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Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Pharma Stulln GmbH
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •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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