NCT05022004

A Therapeutic Equivalence Study in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension

Therapeutic Equivalence Study of Generic Brinzolamide 1% Ophthalmic Suspension Compared to Reference Listed Drug Azopt® (Brinzolamide) Ophthalmic Suspension 1% in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 599 (actual)
• Sponsor: Sun Pharmaceutical Industries Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, Investigator-masked, multi-center, parallel group, therapeutic equivalence study with clinical endpoint.

Conditions

• Primary Open Angle Glaucoma
• Ocular Hypertension

Interventions

Type	Name	Description
DRUG	Brinzolamide ophthalmic suspension	dose: one drop of study medication; frequency: three times a day; route of administration: Topical ocular administration; duration of therapy: 6 weeks
DRUG	Azopt®	dose: one drop of study medication; frequency: three times a day; route of administration: Topical ocular administration; duration of therapy: 6 weeks

Timeline

• Start date: 2021-12-20
• Primary completion: 2022-12-29
• Completion: 2023-01-06
• First posted: 2021-08-26
• Last updated: 2024-01-18
• Results posted: 2024-01-18

Locations

40 sites across 2 countries: India, Russia

Regulatory

• FDA-regulated drug study