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

  • STATUS
    Recruiting
  • End date
    Feb 5, 2023
  • participants needed
    384
  • sponsor
    EMS
Updated on 5 March 2021

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.

Details
Condition EYE DISORDER, Eye Disorders/Infections, Eye Disorders/Infections (Pediatric), Dry Eye Disease, Eye Disease, Ocular Hypertension, Ocular Hypertension, Glaucoma, Glaucoma, Pigmentary glaucoma, Open Angle Glaucoma, Eye Disorders/Infections, Dry Eye Disease, Primary Open Angle Glaucoma, Eye Disorders/Infections (Pediatric), Eye Disease, Open Angle Glaucoma
Treatment BREMEN eye drops, Combigan®
Clinical Study IdentifierNCT03235232
SponsorEMS
Last Modified on5 March 2021

Eligibility

Yes No Not Sure

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, cant 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
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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