Dataset Information

Bimatoprost 0.03% for the Treatment of Eyebrow Hypotrichosis.

ABSTRACT: Eyebrow loss may have substantial negative functional and social consequences.Evaluate the safety and efficacy of bimatoprost 0.03% in subjects with eyebrow hypotrichosis.This multicenter, double-masked study randomized adult females or males with eyebrow hypotrichosis to receive bimatoprost 0.03% twice (BID) or once daily (QD) or vehicle BID for 7 months. Primary endpoint was overall eyebrow fullness at Month 7. Secondary endpoints included eyebrow fullness (mm), darkness (intensity units), and subject satisfaction with treatment. Safety was also assessed.At Month 7, the proportion of subjects with improvement was significantly higher in bimatoprost groups versus vehicle (both, p < .001). Improvements occurred in both bimatoprost groups versus vehicle after Month 1 and continued through follow-up; eyebrow fullness and darkness improved as early as Months 2 and 1, respectively (both, p < .001). Greater satisfaction was reported with bimatoprost versus vehicle at Month 2 and all subsequent time points. Overall, 38.1%, 42.4%, and 35.5% of subjects in the bimatoprost BID, QD, and vehicle groups, respectively, experienced ?1 treatment-emergent adverse event (TEAE). Most frequent TEAEs were similar across groups. No skin or iris hyperpigmentation or conjunctival hyperemia occurred.Bimatoprost 0.03% BID and QD is safe, well tolerated, and effective for eyebrow hypotrichosis.

SUBMITTER: Carruthers J

PROVIDER: S-EPMC5414776 | biostudies-literature | 2016 May

REPOSITORIES: biostudies-literature

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Bimatoprost 0.03% for the Treatment of Eyebrow Hypotrichosis.

Carruthers Jean J Beer Kenneth K Carruthers Alastair A Coleman William P WP Draelos Zoe Diana ZD Jones Derek D Goldman Mitchel P MP Pucci Michael L ML VanDenburgh Amanda A Weng Emily E Whitcup Scott M SM

Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.] 20160501 5

<h4>Background</h4>Eyebrow loss may have substantial negative functional and social consequences.<h4>Objective</h4>Evaluate the safety and efficacy of bimatoprost 0.03% in subjects with eyebrow hypotrichosis.<h4>Methods</h4>This multicenter, double-masked study randomized adult females or males with eyebrow hypotrichosis to receive bimatoprost 0.03% twice (BID) or once daily (QD) or vehicle BID for 7 months. Primary endpoint was overall eyebrow fullness at Month 7. Secondary endpoints included e ...[more]

PMID: 27124878

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Project description:BACKGROUND:The purpose of this study was to evaluate the intraocular pressure (IOP)-lowering efficacy and safety of bimatoprost 0.01% or 0.03% as monotherapy in patients treated with latanoprost 0.005% monotherapy who require additional IOP lowering for their ocular hypertension or open-angle glaucoma. METHODS:Two prospective, investigator-masked, randomized, parallel-group, multicenter studies enrolled patients with baseline IOP ?20 mmHg after ?30 days of latanoprost 0.005% monotherapy. Patients were randomized to 12 weeks of study treatment (study 1, bimatoprost 0.01% once daily or bimatoprost 0.01% once daily plus brimonidine 0.1% three times daily; study 2, bimatoprost 0.03% once daily or bimatoprost 0.03% once daily plus fixed-combination brimonidine 0.2%/timolol 0.5% twice daily). Patient evaluations at weeks 4 and 12 included IOP at 8 am, 10 am, and 4 pm and safety assessments. Results in the monotherapy study arms (bimatoprost 0.01% or 0.03%) are presented. RESULTS:Latanoprost-treated baseline mean diurnal IOP (± standard error of the mean) was 22.2±0.3 mmHg and 22.1±0.4 mmHg in the bimatoprost 0.01% and bimatoprost 0.03% treatment arms, respectively (P=0.957). In both treatment arms, mean (± standard error of the mean) reduction in IOP from latanoprost-treated baseline was statistically significant at each time point at both follow-up visits (P<0.001), ranging from 3.7±0.4 (17.0%) mmHg to 4.4±0.4 (19.9%) mmHg with bimatoprost 0.01% and from 2.8±0.5 (12.8%) mmHg to 3.9±0.5 (16.7%) mmHg with bimatoprost 0.03%. Mean percentage IOP reduction from latanoprost-treated baseline was numerically greater with bimatoprost 0.01% than with bimatoprost 0.03% throughout follow-up. The incidence of conjunctival hyperemia of mild or greater severity increased from latanoprost baseline after 12 weeks of treatment only in the bimatoprost 0.03% treatment arm. CONCLUSION:Many patients who do not reach their target IOP on latanoprost can achieve additional IOP lowering and maintain monotherapy by replacing latanoprost with bimatoprost. Reductions in IOP from latanoprost baseline were larger with bimatoprost 0.01% than with bimatoprost 0.03%, and bimatoprost 0.01% had a more favorable tolerability profile.

Project description:IntroductionFixed-combination bimatoprost 0.03%/timolol 0.5% ophthalmic solution (FCBT; Ganfort®, Allergan, an AbbVie company) effectively reduces intraocular pressure (IOP) via complementary mechanisms of action of the agents, but long-term (> 12 weeks) safety evaluations of FCBT remain limited. FCBT safety is evaluated herein, with particular focus on hyperemia and eyelash growth, at 24 weeks in Chinese patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).MethodsIn this multicenter, open-label, noncomparative, phase 4 study conducted in China, patients diagnosed with OAG or OHT having insufficient response to β-blocker- or prostaglandin analogue/prostamide (PGA)-based IOP-lowering monotherapy in one or both eyes were switched from their current IOP-lowering treatment to FCBT (one drop per eye every evening) without prior washout. Assessment visits were scheduled at baseline and weeks 4, 12, and 24 (or study exit). The primary outcome measure was adverse event (AE) incidence through 24 weeks.ResultsOf 725 patients enrolled, 632 (87.2%) completed the study; 93 (12.8%) patients discontinued, including 29 (4.0%) due to AEs. Of 1326 FCBT-treated eyes (total), 594 (44.8%) experienced ≥ 1 ocular treatment-related AE during the study. Conjunctival hyperemia (the most common AE overall) and eyelash growth were reported in 269 (20.3%) and 54 (4.1%) FCBT-treated eyes, respectively. The incidence of other known PGA-related AEs (including blepharal pigmentation and erythema of eyelid) was < 10% each. Most conjunctival hyperemia reports were mild in severity (214/259; 82.6%) and only 1/259 (0.4%) was severe. Similarly, most cases of eyelash growth were mild (46/52; 88.5%); none were severe. One (< 0.1%) FCBT-treated eye had a serious ocular AE (OAG) considered FCBT-related.ConclusionsThe frequency and severity of FCBT-related AEs, including conjunctival hyperemia and eyelash growth, are consistent with previously published findings. No new safety concerns were raised. This prospective study reaffirms that once-daily FCBT is a safe and well-tolerated therapy for OAG and OHT.ClinicaltrialsGov identifierNCT02571712.

Dataset Information

Bimatoprost 0.03% for the Treatment of Eyebrow Hypotrichosis.

Publications

Bimatoprost 0.03% for the Treatment of Eyebrow Hypotrichosis.

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