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

Dry Age-related Macular Degeneration Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01379560
• Other study ID #: SPA/UIOS-AMD-1021
• Status: Completed
• Phase: Phase 2
• Start date: May 2011
• Est. completion date: December 2011

Study information

• Verified date: March 2013
• Source: Mallinckrodt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Dry Age-related Macular Degeneration
• Macular Degeneration

Intervention

Drug:
• unoprostone isopropyl
unoprostone isopropyl (2 drops) placebo (2 drops)
• unoprostone isopropyl
unoprostone isopropyl (3 drops) placebo (3 drops)

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (2)

Lead Sponsor	Collaborator
Sucampo Pharma Americas, LLC	Sucampo Pharmaceuticals, Inc.

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in choroidal blood flow		In total 6 hours