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  • Twice-daily lotilaner...

Twice-daily lotilaner ophthalmic solution effective treatment of patients with Demodex blepharitis

Written By : Dr. Shravani Dali |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2023-06-26T20:00:12+05:30  |  Updated On 26 Jun 2023 8:00 PM IST
Twice-daily lotilaner ophthalmic solution effective treatment of patients with Demodex blepharitis
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Twice-daily treatment with lotilaner ophthalmic solution,holds promise for the effective treatment of patients with Demodex blepharitis suggests a new study published in the Opthalmology.

A study was done to evaluate the safety and efficacy of lotilaner ophthalmic solution, 0.25% compared to the vehicle for the treatment of Demodex blepharitis.

Four hundred and twelve (412) Demodex blepharitis patients were randomly assigned in a 1:1 ratio to receive either lotilaner ophthalmic solution, 0.25% (study group) or vehicle without lotilaner (control group).

In this study, conducted at 21 U.S. clinical sites, Demodex blepharitis patients assigned to the study group (N=203) received lotilaner ophthalmic solution, 0.25% and those in the control group (N=209) received vehicle without lotilaner bilaterally, twice daily for six weeks. Patients were evaluated on Days 8, 15, 22, and 43. Collarettes and erythema were graded for each eyelid at screening and at all post-baseline visits. 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.

Outcome measures included collarette cure (collarette grade 0), clinically meaningful collarette reduction to ≤10 collarettes (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 (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.


Twice-daily treatment with lotilaner ophthalmic solution, 0.25% for 6 weeks was generally safe and well tolerated and met the primary endpoint and all secondary endpoints for the treatment of Demodex blepharitis compared to the vehicle control.

Reference:

Ian Benjamin Gaddie, Eric D. Donnenfeld, Paul Karpecki, John Meyer, Elizabeth Yeu, Saturn II Study Group. Lotilaner Ophthalmic Solution, 0.25% for Demodex Blepharitis: Randomized, Vehicle-Controlled, Multicenter, Phase 3 Trial (Saturn-2). Published:June 05, 2023DOI:https://doi.org/10.1016/j.ophtha.2023.05.030

StudyGroupLotilanerOphthalmicSolution0.25%DemodexBlepharitisRandomizedVehicle-ControlledMulticenterPhase 3 TrialOpthalmology
Source : Opthalmology
Dr. Shravani Dali
Dr. Shravani Dali

    Dr. Shravani Dali has completed her BDS from Pravara institute of medical sciences, loni. Following which she extensively worked in the healthcare sector for 2+ years. She has been actively involved in writing blogs in field of health and wellness. Currently she is pursuing her Masters of public health-health administration from Tata institute of social sciences. She can be contacted at editorial@medicaldialogues.in.

    Dr. Kamal Kant Kohli
    Dr. Kamal Kant Kohli

    Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751

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