypertension in Both Eyes

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 447 (actual)
• Sponsor: Padagis LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Brinzolamide/brimonidine ophthalmic suspension	Test product
DRUG	Simbrinza 0.2%/1% Ophthalmic Suspension	Reference product

Timeline

• Start date: 2021-05-28
• Primary completion: 2022-03-11
• Completion: 2022-06-21
• First posted: 2021-06-29
• Last updated: 2025-04-02
• Results posted: 2025-04-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study