Bimatoprost in the Treatment of Eyelash Hypotrichosis
Research type
Research Study
Full title
Bimatoprost in the Treatment of Eyelash Hypotrichosis
IRAS ID
117067
Contact name
William Perkins
Eudract number
2012-003007-35
Clinicaltrials.gov Identifier
Research summary
Eyelash hypotrichosis is described as having inadequate or not enough eyelashes. The etiology of hypotrichosis may be age-related, genetic, or other undetermined cause, but is measured by a baseline Global Eyelash Assessment (GEA) score of 1 or 2.This study is a multicenter, double-masked, randomised, parallel-group, vehicle- and active controlled, 5-month study to evaluate the safety and efficacy of Bim SD in patients with idiopathic eyelash hypotrichosis. Patients will be randomised in a 2:2:1:1 ratio to receive Bim SD, Bim BA, Veh SD or Veh BA. The study treatment will be administered dermally (application to the upper eyelid margin) once daily for 4 months and patients will be followed for a further 1 month after having discontinued the study treatment. The primary efficacy measure is the GEA scale score and the primary time point is at month 4. The total duration of study participation for each patient is 5 months following randomisation and patients will attend the following 8 visits: screening, baseline (day 1), week 1, months 1, 2, 3, 4, and 5 (study exit).An estimated 454 patients will be enrolled across approximately 25 sites in the United States, Sweden, Russia and UK.The purpose of the present study is to achieve the following:?½ assess the safety and efficacy of Bim SD in increasing overall eyelash prominence in patients with hypotrichosis of the eyelashes?½ assess changes in patient satisfaction in overall eyelash appearance following treatment with Bim SD?½ use of the study data to develop a better understanding of diseases capable of being treated with bimatoprost or similar drugs and to assist in the design of future clinical trials?½ seek regulatory and/or marketing approval of bimatoprost solution 0.03% single-dose vial
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
12/EM/0439
Date of REC Opinion
14 Jan 2013
REC opinion
Further Information Favourable Opinion