Bimatoprost for Eyelash Growth in Japanese Subjects: Two Multicenter Controlled Studies

Background Bimatoprost 0.03 % has enhanced eyelash prominence in clinical trials enrolling mostly Caucasian subjects. The studies described in this report evaluated the efficacy and safety of bimatoprost in Japanese subjects with idiopathic and chemotherapy-induced eyelash hypotrichosis. Methods In two multicenter, double-masked, randomized, parallel-group studies (study 1: n = 173 [idiopathic]; study 2: n = 36 [chemotherapy-induced]), subjects received bimatoprost 0.03 % or vehicle applied once daily to the upper eyelid margins. The primary efficacy measure was eyelash prominence measured by Global Eyelash Assessment (GEA) scores. Additional measures were eyelash length, thickness, and darkness, assessed by digital image analysis, and patient satisfaction (Eyelash Satisfaction Questionnaire-9). Safety assessments included adverse-event monitoring and ophthalmic examinations. Results Significantly more bimatoprost-treated subjects had at least a one-grade improvement in GEA score from baseline to month 4 compared with vehicle in study 1 (77.3 vs 17.6 %; P < 0.001) and study 2 (88.9 vs 27.8 %; P < 0.001). Bimatoprost-treated subjects had significantly greater increases in eyelash length, thickness, and darkness at the primary time point (month 4 in both studies; all P < 0.001, study 1; P a parts per thousand currency sign 0.04, study 2). The bimatoprost group showed greater subject satisfaction in both studies. The incidence of adverse events was similar in the two groups. Ophthalmic examination showed slightly greater mean reductions in intraocular pressure (IOP) with bimatoprost than with vehicle, and the reductions were within the normal range for daily IOP fluctuations. Conclusion Bimatoprost 0.03 % was shown to be effective and safe in these studies of Japanese subjects with eyelash hypotrichosis. Level of Evidence I This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.