Status:
COMPLETED
A Phase IIa Study to Assess the Tolerability, Safety, and Efficacy of AZD4017 for Raised Intra-ocular Pressure
Lead Sponsor:
AstraZeneca
Conditions:
Raised Intraocular Pressure
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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
- 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
- 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
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01173471
Start Date
December 1 2010
End Date
November 1 2012
Last Update
February 14 2014
Active Locations (11)
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1
Research Site
Newport Beach, California, United States
2
Research Site
Atlanta, Georgia, United States
3
Research Site
Morrow, Georgia, United States
4
Research Site
Overland Park, Kansas, United States