ocular hypertension primary open angle glaucoma
Conditions
Interventions
Product Name: Piromelatine
Pharmaceutical Form: Tablet
INN or Proposed INN: Piromelatine
CAS Number: 946846-83-9
Other descriptive name: Piromelatine is also known by the laboratory code Neu-P11. Neu-
Sponsors
Neurim Pharmaceuticals (1991) Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objective: To evaluate the safety and tolerability of 30 days piromelatine treatment vs placebo in ocular hypertension (OHT) or primary open angle glaucoma (POAG) patients. ;Secondary Objective: Secondary Objectives: 1. To compare the effect of the piromelatine treatment to that of placebo on mean intraocular pressure (IOP) after 30 days of double blind treatment 2. To compare the effect of 30 days piromelatine treatment to that of placebo on night time IOP. 3. To compare the effect of 30 days piromelatine treatment to that of placebo on daytime IOP. 4. To compare the effect of 30 days piromelatine treatment to that of placebo on mean postural (supine-sitting) fluctuations (PFs) of IOP during the day 5. To compare the effect of 30 days piromelatine treatment to that of placebo on mean diurnal variation (DV) of IOP in supine position ;Primary end point(s): The safety parameters will be summarized using descriptive statistics: n, mean, median, standard deviation (SD), standard error of the mean (SEM), minimum, maximum, number of out-of-range values if applicable, ;Timepoint(s) of evaluation of this end point: Screening, Baseline (Visit 2), Visit 3 and Visit 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints: • IOP – Intraocular pressure at supine and sitting position at night time and during the day • PF – The difference of IOP in the supine and sitting position at each time point. • DV – The difference between maximum and minimum IOP during the 24 h period DV for sitting and supine postures Exploratory endpoints • Sleep questionnaire items • Ambulatory blood pressure monitoring (ABPM) ;Timepoint(s) of evaluation of this end point: Baseline (Visit 2), Visit 3 and Visit 4 | — |
Countries
Spain
Contacts
Public ContactClinical Trials Information
QPS Austria
Outcome results
None listed