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

Phase 2

Completed

• Conditions: Raised Intraocular Pressure
• Interventions: Drug: Placebo; Drug: AZD4017

• Registration Number: NCT01173471
• Lead Sponsor: AstraZeneca

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-07-29
• Study First Submitted QC: 2010-07-29
• Study First Posted: 2010-08-02
• Study Start: 2010-12
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Results First Submitted: 2013-08-02
• Results First Submitted QC: 2013-08-02
• Results First Posted: 2013-10-14
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-20
• Last Update Posted: 2014-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4) Placebo	Placebo	USA: placebo
1) AZD4017	AZD4017	Europe: 200 mg AZD4017
3) AZD4017	AZD4017	USA: 800 mg AZD4017
2) Placebo	Placebo	Europe: placebo

Primary Outcome Measures

Name	Time	Method
Percentage Change in Mean Intra-ocular Pressure Compared With Baseline After 4 Weeks Treatment	Baseline to 4 weeks

Secondary Outcome Measures

Name	Time	Method
Change in Mean Intra-ocular Pressure Compared With Baseline After 4 Weeks Treatment	Baseline to 4 weeks
Clinically Relevant Change in Intra-ocular Pressure After 4 Weeks of Treatment	Baseline to 4 weeks

Trial Locations

Locations (1)

Research Site; 🇬🇧 Nottingham, United Kingdom