Menière's Disease
Conditions
Keywords
Menière's disease, Vertigo, Hearing loss, Tinnitus
Brief summary
The purpose of the study is to evaluate the dose regimen, efficacy and safety of latanoprost for the treatment of Menière's disease.
Interventions
OTHERPlacebo
DRUGLatanoprost
Sponsors
Synphora AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in speech discrimination score in noise from Baseline | 2 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change in proportion of days with vertigo attacks from run-in period | 3 months |
| Comparison of number of drop attacks in each treatment arm | 3 months |
| Evaluation of adverse events and vital signs as measure of safety and tolerability | 3 months |
| Change in hearing (Likert scale), tinnitus (Likert scale) and vertigo (Likert scale) from run-in period | 3 months |
| Change in pure tone audiometry from Baseline | 3 months |
| Change in THI-25 (Tinnitus Handicap Inventory) score from Baseline | 3 months |
| Change in speech discrimination score in noise from Baseline | 3 months |
Countries
Sweden
Outcome results
None listed