A Phase IIa Study to Assess the Tolerability, Safety, and Efficacy of AZD4017 for Raised Intra-ocular Pressure

Study Overview
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Brief Summary
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The purpose 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).

Official Title
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A Double Masked, Placebo Controlled, Randomised, Parallel Group Phase IIa Study to Assess the Tolerability, Safety, and Efficacy of AZD4017 for Raised Intra-Ocular Pressure

Conditions
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Raised Intraocular Pressure

Intervention / Treatment
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* Drug: AZD4017
* Drug: Placebo
* Drug: AZD4017
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Male patients must be willing to use barrier contraception with spermicide, ie, condoms, from the day of first dosing until 3 months after dosing with IP Placebo treatment for duration of the study must not be considered detrimental to the patient 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) Have had severe eye trauma at any time

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1) AZD4017<br>Europe: 200 mg AZD4017 | Drug: AZD4017<br>* tablet, oral, one tablet once daily, 28 days<br>|
| Placebo Comparator: 2) Placebo<br>Europe: placebo | Drug: Placebo<br>* matching placebo tablet, oral, one tablet once daily, 28 days<br>|
| Experimental: 3) AZD4017<br>USA: 800 mg AZD4017 | Drug: AZD4017<br>* tablet, oral 2 tablets twice daily, 28 days<br>|
| Placebo Comparator: 4) Placebo<br>USA: placebo | Drug: Placebo<br>* matching placebo tablets, oral, 2 tablets twice daily, 28 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage Change in Mean Intra-ocular Pressure Compared With Baseline After 4 Weeks Treatment |  | Baseline to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinically Relevant Change in Intra-ocular Pressure After 4 Weeks of Treatment |  | Baseline to 4 weeks | 
| Change in Mean Intra-ocular Pressure Compared With Baseline After 4 Weeks Treatment |  | Baseline to 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Raised intraocular pressure