Latanoprost for the Treatment of Menière's Disease

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the dose regimen, efficacy and safety of latanoprost for the treatment of Menière's disease.

Official Title
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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

Conditions
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Menière's Disease

Intervention / Treatment
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* Drug: Latanoprost
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>One intratympanic injection of latanoprost (Day1) | Drug: Latanoprost<br> <br> |
| Placebo Comparator: Group 2<br>One intratympanic injection of placebo | Other: Placebo<br> <br> |
| Experimental: Group 3<br>Three intratympanic injections of latanoprost (Day 1, 2 and 3) | Drug: Latanoprost<br> <br> |
| Placebo Comparator: Group 4<br>Three intratympanic injections of placebo (Day 1, 2 and 3) | Other: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in speech discrimination score in noise from Baseline |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in speech discrimination score in noise from Baseline |  | 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 hearing (Likert scale), tinnitus (Likert scale) and vertigo (Likert scale) from run-in period |  | 3 months | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Menière's disease, Vertigo, Hearing loss, Tinnitus