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

Phase 2

Completed

• Conditions: Dry Age-related Macular Degeneration
• Interventions: Drug: unoprostone isopropyl

• Registration Number: NCT01379560
• Lead Sponsor: Sucampo Pharma Americas, LLC

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-06-21
• Study First Submitted QC: 2011-06-21
• Study First Posted: 2011-06-23
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2013-03
• Last Update Submitted: 2019-12-06
• Last Update Posted: 2019-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
unoprostone isopropyl (3 drop)	unoprostone isopropyl	-
unoprostone isopropyl (2 drop)	unoprostone isopropyl	-

Primary Outcome Measures

Name	Time	Method
Change in choroidal blood flow	In total 6 hours

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria