A Study to Evaluate the Ocular Blood Flow Effects of Unoprostone Isopropyl in Adults With Dry Age-related Macular Degeneration

The purpose of this study is to determine the pharmacodynamics of ocular blood flow measurements with multiple drop unoprostone isopropyl administration versus placebo in subjects with dry age-related macular degeneration (AMD).

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Key information

Conditions

Dry Age-related Macular Degeneration

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Medical University of Vienna

Vienna, Austria

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Age ≥ 50 years at screening
Ametropy ≤ 3 diopters
Clear ocular media
Visual acuity in the study eye > 20/40

Exclusion criteria

Presence of any ocular condition in the study eye (other than AMD) that may progress during the course of the study and could affect central vision, or other ocular conditions that may be a confounding factor in this study
Blood donation during the previous 3 weeks
Current smoker or a history of smoking within 5 years of enrollment
Treatment with protocol-specified prohibited concomitant medications
Prior exposure to Rescula (unoprostone isopropyl) and or a known sensitivity to any of the components of the study medication (e.g. benzalkonium chloride)

Treatment and study plan

unoprostone isopropyl

Drug

unoprostone isopropyl (2 drops)
placebo (2 drops)

Primary outcomes

Change in choroidal blood flow

Time frame: In total 6 hours

Sponsors and collaborators

Lead sponsor

Sucampo Pharma Americas, LLC

Industry

Collaborators

Sucampo Pharmaceuticals, Inc.

Registry information

Important dates

Study start: 2011
Primary completion: 2011
Study completion: 2011
First posted: Jun 23, 2011
Registry last updated: Dec 10, 2019

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.

Published trials that share one or more normalized conditions with this study.

Completed