Trial reportCornea2023
Lotilaner Ophthalmic Solution, 0.25%, for the Treatment of Demodex Blepharitis: Results of a Prospective, Randomized, Vehicle-Controlled, Double-Masked, Pivotal Trial (Saturn-1).
Trial report in Cornea, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07451678 (Treatment of Blepharitis Induced by Demodex Folliculorum Through Eyelid Cleansing With Wipes Containing Topical Chlorhexidine), which is not on this map. Cited by 23 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Treatment of Blepharitis Induced by Demodex Folliculorum Through Eyelid Cleansing With Wipes Containing Topical Chlorhexidine
Who cites it
23 citing papers in PubMed, 47 citations in OpenAlex.
- Early Ocular-Surface Changes During Dupilumab Treatment According to Hyaluronic Acid Use: A Prospective Cohort Study.Journal of personalized medicine · 2026Article
- Ivermectin in the Management of Demodex -associated Blepharitis: A Comprehensive Literature Review.Eye & contact lens · 2026Review
- Redefining Dry Eye Disease Management: Emerging Pharmacologic and Device-Based Therapies in the Era of Precision Care: A Narrative Review.Ophthalmology and therapy · 2026Review
- Using Lotilaner Ophthalmic Solution, 0.25% to TreatClinical optometry · 2026Article
- Lotilaner ophthalmic solution 0.25% in the treatment ofSAGE open medical case reports · 2026Article
- Impact of lotilaner ophthalmic solution 0.25% on disease severity in patients withFrontiers in medicine · 2026Article
- Effects of Lotilaner Ophthalmic Solution, 0.25% onClinical ophthalmology (Auckland, N.Z.) · 2026Article
- High Prevalence of Lash Collarettes in Patients with Atopic Dermatitis Treated with Dupilumab.Acta dermato-venereologica · 2025Article
- Safety and Efficacy of Lotilaner Ophthalmic Solution (0.25%) in Treating Demodex Blepharitis: Pooled Analysis of Two Pivotal Trials.Ophthalmology and therapy · 2025Article
- TheClinical ophthalmology (Auckland, N.Z.) · 2025Article
- Efficacy and Safety of Lotilaner Ophthalmic Solution 0.25% in Demodex Blepharitis: A Systematic Review.HCA healthcare journal of medicine · 2025Review
- Intense Pulsed Light Combined with Low Level Blue and Red Light Therapy forClinical ophthalmology (Auckland, N.Z.) · 2025Article
- Efficacy of 1% Povidone-Iodine in the Treatment of Anterior Blepharitis-Randomized Single-Center Controlled Trial.Journal of clinical medicine · 2024Article
- Multidisciplinary perspectives inJournal of managed care & specialty pharmacy · 2024Review
- Lotilaner Ophthalmic Solution, 0.25%, for the Treatment ofHealthcare (Basel, Switzerland) · 2024Review
- A year in pharmacology: new drugs approved by the US Food and Drug Administration in 2023.Naunyn-Schmiedeberg's archives of pharmacology · 2024Review
- Tolerability of Current Treatments for Dry Eye Disease: A Review of Approved and Investigational Therapies.Clinical ophthalmology (Auckland, N.Z.) · 2024Review
- Review
- Emerging Medical Therapies in Rosacea: A Narrative Review.Dermatology and therapy · 2023Review
- Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThe purpose of this study was to evaluate the safety and efficacy of lotilaner ophthalmic solution, 0.25%, compared with vehicle for the treatment of Demodex blepharitis.
methodsIn this prospective, randomized, controlled, double-masked, phase 2b/3 clinical trial, 421 patients with Demodex blepharitis were randomly assigned in a 1:1 ratio to receive either lotilaner ophthalmic solution, 0.25% (study group), or vehicle without lotilaner (control group) bilaterally, twice daily for 43 days. Patients were evaluated at days 8, 15, 22, and 43. Outcome measures were complete collarette cure (collarette grade 0), clinically meaningful collarette cure (grade 0 or 1), mite eradication (0 mites/lash), erythema cure (grade 0), composite cure (grade 0 for collarettes/erythema), and drop comfort. Adverse events were also evaluated.
resultsAt day 43, the study group achieved a statistically significantly higher proportion of patients with clinically meaningful collarette cure (81.3% vs. 23.0%; P < 0.0001), complete collarette cure (44.0% vs. 7.4%; P < 0.0001), mite eradication (67.9% vs. 17.6%; P < 0.0001), erythema cure (19.1% vs. 6.9%; P = 0.0001), and composite cure (13.9% vs. 1.0%; P < 0.0001) than the control group. Nearly 92.0% of patients rated the study drop as neutral to very comfortable. All ocular adverse events in the study group were mild, with the most common being instillation site pain.
conclusionsTwice-daily treatment with a novel lotilaner ophthalmic solution, 0.25% for 43 days, is safe and effective for the treatment of Demodex blepharitis compared with the vehicle control.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.