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

Sucampo Pharma Americas, LLC1 site in 1 country33 target enrollmentMay 2011

ConditionsDry Age-related Macular Degeneration

Interventionsunoprostone isopropyl

Drugsunoprostone isopropyl

Overview

Phase: Phase 2
Intervention: unoprostone isopropyl
Conditions: Dry Age-related Macular Degeneration
Sponsor: Sucampo Pharma Americas, LLC
Enrollment: 33
Locations: 1
Primary Endpoint: Change in choroidal blood flow
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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).

Registry

clinicaltrials.gov

Start Date

May 2011

End Date

December 2011

Last Updated

6 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Sucampo Pharma Americas, LLC

Responsible Party

Sponsor

Eligibility Criteria

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)