The purpose of the study is to evaluate the dose regimen, efficacy and safety of latanoprost for the treatment of Menière's disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
Falu Lasarett
Falun, Sweden
Sahlgrenska Universitetssjukhuset
Gothenburg, Sweden
Blekinge Hospital
Karlskrona, Sweden
Centralsjukhuset i Karlstad
Change in speech discrimination score in noise from Baseline
Time frame: 2 weeks
Change in speech discrimination score in noise from Baseline
Time frame: 3 months
Change in pure tone audiometry from Baseline
Time frame: 3 months
Change in THI-25 (Tinnitus Handicap Inventory) score from Baseline
Time frame: 3 months
Change in hearing (Likert scale), tinnitus (Likert scale) and vertigo (Likert scale) from run-in period
Time frame: 3 months
Change in proportion of days with vertigo attacks from run-in period
Time frame: 3 months
Comparison of number of drop attacks in each treatment arm
Time frame: 3 months
Evaluation of adverse events and vital signs as measure of safety and tolerability
Time frame: 3 months
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Karlstad, Sweden
Centralsjukhuset i Kristianstad
Kristianstad, Sweden
Linköping University Hospital
Linköping, Sweden
Sunderby Sjukhus
Luleå, Sweden
Lund University Hospital
Lund, Sweden
University Hospital Örebro
Örebro, Sweden
Karolinska Universitetssjukhuset
Stockholm, Sweden
...and 2 more locations