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Completed

NCT Number: NCT01173471

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

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).

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Key information

Conditions

Raised Intraocular Pressure Eye Diseases Ocular Hypertension

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Lund, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD4017

Drug

tablet, oral, one tablet once daily, 28 days

Placebo

Drug

matching placebo tablet, oral, one tablet once daily, 28 days

Primary outcomes

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

    Time frame: Baseline to 4 weeks

Secondary outcomes

  1. Clinically Relevant Change in Intra-ocular Pressure After 4 Weeks of Treatment

    Time frame: Baseline to 4 weeks

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

    Time frame: Baseline to 4 weeks

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Aug 2, 2010
Registry last updated
Feb 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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