Title
Latanoprost for the Treatment of Menière's Disease
A Randomized, Double Blind, Placebo-controlled, Parallel Group Study to Determine the Efficacy, the Duration of Action, and Safety of Latanoprost in Patients With Menière's Disease
Phase
Phase 2Lead Sponsor
Synphora ABStudy Type
InterventionalStatus
Unknown statusIndication/Condition
Menière's DiseaseIntervention/Treatment
latanoprost ...Study Participants
100The purpose of the study is to evaluate the dose regimen, efficacy and safety of latanoprost for the treatment of Menière's disease.
Three intratympanic injections of latanoprost (Day 1, 2 and 3)
Inclusion Criteria: At least 18 years of age Definitive unilateral Menière's disease (AAO-HNS 1995) Disease stage II - III: PTA4 (Pure Tone Average) (0.5, 1.0, 2.0 and 3.0kHz) between 25dB and 70dB Speech discrimination score in silence: No better than 85% At least three vertigo attacks (lasting ≥ 20 minutes) during the last three months prior to inclusion Tinnitus during the last three months prior to inclusion Signed written informed consent Exclusion Criteria: Medical or psychiatric conditions which could jeopardize or would compromise the subject's ability to participate in the trial or decrease the likelihood of obtaining satisfactory data to achieve the objective of the trial, dementia, alcohol or substance abuse. Bilateral Menière's disease Chronic otitis media on the ear affected by Menière's disease Subjects not fluent in Swedish language Bronchial asthma Previous intratympanic injection of gentamicin or surgical therapy Previous intratympanic steroid therapy less than six months prior to inclusion Known hypersensitivity to local anesthetics Pregnant women Nursing mothers
