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

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.

Herpes simplex and herpes zoster eye disease: presentation and management at a city hospital for the underserved in the United States.

OBJECTIVE: To further define the spectrum of clinical disease and treatment among patients with herpes zoster ophthalmicus (HZO) and ocular herpes simplex viral (HSV) infection presenting at a large city hospital for the underserved in the United States. METHODS: Retrospective review of medical records of 64 patients (40 HZO and 24 ocular HSV infection) presenting to the Bellevue Hospital Emergency Department for the management of herpetic eye disease for which an ophthalmologic consultation was obtained from January 1, 2006, to December 31, 2011. RESULTS: The mean age of patients with HZO was 51 ± 15 years (n=40) versus 33 ± 16 years for patients with ocular HSV infection (n=24; P<0.0001). Overall, 73% of patients with HZO were aged <60 years (n=29 of 40), of whom, 90% (26 of 29) were immunocompetent. The most common decade of onset of HZO was 50 to 59 years (11 of 40, 28%). Four patients with HZO were immunocompromised (n=4 of 40; 10%), with 3 aged <60 years attributable to human immunodeficiency virus (n=3 of 29, 10%). The study included 12 patients eligible to receive the herpes zoster vaccine. None of these patients had a history of vaccination. Of the 24 patients with ocular HSV infection, corneal stromal disease was present in 7 patients and infectious epithelial keratitis in 10 patients. No patients were treated with long-term oral antiviral prophylaxis. CONCLUSIONS: Acute HZO was seen more commonly than ocular HSV infection. Patients with HZO were significantly older than those with ocular HSV infection. Available prevention modalities, such as the vaccine against herpes zoster and long-term oral antiviral therapy to reduce ocular HSV infection recurrence, were underused.