BREMEN Eye Drops Versus Combigan for Open-angle Glaucoma or Intraocular Hypertension
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|ClinicalTrials.gov Identifier: NCT03235232|
Recruitment Status : Not yet recruiting
First Posted : August 1, 2017
Last Update Posted : October 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Ocular Hypertension Primary Open-angle Glaucoma||Drug: BREMEN eye drops Drug: Combigan®||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||384 participants|
|Intervention Model:||Parallel Assignment|
|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|
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.
1 drop of Combigan® in the affected eye(s), twice a day (approximately each 12 hours) for 8 weeks.
- Efficacy based in the reduction of intraocular pressure in patients with open-angle glaucoma or hypertension ocular. [ Time Frame: 8 weeks ]
- Safety will be evaluated through the adverse events occurrences [ Time Frame: 8 weeks ]
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
|Contact: Roberto B. Amazonas, MDemail@example.com|