A Therapeutic Non-Inferiority, Randomized, Observer-blind, Active-comparator, Two-arm, Parallel Group, Multi-center Clinical Trial for Comparing the Efficacy and Tolerability of a Generic Fixed Dose Combination of Brimonidine Tartrate 2 mg/ml + Timolol 5 mg/ml Eye Drops versus Combigan® 2 mg/ml + 5 mg/ml Eye Drops in the Treatment of Intraocular Pressure in Patients with Open Angle Glaucoma or Ocular Hypertension

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-523227-22-00

Enrollment

180

Registered

2026-03-27

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-27

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

Conditions

Ocular Hypertension, Glaucoma

Brief summary

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

Detailed description

Difference between Test and Comparator in mean diurnal IOP change from baseline to week 2 visit after adjusting for baseline measurement (week 0)., Difference between Test and Comparator 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

DRUGBrimonidine-Timolol

DRUGCombigan

DRUG2 mg/ml + 5 mg/ml

DRUGkrople do oczu

DRUGroztwór

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 Comparator 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 Comparator in mean diurnal IOP change from baseline to week 2 visit after adjusting for baseline measurement (week 0)., Difference between Test and Comparator 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.	—

Outcome results

None listed

Source: EU CTIS · Data processed: Mar 28, 2026