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OpenTrials
Completed

NCT Number: NCT03235232

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

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.

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Key information

Conditions

Ocular Hypertension Eye Diseases Glaucoma Glaucoma, Open-Angle Primary Open-Angle Glaucoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Allegisa

Campinas, São Paulo, 13.084-791, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

BREMEN eye drops

Drug

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

Combigan®

Drug

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

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

Sponsors and collaborators

Lead sponsor

EMS

Industry

Registry information

Official study title

Randomized Clinical Trial to Compare the Efficacy and Safety of BREMEN Eye Drops Versus Combigan in Subjects With Open Angle Glaucoma or Ocular Hypertension

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 1, 2017
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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