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

Completed · Phase 2 · Has a placebo group

Conditions studied: Raised Intraocular Pressure

In brief

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).

Key facts

Study ID

NCT01173471

Run by

AstraZeneca

People needed

50

Starts

2010-12-01

Expected to finish

2012-11-01

Last updated by the study team

2014-02-14

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Research Site — Newport Beach, California, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Morrow, Georgia, United States
• Research Site — Overland Park, Kansas, United States
• Research Site — Charlotte, North Carolina, United States
• Research Site — Durham, North Carolina, United States
• Research Site — Memphis, Tennessee, United States
• Research Site — Lund, Sweden
• Research Site — Mölndal, Sweden
• Research Site — Stockholm, Sweden
• Research Site — Nottingham, United Kingdom

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.