NCT03235232

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
406

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 2021

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 1, 2017

Completed
3.5 years until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

2.5 years

First QC Date

July 27, 2017

Last Update Submit

February 15, 2024

Conditions

Ocular HypertensionPrimary Open-angle Glaucoma

Outcome Measures

Primary Outcomes (1)

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

    8 weeks

Secondary Outcomes (1)

  • Safety will be evaluated through the adverse events occurrences

    8 weeks

Study Arms (2)

BREMEN eye drops

EXPERIMENTAL

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

Drug: BREMEN eye drops

Combigan®

ACTIVE COMPARATOR

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

Drug: Combigan®

Interventions

BREMEN eye dropsDRUG

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

BREMEN eye drops
Combigan®DRUG

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

Combigan®

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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;
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Allegisa

Campinas, São Paulo, 13.084-791, Brazil

Location

MeSH Terms

Conditions

Ocular HypertensionGlaucoma, Open-Angle

Interventions

Brimonidine Tartrate, Timolol Maleate Drug Combination

Condition Hierarchy (Ancestors)

Eye DiseasesGlaucoma

Intervention Hierarchy (Ancestors)

TimololPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesThiadiazolesThiazolesSulfur CompoundsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBrimonidine TartrateQuinoxalinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingDrug CombinationsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2017

First Posted

August 1, 2017

Study Start

February 1, 2021

Primary Completion

July 31, 2023

Study Completion

October 31, 2023

Last Updated

February 20, 2024

Record last verified: 2024-02

Locations

BR(1)