Latanoprost for the Treatment of Menière's Disease

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Synphora AB
• Treatments: Latanoprost

Criteria

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