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

December 6, 2019 updated by: Sucampo Pharma Americas, LLC
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria
        • Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

48 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: unoprostone isopropyl (2 drop)
Drug: unoprostone isopropyl
  1. unoprostone isopropyl (2 drops)
  2. placebo (2 drops)
Drug: unoprostone isopropyl
  1. unoprostone isopropyl (3 drops)
  2. placebo (3 drops)
Experimental: unoprostone isopropyl (3 drop)
Drug: unoprostone isopropyl
  1. unoprostone isopropyl (2 drops)
  2. placebo (2 drops)
Drug: unoprostone isopropyl
  1. unoprostone isopropyl (3 drops)
  2. placebo (3 drops)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in choroidal blood flow
Time Frame: In total 6 hours
In total 6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sucampo Pharma Americas, LLC

Collaborators

Sucampo Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

June 21, 2011

First Submitted That Met QC Criteria

June 21, 2011

First Posted (Estimate)

June 23, 2011

Study Record Updates

Last Update Posted (Actual)

December 10, 2019

Last Update Submitted That Met QC Criteria

December 6, 2019

Last Verified

March 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPA/UIOS-AMD-1021

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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