Bimatoprost for eyelash growth in Japanese subjects: two multicenter controlled studies

Abstract

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≤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 .

Trial registration: ClinicalTrials.gov NCT00907426.

Fig. 1

Percentage of subjects in study 1 with at least a one-grade improvement in Global Eyelash Assessment score. The study treatment was applied once nightly for 4 months. The subjects did not use the study treatment between months 4 and 5. *P = 0.008. ^† P < 0.001 versus vehicle

Fig. 2

Example of subjects from a study 1 and b study 2 who responded to bimatoprost treatment with two- and one-grade improvements, respectively, in Global Eyelash Assessment (GEA) score at month 4

Fig. 3

Mean changes from baseline (± 2 times standard error) in a upper eyelash length, b thickness, and darkness in study 1. The study treatment was applied once nightly for 4 months. The subjects did not use the study treatment between months 4 and 5. A negative change in eyelash darkness indicates darkening. *P = 0.012. ^† P < 0.001 versus vehicle

Fig. 4

Examples of subjects who responded to bimatoprost treatment with an increase in a upper eyelash length, b thickness, and c darkness, including baseline and month 4, as well as a change from baseline values (measurements are rounded to the nearest whole number). The individual changes in these subjects were comparable with the mean changes observed in the bimatoprost group in a study 1 and b study 2. IU intensity units