Intratympanic Latanoprost for Menière’s Disease - A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study

Background: Two previous placebo-controlled cross-over studies in patients with long-standing Meniere have shown positive effects on hearing, tinnitus and vertigo after intratympanic injections of latanoprost, a F2α-prostaglandin analogue commonly used to treat glaucoma, but the low number of patients made firm conclusions difficult.

Objective: To assess the effects on hearing, tinnitus and vertigo of 1 or 3 intratympanic injections of latanoprost in patients with definite Meniere´s disease in a prospective, randomized, double-blind, placebo-controlled, parallel group study.

Methods: 100 patients were recruited at 12 ENT-departments in Sweden. Inclusion criteria were unilateral definite Meniere´s disease of stage II-IV, speech discrimination < 85% and > 2 vertigo attacks during the previous 3 months. Patients were randomized to receive 1 injection of latanoprost 0.005% (n= 27), 1 injection of placebo (n=13), 3 injections of latanoprost 0.005% (n=40) or 3 injections of placebo (n=20) on 3 consecutive days. Before treatment start there was a run-in period of 4-6 weeks (28-42 days)

Primary endpoint was speech discrimination score in noise (SDSN) at day 14 after first injection. Secondary endpoints were total number of vertigo and drop attacks during 3 months, SDSN, pure tone audiometry, Tinnitus Handicap Inventory (THI), subjective assessment of tinnitus, hearing and vertigo by Likert scales at Days 28, 42, 56 and 84.

Results: There were no statistically significant differences between placebo and latanoprost in any of the endpoints. There were, however, trends of an improvement in hearing following 1 intratympanic injection measured both as (1) pure tone audiometry (at all frequencies; 250 - 8 KHz) and (2) SDSN. There was also a trend of an improvement in THI-score following 3 injections.

Conclusion: In perspective of the trends of improvement in both hearing and tinnitus it appears logical to increase the exposure to latanoprost in a future clinical study.