Clinical Trial: Latanoprost for the Treatment of Menière's Disease
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: 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
Brief Summary: The purpose of the study is to evaluate the dose regimen, efficacy and safety of latanoprost for the treatment of Menière's disease.
Detailed Summary:
Sponsor: Synphora AB
Current Primary Outcome: Change in speech discrimination score in noise from Baseline [ Time Frame: 2 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change in speech discrimination score in noise from Baseline [ Time Frame: 3 months ]
- Change in pure tone audiometry from Baseline [ Time Frame: 3 months ]
- Change in THI-25 (Tinnitus Handicap Inventory) score from Baseline [ Time Frame: 3 months ]
- Change in hearing (Likert scale), tinnitus (Likert scale) and vertigo (Likert scale) from run-in period [ Time Frame: 3 months ]
- Change in proportion of days with vertigo attacks from run-in period [ Time Frame: 3 months ]
- Comparison of number of drop attacks in each treatment arm [ Time Frame: 3 months ]
- Evaluation of adverse events and vital signs as measure of safety and tolerability [ Time Frame: 3 months ]
Original Secondary Outcome: Same as current
Information By: Synphora AB
Dates:
Date Received: October 17, 2013
Date Started: October 2013
Date Completion:
Last Updated: March 22, 2016
Last Verified: March 2016
