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

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Raised Intraocular Pressure

Treatments: Drug: Placebo; Drug: AZD4017

Study type: Interventional

Funder types: Industry

Identifiers

NCT01173471

D4250C00001

2010-020932-20 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 50 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 4 patient groups, including a placebo group

1) AZD4017

Experimental group

Description:

Europe: 200 mg AZD4017

Treatment:

Drug: AZD4017

Drug: AZD4017

2) Placebo

Placebo Comparator group

Description:

Europe: placebo

Treatment:

Drug: Placebo

Drug: Placebo

3) AZD4017

Experimental group

Description:

USA: 800 mg AZD4017

Treatment:

Drug: AZD4017

Drug: AZD4017

4) Placebo

Placebo Comparator group

Description:

USA: placebo

Treatment:

Drug: Placebo

Drug: Placebo