Dry Age-related Macular Degeneration
Conditions
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).
Interventions
DRUGunoprostone isopropyl
1. unoprostone isopropyl (2 drops) 2. placebo (2 drops)
Sponsors
Sucampo Pharmaceuticals, Inc.
Sucampo Pharma Americas, LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in choroidal blood flow | In total 6 hours |
Countries
Austria
Outcome results
None listed