advertisement
Abstract #25692 Published in IGR 12-2
Eyelash growth in subjects treated with bimatoprost: A multicenter, randomized, double-masked, vehicle-controlled, parallel study
Smith S; Somogyi C; Beddingfield F; Whitcup S; Fagien SJournal of the American Academy of Dermatology 2009; 60: AB8
Background: The safety and efficacy of bimatoprost 0.03% for the treatment of ocular hypertension has been well established in multiple randomized, double-masked, controlled clinical trials. In these studies, a significant proportion of patients demonstrated increased eyelash growth. Methods: A prospective, randomized, double-masked, vehicle-controlled study was conducted to assess the efficacy and safety of bimatoprost 0.03% solution applied to the eyelid compared with vehicle in increasing eyelash prominence. A total of 278 healthy adult subjects were enrolled at 16 centers in North America. Eyelash prominence was assessed using a Global Eyelash Assessment (GEA) photonumeric scale. Secondary endpoints, including eyelash length, fullness, darkness, and patient reported outcomes, were also assessed. Results: Statistically significantly increases in GEA responder rates were seen at the third study visit through the end of study including the primary endpoint (P < .0001). Improvements from baseline in eyelash growth in length, fullness, and darkness were significantly greater in the bimatoprost group compared with the vehicle group at the primary endpoint and consistently at multiple other study visits before the primary endpoint. Subjects reported increased overall satisfaction with eyelash appearance and feelings of confidence, professionalism, and attractiveness, beginning at the third study visit (P (less-than or equal to) .005). Adverse events reported more frequently in patients receiving bimatoprost included pruritus, conjunctival hyper-emia, skin hyperpigmentation, and conjunctival hyperemia and were predominantly mild and occurred in <5% of subjects. Conclusions: Topically applied bimatoprost 0.03% solution was found to be effective in increasing eyelash prominence and in increasing growth of natural eyelashes, and was safe and well tolerated in this study population of healthy adult subjects.
S. Smith. Therapeutics Clinical Research, San DiegoUnited States.
Classification:
11.4 Prostaglandins (Part of: 11 Medical treatment)
