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

NCT ID: NCT01379560

Last Updated: 2019-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2011-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Dry Age-related Macular Degeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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unoprostone isopropyl (2 drop)

Group Type EXPERIMENTAL

unoprostone isopropyl

Intervention Type DRUG

1. unoprostone isopropyl (2 drops)
2. placebo (2 drops)

unoprostone isopropyl (3 drop)

Group Type EXPERIMENTAL

unoprostone isopropyl

Intervention Type DRUG

1. unoprostone isopropyl (3 drops)
2. placebo (3 drops)

Interventions

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unoprostone isopropyl

1. unoprostone isopropyl (2 drops)
2. placebo (2 drops)

Intervention Type DRUG

unoprostone isopropyl

1. unoprostone isopropyl (3 drops)
2. placebo (3 drops)

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sucampo Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role collaborator

Sucampo Pharma Americas, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Medical University of Vienna

Vienna, , Austria

Site Status

Countries

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Austria

Other Identifiers

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SPA/UIOS-AMD-1021

Identifier Type: -

Identifier Source: org_study_id