Last updated: February 15, 2024
Sponsor: EMS
Overall Status: Completed
Phase
3
Condition
Ocular Hypertension
Williams Syndrome
Glaucoma
Treatment
Combigan®
BREMEN eye drops
Clinical Study ID
NCT03235232
EMS0117
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Signed Consent;
- Participants with diagnosis of open-angle glaucoma or hypertension ocular, who needstreatment with drugs association to control the intraocular pressure;
- Participants who have 20/80 visual acuity or more, in both eyes;
Exclusion
Exclusion Criteria:
- Participants with any clinical significant disease that, after evaluation of theinvestigator, can´t participate in the study;
- Participants with active eye disease, which in the investigator opinion may interferein the results of this clinical trial;
- Participants presenting previous diagnosis of non-operated cataract, high myopia, highastigmatism, 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 inconcomitance;
- Participants with previous ocular or intraocular surgery within six months prior toenrollment 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.
Study Design
Total Participants: 406
Treatment Group(s): 2
Primary Treatment: Combigan®
Phase: 3
Study Start date:
February 01, 2021
Estimated Completion Date:
October 31, 2023
Connect with a study center
Allegisa
Campinas, São Paulo 13.084-791
BrazilSite Not Available
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