A Therapeutic Non-Inferiority, Randomized, Observer-blind, Active-reference, Two-arm, Parallel Group, Multi-center Clinical Trial for Comparing the Efficacy and Tolerability of a Generic Fixed Combination of Brinzolamide 10mg/ml + Timolol 5mg/ml Eye Drops versus Azarga® 10mg/ml + 5mg/ml Eye Drops in the Treatment of Intraocular Pressure in Patients with Open Angle Glaucoma or Ocular Hypertension

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-506494-35-00

Acronym

BECRO/OV/BRINZOTIM

Enrollment

234

Registered

2024-05-20

Start date

2024-07-15

Completion date

2025-05-21

Last updated

2025-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma, Ocular Hypertension

Brief summary

The primary efficacy endpoint will be the difference between Test and Reference products in mean diurnal IOP change from baseline to week 12 visit after adjusting for baseline measurement (week 0)

Detailed description

Difference between Test and Reference products in mean diurnal IOP change from baseline to week 2 visit after adjusting for baseline measurement (week 0), Difference between Test and Reference products in mean diurnal IOP change from baseline to week 6 visit after adjusting for baseline measurement (week 0), Frequency of study drugs’ related adverse events

Interventions

DRUGAZARGA 10 mg/mL + 5 mg/mL eye drops

DRUGsuspension

DRUGBrinzolamide-Timolol

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary efficacy endpoint will be the difference between Test and Reference products in mean diurnal IOP change from baseline to week 12 visit after adjusting for baseline measurement (week 0)	—

Secondary

Measure	Time frame
Difference between Test and Reference products in mean diurnal IOP change from baseline to week 2 visit after adjusting for baseline measurement (week 0), Difference between Test and Reference products in mean diurnal IOP change from baseline to week 6 visit after adjusting for baseline measurement (week 0), Frequency of study drugs’ related adverse events	—

Countries

Greece

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026