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

Primary Purpose

Dry Age-related Macular Degeneration

Status
Completed
Phase
Phase 2
Locations
Austria
Study Type
Interventional
Intervention
unoprostone isopropyl
unoprostone isopropyl
Sponsored by
Sucampo Pharma Americas, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Age-related Macular Degeneration

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Medical University of Vienna

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

unoprostone isopropyl (2 drop)

unoprostone isopropyl (3 drop)

Arm Description

Outcomes

Primary Outcome Measures

Change in choroidal blood flow

Secondary Outcome Measures

Full Information

First Posted
June 21, 2011
Last Updated
December 6, 2019
Sponsor
Sucampo Pharma Americas, LLC
Collaborators
Sucampo Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01379560
Brief Title
A Study to Evaluate the Ocular Blood Flow Effects of Unoprostone Isopropyl in Adults With Dry Age-related Macular Degeneration
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sucampo Pharma Americas, LLC
Collaborators
Sucampo Pharmaceuticals, Inc.

4. Oversight

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Age-related Macular Degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
unoprostone isopropyl (2 drop)
Arm Type
Experimental
Arm Title
unoprostone isopropyl (3 drop)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
unoprostone isopropyl
Intervention Description
unoprostone isopropyl (2 drops) placebo (2 drops)
Intervention Type
Drug
Intervention Name(s)
unoprostone isopropyl
Intervention Description
unoprostone isopropyl (3 drops) placebo (3 drops)
Primary Outcome Measure Information:
Title
Change in choroidal blood flow
Time Frame
In total 6 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
Country
Austria

12. IPD Sharing Statement

Learn more about this trial

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

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