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

Sponsors

Lead Sponsor: Sucampo Pharma Americas, LLC

Collaborator: Sucampo Pharmaceuticals, Inc.

Source Mallinckrodt
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).

Overall Status Completed
Start Date May 2011
Completion Date December 2011
Primary Completion Date December 2011
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in choroidal blood flow In total 6 hours
Enrollment 33
Condition
Intervention

Intervention Type: Drug

Intervention Name: unoprostone isopropyl

Description: unoprostone isopropyl (2 drops) placebo (2 drops)

Arm Group Label: unoprostone isopropyl (2 drop)

Intervention Type: Drug

Intervention Name: unoprostone isopropyl

Description: unoprostone isopropyl (3 drops) placebo (3 drops)

Arm Group Label: unoprostone isopropyl (3 drop)

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)

Gender: All

Minimum Age: 50 Years

Maximum Age: N/A

Healthy Volunteers: No

Location
Facility: Medical University of Vienna
Location Countries

Austria

Verification Date

March 2013

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: unoprostone isopropyl (2 drop)

Type: Experimental

Label: unoprostone isopropyl (3 drop)

Type: Experimental

Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov