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

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sucampo Pharma Americas, LLC; Sucampo Pharmaceuticals, Inc.
• Collaborator: Sucampo Pharmaceuticals, Inc.
• Treatments: Dinoprost; Isopropyl unoprostone

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)