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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03235232
Recruitment Status : Not yet recruiting
First Posted : August 1, 2017
Last Update Posted : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
EMS

Brief 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.

Condition or disease Intervention/treatment Phase
Ocular Hypertension Primary Open-angle Glaucoma Drug: BREMEN eye drops Drug: Combigan® Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 384 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official 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
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Experimental: BREMEN eye drops
1 drop in affected eye(s), each 12 hours for 8 weeks.
Drug: BREMEN eye drops
1 drop in the affected eye(s), twice a day (approximately each 12 hours) for 8 weeks.

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




Primary Outcome Measures :
  1. Efficacy based in the reduction of intraocular pressure in patients with open-angle glaucoma or hypertension ocular. [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Safety will be evaluated through the adverse events occurrences [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03235232


Contacts
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Contact: Roberto B. Amazonas, MD +551938879851 pesquisa.clinica@ems.com.br

Sponsors and Collaborators
EMS

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Responsible Party: EMS
ClinicalTrials.gov Identifier: NCT03235232     History of Changes
Other Study ID Numbers: EMS0117
First Posted: August 1, 2017    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Ophthalmic Solutions
Brimonidine Tartrate, Timolol Maleate Drug Combination
Pharmaceutical Solutions
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists