Ocular HypertensionPhase 3NCT03235232
BREMEN Eye Drops Versus Combigan for Open-angle Glaucoma or Intraocular Hypertension
A Phase 3 study testing BREMEN eye drops and Combigan® in people with Ocular Hypertension and Primary Open-angle Glaucoma, run by EMS at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ocular Hypertension, Primary Open-angle Glaucoma
- What is being tested?
- BREMEN eye drops and Combigan®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 406 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Feb 2021to 31 Oct 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Ocular Hypertension, Primary Open-angle Glaucoma
- Being tested
- BREMEN eye drops, Combigan®
- Medical subject headings
- Ocular Hypertension, Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BREMEN eye dropsDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| BREMEN eye drops | Experimental | 1 drop in affected eye(s), each 12 hours for 8 weeks. Receives: Drug: BREMEN eye drops |
| Combigan® | Active comparator | 1 drop of Combigan® in affected eye(s), each 12 hours for 8 weeks. Receives: Drug: Combigan® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy based in the reduction of intraocular pressure in patients with open-angle glaucoma or hypertension ocular.
Measured: 8 weeks
Secondary outcomes (1)
Safety will be evaluated through the adverse events occurrences
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2017
- Study start1 Feb 2021
- Primary completion31 Jul 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 406 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03235232
- Sponsor's protocol ID
- EMS0117
- Status last verified
- Feb 2024
- First submitted
- 27 Jul 2017
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03235232
- Acronym / sponsor ID
- EMS0117
- Conditions
- Ocular Hypertension, Primary Open-angle Glaucoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 406 participants (actual)
- Lead sponsor
- EMSIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 1 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BREMEN eye drops | Experimental | Drug: BREMEN eye drops1 drop in affected eye(s), each 12 hours for 8 weeks. |
| Combigan® | Active comparator | Drug: Combigan®1 drop of Combigan® in affected eye(s), each 12 hours for 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BREMEN eye drops1 drop in the affected eye(s), twice a day (approximately each 12 hours) for 8 weeks. | Drug | BREMEN eye drops |
| Combigan®1 drop of Combigan® in the affected eye(s), twice a day (approximately each 12 hours) for 8 weeks. | Drug | Combigan® |
Primary outcome
Efficacy based in the reduction of intraocular pressure in patients with open-angle glaucoma or hypertension ocular.
Time frame: 8 weeks
1 secondary outcome
Safety will be evaluated through the adverse events occurrences
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BREMEN eye drops and Combigan® in people with Ocular Hypertension and Primary Open-angle Glaucoma, run by EMS at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy based in the reduction of intraocular pressure in patients with open-angle glaucoma or hypertension ocular. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.