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

AstraZeneca1 site in 1 country50 target enrollmentDecember 2010

ConditionsRaised Intraocular Pressure

InterventionsAZD4017 Placebo

DrugsAZD4017 Placebo

Overview

Phase: Phase 2
Intervention: AZD4017
Conditions: Raised Intraocular Pressure
Sponsor: AstraZeneca
Enrollment: 50
Locations: 1
Primary Endpoint: Percentage Change in Mean Intra-ocular Pressure Compared With Baseline After 4 Weeks Treatment
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

December 2010

End Date

November 2012

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

1) AZD4017

Europe: 200 mg AZD4017

Intervention: AZD4017

2) Placebo

Europe: placebo

Intervention: Placebo

3) AZD4017

USA: 800 mg AZD4017

Intervention: AZD4017

4) Placebo

USA: placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Percentage Change in Mean Intra-ocular Pressure Compared With Baseline After 4 Weeks Treatment

Time Frame: Baseline to 4 weeks

Secondary Outcomes

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)