treatment of piromelatine in patients with ocular hypertension or primary open angle glaucoma.

Phase 1

• Conditions: ocular hypertensionprimary open angle glaucoma; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2016-002281-31-ES
• Lead Sponsor: eurim Pharmaceuticals (1991) Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-15
• Last Update Posted: 5 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

1. Aged between 40 and 80 years, of either sex.
2. Clinical diagnosis of either POAG or OHT in both eyes
3. Morning IOP (09:00 am ±1h ) of 22-30 mm Hg (inclusive).
4. POAG patients that DO NOT receive any IOP lowering therapy will be allowed in the study. OHT patients that received IOP lowering medication for a brief period of time and are free from this kind of medication in the 6 months prior to study start will be allowed in the study.
5. Women of childbearing potential use a reliable method of contraception during the entire study duration and for at least 3 months after study drug intake.
6. Male patients and their female spouse/partners who are of childbearing potential must agree to use highly effective methods of contraception, consisting of two forms of birth control (at least one of which must be a barrier method) starting at Screening, throughout the study and for 90 days post-last dose, OR be surgically sterile.
7. Willing and able to attend all study-related visits and be housed overnight at clinical site for the study assessments.
8. Must sign an Informed Consent form.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 47

Exclusion Criteria

Major Exclusion Criteria:
•A patient with OHT or POAG currently on treatment
•A patient with POAG previously treated (regardless of the date treatment was discontinued), or a patient with OHT treated less than 6 months prior to study start.
•Any other glaucoma type (including but not limited to Angle Closure Glaucoma, Secondary Glaucoma, Childhood Glaucoma), and specifically other secondary open angle glaucoma including PSX and Pigmentary glaucoma.
•Very advanced visual field loss in either eye (see Appendix 1).
•patients with any central defects within 5º of fixation or with a central defect within 10º of fixation defined as two or more points with a sensitivity < 20 Db
•Chronic, recurrent or severe inflammatory eye disease.
•Ocular trauma or ocular surgery within the past 6 months.
•Ocular infection or ocular inflammation within the past 3 months.
•Clinically significant or progressive retinal disease.
•Other ocular pathology, that may in the opinion of the investigator preclude the administration of study medication.
•Any other conditions including severe illness which would make the patient, in the opinion of the Investigator, unsuitable for the study.
•Pregnant, intend to become pregnant, breastfeeding.
•Participation in other clinical research within the last 3 months

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified