Raised Intra-Ocular Pressure or primary open angle glaucoma (POAG) on anti-glaucoma monotherapy that has been stable in dose for at least 30 days prior to screening. MedDRA version: 14.1 Level: LLT Classification code 10036719 Term: Primary open angle glaucoma System Organ Class: 10015919 - Eye disorders MedDRA version: 14.1 Level: LLT Classification code 10022809 Term: Intraocular pressure raised System Organ Class: 10022891 - Investigations
Conditions
Interventions
Product Name: AZD4017
Product Code: AZD4017
Pharmaceutical Form: Tablet
CAS Number: 1024033-43-9
Current Sponsor code: AZD4017
Concentration unit: mg milligram(s)
Concentration type: equal
Concentrati
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of informed consent prior to any study specific procedures. 2. Non-diabetic males and females aged 18 to 80 years, inclusive. 3. Must have a diagnosis of intra-ocular hypertension (raised IOP), or primary open angle glaucoma (POAG), with IOP >20 mmHg and =36 mmHg in the study eye, and is currently prescribed a stable dose of a single anti-glaucoma medication that began at least 30 days prior to the screening visit; OR Must have a diagnosis of intra-ocular hypertension (raised IOP), defined as an IOP =22 mmHg and =36 mmHg in the study eye while not on anti-glaucoma medication. 4. Must have a best corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity score of +0.6 logarithm of the minimum angle of resolution (logMAR [Snellen equivalent of 20/80]) or better in each eye. 5. Must have a =65 years) yes F.1.3.1 Number of subjects for this age range 48
Exclusion criteria
Exclusion criteria: Ocular Exclusion Criteria: - Have uncontrolled intra-ocular hypertension (>36 mmHg). - Have experienced a significant visual field loss or showed evidence of progressive visual field loss within the last year (as defined by >1 dB/yr average loss or vision threatening new defect). Patients with severe central field loss in either eye is defined as a sensitivity =10 dB in at least 2 of the 4 visual field test points closest to the point of fixation. - Have narrow anterior chamber angles in either eye judged potentially occludable if pupillary dilatation were to occur, evidence or history of acute or chronic angle closure, or is at risk for angle closure as evidenced by anterior chamber angle less than grade 2 according to Schaffer classification, as measured by gonioscopy General Exclusion Criteria: - Women of child-bearing potential (WOCBP). - Have uncontrolled systemic hypertension (BP >150/90) - Are receiving systemic (including vaginal/rectal) or inhaled steroid treatment at the time of the screening visit (Visit 2). - Have any screening laboratory abnormality that, in the investigator’s judgement, is considered to be clinically significant. - History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results of the subject’s ability to participate in the study. - Had a change in dose or initiation of systemic therapies (including herbal medications, vitamins, and nutrient supplements [eg, fish oil, and zinc]) that can substantially affect IOP or the study outcome, such as (but not limited to) alpha adrenergic agents, beta-adrenergic blockers, calcium channel blockers, carbonic anhydrase inhibitors, angiotensin-converting enzyme inhibitors or other antihypertensive medications within 30 days prior to the screening visit (Visit 2), or anticipates a change in such therapy during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Final visit assessment;Secondary Objective: • To compare the safety and tolerability of systemically administered AZD4017 with placebo, by evaluation of safety variables. • To investigate the pharmacokinetics (PK) and pharmacodynamics (PD) of AZD4017;Primary end point(s): Percentage decrease from baseline in IOP at endpoint;Main Objective: The primary objective of this study is to evaluate the efficacy of systemically administered AZD4017, compared with placebo, over a 28-day period in patients with raised intra-ocular pressure (IOP) not on anti-glaucoma medication or patients with raised IOP or primary open angle glaucoma (POAG) on anti-glaucoma monotherapy that has been stable in dose for at least 30 days prior to screening. The primary efficacy variable will be the percentage decrease in IOP compared with baseline after 28 days of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1 - Number of patients experiencing a clinically relevant decrease in IOP 2 - Change from baseline to final visit in eye exams, IOP measurements, corneal thickness, clinical laboratory test results, and vital signs 3 - Incidence of AEs, DAEs, SAEs;Timepoint(s) of evaluation of this end point: 1 - Day 28 2 - Throughout study participation 3 - Throughout study participation | — |
Countries
Sweden, United Kingdom, United States
Contacts
Public ContactInformation Center
AstraZeneca AB
Outcome results
None listed