CClinicalTrials.gg
CompletedNCT03235232Updated Feb 20, 2024

BREMEN Eye Drops Versus Combigan for Open-angle Glaucoma or Intraocular Hypertension

A Phase 3 interventional study of BREMEN eye drops and Combigan® in Ocular Hypertension and Primary Open-angle Glaucoma, sponsored by EMS. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-20.

Sponsored by EMS · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
406
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to evaluate the clinical efficacy of the BREMEN eye drops in the treatment of primary open-angle glaucoma or intraocular hypertension.

02

Conditions studied

  • Ocular Hypertension
  • Primary Open-angle Glaucoma
03

In context

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's enrollment of 406 is above the median of 65 across 1,272 interventional studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

EMS is the lead sponsor of 84 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Signed Consent;
  • Participants with diagnosis of open-angle glaucoma or hypertension ocular, who needs treatment with drugs association to control the intraocular pressure;
  • Participants who have 20/80 visual acuity or more, in both eyes;

Exclusion criteria

Exclusion Criteria:

  • Participants with any clinical significant disease that, after evaluation of the investigator, can´t participate in the study;
  • Participants with active eye disease, which in the investigator opinion may interfere in the results of this clinical trial;
  • Participants presenting previous diagnosis of non-operated cataract, high myopia, high astigmatism, pseudoexfoliation and corneal deformities;
  • Participants who had significant visual loss in the last year;
  • Treatment-naive participants for open-angle glaucoma or ocular hypertension;
  • Participants nonresponders to previous triple combination drug therapy, used in concomitance;
  • Participants with previous ocular or intraocular surgery within six months prior to enrollment in the clinical trial;
  • Participants with history of hypersensitivity to any formula compounds;
  • Participants presenting contraindications to use of beta-adrenergic antagonists;
  • Participants diagnosed with uncontrolled cardiovascular disease;
  • Participants with severe renal insufficiency or hyperchloremic acidosis;
  • Participants in therapy with monoamine oxidase inhibitors (MAOIs);
  • Participants who were in use of drugs that can interfere in the evaluation;
  • Pregnancy or risk of pregnancy and lactating patients;
  • Alcoholism or illicit drug abuse in the last two years;
  • Participation in clinical trial in the year prior to this study.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
406 participants (actual)

Study arms

  • Experimental
    BREMEN eye drops

    1 drop in affected eye(s), each 12 hours for 8 weeks.

    Drug: BREMEN eye drops

  • Active comparator
    Combigan®

    1 drop of Combigan® in affected eye(s), each 12 hours for 8 weeks.

    Drug: Combigan®

Interventions

  • DrugBREMEN eye drops

    1 drop in the affected eye(s), twice a day (approximately each 12 hours) for 8 weeks.

  • DrugCombigan®

    1 drop of Combigan® in the affected eye(s), twice a day (approximately each 12 hours) for 8 weeks.

06

What researchers measure

Primary outcomes

  1. Efficacy based in the reduction of intraocular pressure in patients with open-angle glaucoma or hypertension ocular.

    Time frame: 8 weeks

Secondary outcomes

  1. Safety will be evaluated through the adverse events occurrences

    Time frame: 8 weeks

07

Study locations

1 site
  • Allegisa
    Campinas, São Paulo 13.084-791, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03235232
Lead sponsor
EMS
Responsible party
Sponsor
First posted
Aug 1, 2017
Start date
Feb 1, 2021
Primary completion
Jul 31, 2023
Completion
Oct 31, 2023
Last update
Feb 20, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion