Latanoprost for the Treatment of Menière's Disease

Synphora

Status and phase: Unknown; Phase 2

Conditions: Menière's Disease

Treatments: Other: Placebo; Drug: Latanoprost

Study type: Interventional

Funder types: Industry

Identifiers

NCT01973114

M 05 - 2013

Details and patient eligibility

About

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

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 4 patient groups, including a placebo group

Group 1

Experimental group

Description:

One intratympanic injection of latanoprost (Day1)

Treatment:

Drug: Latanoprost

Group 2

Placebo Comparator group

Description:

One intratympanic injection of placebo

Treatment:

Other: Placebo

Group 3

Experimental group

Description:

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

Treatment:

Drug: Latanoprost

Group 4

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo