A Study to Evaluate the Ocular Blood Flow Effects of Unoprostone Isopropyl in Adults With Dry Age-related Macular Degeneration
1 other identifier
interventional
33
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2011
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 21, 2011
CompletedFirst Posted
Study publicly available on registry
June 23, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedDecember 10, 2019
March 1, 2013
7 months
June 21, 2011
December 6, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Change in choroidal blood flow
In total 6 hours
Study Arms (2)
unoprostone isopropyl (2 drop)
EXPERIMENTALunoprostone isopropyl (3 drop)
EXPERIMENTALInterventions
1. unoprostone isopropyl (2 drops) 2. placebo (2 drops)
Eligibility Criteria
You may qualify if:
- Age ≥ 50 years at screening
- Ametropy ≤ 3 diopters
- Clear ocular media
- Visual acuity in the study eye \> 20/40
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sucampo Pharma Americas, LLClead
- Sucampo Pharmaceuticals, Inc.collaborator
Study Sites (1)
Medical University of Vienna
Vienna, Austria
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2011
First Posted
June 23, 2011
Study Start
May 1, 2011
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
December 10, 2019
Record last verified: 2013-03