Prospective, controlled, randomized, investigator-masked, mul-ticenter, phase III trial to demonstrate the efficacy and safety of Brimonidine UD

Pharma Stulln GmbH0 个研究点开始时间: 2015年7月29日最近更新: 2016年12月12日

试验速览

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•1. Male subjects and female subjects who cannot become pregnant and female subjects of child bearing potential who use an effective contraceptive method.
•2. Subject is at least 18 years old.
•3. Subject suffers from open angle glaucoma or from ocular hypertension.
•4. The condition named in 3. has not been treated pharmacologically before.
•5. IOP = 22 mm Hg and = 30 mm Hg
•6. Subjects who have been informed about the clinical trial and have signed the informed consent form.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 50
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•1. Eye diseases (except for the ones named in inclusion crite-rion 3) which require treatment.
•2. IOP > 30 mm Hg
•3. Ocular irritations (e. g. edema, redness) at screening.
•4. Ocular inflammation or present effects of previous eye dis-eases which could influence the results of IOP measure-ments.
•5. Other glaucoma or ocular hypertension treatment during the trial.
•6. Eye surgery 3 month or less prior to screening.
•7. Concomitant therapy with monoamine oxidase (MAO) inhibitors or with antidepressants which affect noradrenergic transmission (e.g. tricyclic antidepressants and mianserin).
•8. Severe or unstable and uncontrolled cardiovascular conditions
•9. Severe systemic concomitant diseases
•10. Liver or kidney diseases.
•11. Scheduled major surgeries.
•12. Enrolment in another clinical trial within the last 4 weeks or during enrolment in this trial.
•13. Known hypersensitivity to the active ingredient or any excipient of the IMPs.
•14. Women: pregnancy or lactation.
•15. Previous or current alcohol or drug abuse.
•16. Mental or emotional instability that might jeopardize the validity of the informed consent or the compliance with the trial procedures.
•17. Unreliability or lack of cooperation.
•18. Other reasons why, in the opinion of the investigator, the subjects should not participate in the trial.

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