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

Last updated: February 15, 2024
Sponsor: EMS
Overall Status: Completed

Phase

3

Condition

Ocular Hypertension

Williams Syndrome

Glaucoma

Treatment

Combigan®

BREMEN eye drops

Clinical Study ID

NCT03235232
EMS0117
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Participants with any clinical significant disease that, after evaluation of theinvestigator, can´t participate in the study;
  • Participants with active eye disease, which in the investigator opinion may interferein the results of this clinical trial;
  • Participants presenting previous diagnosis of non-operated cataract, high myopia, highastigmatism, 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 inconcomitance;
  • Participants with previous ocular or intraocular surgery within six months prior toenrollment 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.

Study Design

Total Participants: 406
Treatment Group(s): 2
Primary Treatment: Combigan®
Phase: 3
Study Start date:
February 01, 2021
Estimated Completion Date:
October 31, 2023

Connect with a study center

  • Allegisa

    Campinas, São Paulo 13.084-791
    Brazil

    Site Not Available

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