Lotilaner Ophthalmic Solution 0.25% for Demodex Blepharitis: Randomized, Vehicle-Controlled, Multicenter, Phase 3 Trial (Saturn-2).

Autor:	Gaddie IB; Gaddie Eye Centers, Louisville, Kentucky., Donnenfeld ED; OCLI Vision, Garden City, New York., Karpecki P; Kentucky Eye Institute, Lexington, Kentucky., Vollmer P; Vita Eye Clinic, Shelby, North Carolina., Berdy GJ; Ophthalmology Associates, St. Louis, Missouri., Peterson JD; Mountain View Eye Center, Layton, Utah., Simmons B; Vision Institute, Colorado Springs, Colorado., Edell ARP; East Bay Eye Centers, San Ramon, California., Whitson WE; Whitson Vision, Indianapolis, Indiana., Ciolino JB; Department of Ophthalmology, Harvard Medical School, Boston, Massachusetts., Baba SN; Tarsus Pharmaceuticals, Inc., Irvine, California., Holdbrook M; Tarsus Pharmaceuticals, Inc., Irvine, California., Trevejo J; Tarsus Pharmaceuticals, Inc., Irvine, California., Meyer J; The Eye Care Institute, Louisville, Kentucky., Yeu E; Virginia Eye Consultants, Norfolk, Virginia. Electronic address: eyeulin@gmail.com.
Jazyk:	angličtina
Zdroj:	Ophthalmology [Ophthalmology] 2023 Oct; Vol. 130 (10), pp. 1015-1023. Date of Electronic Publication: 2023 Jun 05.
DOI:	10.1016/j.ophtha.2023.05.030
Abstrakt:	Purpose: To evaluate the safety and efficacy of lotilaner ophthalmic solution 0.25% compared with vehicle for the treatment of Demodex blepharitis. Design: Prospective, randomized, double-masked, vehicle-controlled, multicenter, phase 3 clinical trial. Participants: Four hundred twelve patients with Demodex blepharitis were assigned randomly in a 1:1 ratio to receive either lotilaner ophthalmic solution 0.25% (study group) or vehicle without lotilaner (control group). Methods: Patients with Demodex blepharitis treated at 21 United States clinical sites were assigned either to the study group (n = 203) to receive lotilaner ophthalmic solution 0.25% or to the control group (n = 209) to receive vehicle without lotilaner bilaterally twice daily for 6 weeks. Collarettes and erythema were graded for each eyelid at screening and at all visits after baseline. At screening and on days 15, 22, and 43, 4 or more eyelashes were epilated from each eye, and the number of Demodex mites present on the lashes was counted with a microscope. Mite density was calculated as the number of mites per lash. Main Outcome Measures: Outcome measures included collarette cure (collarette grade 0), clinically meaningful collarette reduction to 10 collarettes or fewer (grade 0 or 1), mite eradication (0 mites/lash), erythema cure (grade 0), composite cure (grade 0 for collarettes as well as erythema), compliance with the drop regimen, drop comfort, and adverse events. Results: At day 43, the study group achieved a statistically significant (P < 0.0001) higher proportion of patients with collarette cure (56.0% vs. 12.5%), clinically meaningful collarette reduction to 10 collarettes or fewer (89.1% vs. 33.0%), mite eradication (51.8% vs. 14.6%), erythema cure (31.1% vs. 9.0%), and composite cure (19.2% vs. 4.0%) than the control group. High compliance with the drop regimen (mean ± standard deviation, 98.7 ± 5.3%) in the study group was observed, and 90.7% of patients found the drops to be neutral to very comfortable. Conclusions: Twice-daily treatment with lotilaner ophthalmic solution 0.25% for 6 weeks generally was safe and well tolerated and met the primary end point and all secondary end points for the treatment of Demodex blepharitis compared with vehicle control. Financial Disclosure(s): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article. (Copyright © 2023 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
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