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

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2011

Interventions

  • Drug: unoprostone isopropyl
    • unoprostone isopropyl (2 drops) placebo (2 drops)
  • Drug: unoprostone isopropyl
    • unoprostone isopropyl (3 drops) placebo (3 drops)

Arms, Groups and Cohorts

  • Experimental: unoprostone isopropyl (2 drop)
  • Experimental: unoprostone isopropyl (3 drop)

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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 Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sucampo Pharma Americas, LLC
  • Collaborator
    • Sucampo Pharmaceuticals, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor

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