Clinical trial NCT01173471: A Phase IIa Study to Assess the Tolerability, Safety, and Efficacy of AZD4017 for Raised Intra-ocular Pressure
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Raised Intraocular Pressure
Keywords: Raised intraocular pressure
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-08-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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).


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

Primary outcomes:
measure: Percentage Change in Mean Intra-ocular Pressure Compared With Baseline After 4 Weeks Treatment
timeFrame: Baseline to 4 weeks
Secondary outcomes:
measure: Clinically Relevant Change in Intra-ocular Pressure After 4 Weeks of Treatment
timeFrame: Baseline to 4 weeks
measure: Change in Mean Intra-ocular Pressure Compared With Baseline After 4 Weeks Treatment
timeFrame: Baseline to 4 weeks
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Research Site
state: California
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Morrow
country: United States
facility: Research Site
state: Georgia
city: Overland Park
country: United States
facility: Research Site
state: Kansas
city: Charlotte
country: United States
facility: Research Site
state: North Carolina
city: Durham
country: United States
facility: Research Site
state: North Carolina
city: Memphis
country: United States
facility: Research Site
state: Tennessee
city: Lund
country: Sweden
facility: Research Site
city: Molndal
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Nottingham
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca R&D
name: Heather Bryson, PhD
role: STUDY_DIRECTOR
affiliation: AstraZeneca R&D
name: Tony Ho, MD
role: STUDY_DIRECTOR
References: