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

• Sponsor: Sucampo Pharma Americas, LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01379560
• Collaborator: Sucampo Pharmaceuticals, Inc. (Industry)
• Enrollment: 33
• Location: 1
• Arms: 2
• Duration (Months): 7
• Patients Per Site Per Month: 4.7

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Dry Age-related Macular Degeneration	Drug: unoprostone isopropyl; Drug: unoprostone isopropyl	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 33 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Study Start Date: May 1, 2011
• Actual Primary Completion Date: Dec 1, 2011
• Actual Study Completion Date: Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: unoprostone isopropyl (2 drop)	Drug: unoprostone isopropyl; unoprostone isopropyl (2 drops) placebo (2 drops)
Experimental: unoprostone isopropyl (3 drop)	Drug: unoprostone isopropyl; unoprostone isopropyl (3 drops) placebo (3 drops)

Outcome Measures

Primary Outcome Measures

1. Change in choroidal blood flow [In total 6 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of Vienna	Vienna		Austria

Sponsors and Collaborators

• Sucampo Pharma Americas, LLC
• Sucampo Pharmaceuticals, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sucampo Pharma Americas, LLC
• ClinicalTrials.gov Identifier: NCT01379560
• Other Study ID Numbers: SPA/UIOS-AMD-1021
• First Posted: Jun 23, 2011
• Last Update Posted: Dec 10, 2019
• Last Verified: Mar 1, 2013

• Additional relevant MeSH terms: Macular Degeneration; Isopropyl unoprostone; Dinoprost

Study Results

No Results Posted as of Dec 10, 2019