Prospective, controlled, randomized, investigator-masked, multicenter, phase III trial In this trial, data to demonstrate the efficacy and safety of Brimonidine UD is generated. Subjects either use Brimonidine UD or a control drug. The drugs are assigned randomly. The investigators generating the data are not aware of which drug a subject they are treating received. Investigations are carried out at multiple trial sites (doctor’s offices or hospitals).

Prospective, controlled, randomized, investigator-masked, mul-ticenter, phase III trial to demonstrate the efficacy and safety of Brimonidine UD

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-001489-24-DE

Enrollment

Unknown

Registered

2015-07-29

Start date

2015-11-19

Completion date

Unknown

Last updated

2016-12-12

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

Conditions

open angle glaucoma, elevated intraocular pressure

Interventions

Product Name: Brimonidine UD Pharmaceutical Form: Eye drops, solution in single-dose container INN or Proposed INN: BRIMONIDINTARTRAT CAS Number: 18109-81-4 Concentration unit: mg/ml milligram(s)/mill

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male subjects and female subjects who cannot become pregnant and female subjects of child bearing potential who use an effective contraceptive method. 2. Subject is at least 18 years old. 3. Subject suffers from open angle glaucoma or from ocular hypertension. 4. The condition named in 3. has not been treated pharmacologically before. 5. IOP = 22 mm Hg and = 30 mm Hg 6. Subjects who have been informed about the clinical trial and have signed the informed consent form. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: 1. Eye diseases (except for the ones named in inclusion crite-rion 3) which require treatment. 2. IOP > 30 mm Hg 3. Ocular irritations (e. g. edema, redness) at screening. 4. Ocular inflammation or present effects of previous eye dis-eases which could influence the results of IOP measure-ments. 5. Other glaucoma or ocular hypertension treatment during the trial. 6. Eye surgery 3 month or less prior to screening. 7. Concomitant therapy with monoamine oxidase (MAO) inhibitors or with antidepressants which affect noradrenergic transmission (e.g. tricyclic antidepressants and mianserin). 8. Severe or unstable and uncontrolled cardiovascular conditions 9. Severe systemic concomitant diseases 10. Liver or kidney diseases. 11. Scheduled major surgeries. 12. Enrolment in another clinical trial within the last 4 weeks or during enrolment in this trial. 13. Known hypersensitivity to the active ingredient or any excipient of the IMPs. 14. Women: pregnancy or lactation. 15. Previous or current alcohol or drug abuse. 16. Mental or emotional instability that might jeopardize the validity of the informed consent or the compliance with the trial procedures. 17. Unreliability or lack of cooperation. 18. Other reasons why, in the opinion of the investigator, the subjects should not participate in the trial.

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective of this trial is to demonstrate the efficacy and safety of Brimonidine UD in the reduction of elevated intraocular pressure that can be treated by monotherapy with eye drops containing 1.3 mg/ml brimonidine as the active ingredient.;Secondary Objective: Not applicable;Primary end point(s): Reduction of intraocular pressure;Timepoint(s) of evaluation of this end point: Days 1, 15, and 21	—

Measure

Time frame

Main Objective: The objective of this trial is to demonstrate the efficacy and safety of Brimonidine UD in the reduction of elevated intraocular pressure that can be treated by monotherapy with eye drops containing 1.3 mg/ml brimonidine as the active ingredient.;Secondary Objective: Not applicable;Primary end point(s): Reduction of intraocular pressure;Timepoint(s) of evaluation of this end point: Days 1, 15, and 21

—

Secondary

Measure	Time frame
Secondary end point(s): Safety: ocular irriation; adverse events, overall safety assessment by subject, overall safety assessment by investigator;Timepoint(s) of evaluation of this end point: Days 1, 15, and 21	—

Countries

Germany

Contacts

Public ContactDr. Werdier

SAM GmbH

werdier@sam-germany.de00492418882103

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026