Latanoprost for the Treatment of Menière's Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

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.

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Detailed Description

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Conditions

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Menière's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group 1

One intratympanic injection of latanoprost (Day1)

Group Type EXPERIMENTAL

Latanoprost

Intervention Type DRUG

Group 2

One intratympanic injection of placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Group 3

Three intratympanic injections of latanoprost (Day 1, 2 and 3)

Group Type EXPERIMENTAL

Latanoprost

Intervention Type DRUG

Group 4

Three intratympanic injections of placebo (Day 1, 2 and 3)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Interventions

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Latanoprost

Intervention Type DRUG

Placebo

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No