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

Sucampo

Status and phase: Completed; Phase 2

Conditions: Dry Age-related Macular Degeneration

Treatments: Drug: unoprostone isopropyl

Study type: Interventional

Funder types: Industry

Identifiers

NCT01379560

SPA/UIOS-AMD-1021

Details and patient eligibility

About

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).

Enrollment: 33 patients

Sex: All

Ages: 50+ years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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33 participants in 2 patient groups

unoprostone isopropyl (2 drop)

Experimental group

Treatment:

Drug: unoprostone isopropyl

Drug: unoprostone isopropyl

unoprostone isopropyl (3 drop)

Experimental group

Treatment:

Drug: unoprostone isopropyl

Drug: unoprostone isopropyl