Efficacy and Safety of Lotilaner Ophthalmic Solution 0.25% for the Treatment of Demodex Blepharitis: A Meta-Analysis of Randomized Controlled Trials.

PURPOSE: Demodex blepharitis, often overlooked in ocular surface disease, involves Demodex mites, prevalent ectoparasites on human skin. Current treatments may not effectively eliminate these mites, prompting a need for targeted therapies. Lotilaner, an antiparasitic agent, shows promise. This systematic review and meta-analysis assesses 0.25% lotilaner ophthalmic solution's efficacy in reducing Demodex mite populations and its impact on ocular surface inflammation in Demodex blepharitis patients. METHODS: A comprehensive literature search was performed in the PubMed and Cochrane Library databases from inception until February 2024 to identify relevant trials investigating the use of lotilaner in patients with Demodex blepharitis. The included studies were assessed for quality, and a meta-analysis was conducted to determine the overall treatment effects of lotilaner. Odds ratios (OR) and 95% confidence intervals (CIs) were calculated for binary variables. All statistical analyses were performed using the R Statistical Software. RESULTS: Five studies met the inclusion criteria and were included in this systematic review and meta-analysis. Lotilaner demonstrated significant efficacy in Collarette Cure [OR = 6.64; 95 % CI 3.78 to 11.04; p < 0.00001, I2 = 62 %] %], clinically meaningful collarette reduction [OR = 6.21; 95 % CI 3.67 to 10.49; p < 0.00001, I2 = 90 %], and achieving at least 1-grade collarette improvement [OR = 5.12; 95 % CI (2.96 to 8.88); p < 0.00001, I2 = 90 %] compared to the placebo group. The treatment also resulted in mite eradication [OR = 6.18; 95 % CI 4.67 to 6.18; p < 0.00001, I2 = 34 %], reduction in mite density [OR = 9.37; 95 % CI 5.36 to 16.36; p < 0.00001, I2 = 84 %], and erythema cure [OR = 2.29; 95 % CI 2.24 to 3.39; p < 0.00001, I2 = 5 %] and composite cure [OR = 7.05; 95 % CI 3.66 13. 61; p < 0.00001, I2 = 11 %]. The study suggests that lotilaner is a promising therapeutic option for collarette and associated symptoms, but the high heterogeneity in some outcomes and limited long-term data warrant further research to confirm its effectiveness and safety. CONCLUSION: This systematic review and meta-analysis provides robust evidence supporting the efficacy of 0.25% lotilaner ophthalmic solution in treating Demodex blepharitis. Approval of this targeted therapy represents a significant milestone in ophthalmology and offers a promising treatment option for patients with Demodex blepharitis. Eye care professionals should consider the potential benefits of lotilaner in managing and alleviating the symptoms associated with Demodex infestations on the eyelids. Further research and long-term follow-up studies are warranted to assess the safety and effectiveness of lotilaner in treating Demodex blepharitis.

Role of Topical 5-Fluorouracil in Demodex -Associated Blepharitis.

PURPOSE: The aim of this study was to report clinical observations suggesting the efficacy of topical 1% 5-fluorouracil (5-FU) in treating Demodex -associated blepharitis. METHODS: An observational retrospective review of 13 eyes from 13 individuals with conjunctival neoplastic lesions and concomitant Demodex lash infestation that received topical 1% 5-FU eye drops. Patients underwent slit-lamp examination at each follow-up visit. Clinical photographs of the lash line were obtained after treatment initiation. In a subset of patients, lashes were epilated bilaterally and microscopically analyzed for presence of Demodex mites before and after treatment initiation. RESULTS: The mean age of the population was 68 ± 14 years (range: 30-84 years) and 92% were male. In all 13 patients, a marked reduction in cylindrical dandruff was noted in the treated eye by slit-lamp examination after 2 cycles of 5-FU. There was complete resolution of cylindrical dandruff in 10 of 13 treated eyes compared with 0 resolution of cylindrical dandruff in untreated eyes ( P = 0.0001). In the 6 patients who received epilation, the lashes from the treated eye showed no Demodex , whereas lashes from the fellow untreated eye revealed persistent Demodex . CONCLUSIONS: Topical 1% 5-FU shows efficacy in treating Demodex -associated blepharitis. Further studies are indicated to reproduce our findings and evaluate the potential use of 5-FU as a treatment ingredient.

Comorbidity of Ocular and Facial Demodicosis.

PURPOSE: To determine the association between ocular and facial demodicosis, and the effect of facial treatment on ocular demodicosis. DESIGN: Prospective clinical cohort study. METHODS: Ocular demodicosis outpatients from a tertiary medical center were enrolled from April to December 2020. The diagnosis was based on epilation of 4 eyelashes from each upper eyelid. High ocular Demodex load (ODL) was defined as ≥8 mites per eye. Facial infestation was assessed by direct microscopic examination, with facial Demodex overgrowth (FDO) defined as a density >5 mites/cm2. All patients were prescribed 3 months of ocular treatment, and FDO patients received dermatologic treatment. RESULTS: Eighty-nine patients were enrolled. Among those that completed the treatment course, 39 presented high ODL. Lower cylindrical sleeve counts were found in low ODL patients (low ODL vs high ODL: 8 vs 14, P = .009). FDO was less prevalent in this group (49% vs 77%, P = .012). The Ocular Surface Disease Index score decreased in patients without FDO (20.0 ± 17.1 to 14.0 ± 16.6, P = .027) after 3 months of topical tea tree oil treatment. Topical ivermectin treatment on the facial skin provided a higher ocular Demodex eradication rate in FDO patients (76% vs 16%, P < .001). CONCLUSION: Concurrence of ocular and facial demodicosis is common, especially in cases of severe ocular demodicosis. Although ocular treatment alone is effective for patients with ocular demodicosis only, cotreatment with topical ivermectin on the facial skin enhances ocular Demodex eradication in patients with comorbid facial Demodex overgrowth.

Case Report: Three-Day Albendazole Regimen for Orbital Cysticercosis and the Stardust Sign.

Ultrasonography findings have been used to diagnose and treat 10 cases of orbital cysticercosis. Although oral prednisolone has a key role in symptomatic alleviation, 3-day albendazole has been demonstrated to be curative without any recurrence.

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.

Is Demodex Blepharitis Connected With Cataract Surgery?

PURPOSE: To determine whether there is an increased incidence of Demodex of the eyelashes among patients after cataract extraction surgery. DESIGN: Prospective, noncomparative clinical study. METHODS: A cohort of patients who underwent cataract extraction surgery had several eyelashes removed preoperatively that were examined independently by the hospital laboratory for the presence of the Demodex mite. This was repeated 3 weeks after surgery. During several postoperative weeks, patients received the standard treatment of steroid drops alone for a period as individually required. RESULTS: A total of 62 patients were included in the study (31 men and 31 women), with a mean age of 71.04 years (range, 47-87). In the group positive for Demodex, the male-to-female ratio was 2:3 (P = .2772). Demodex colonization was observed in 22.58% of samples before cataract surgery and in 32.26% after cataract surgery and topical postoperative steroid therapy (P = .0143). CONCLUSIONS: There is a statistically significant increase in Demodex colonization of eyelashes after cataract surgery and postoperative topical steroid treatment. Although Demodex colonization does not necessarily cause blepharitis, our findings of increased colonization should raise the possibility of Demodex blepharitis being considered by ophthalmologists in patients with chronic postoperative eye discomfort after cataract surgery. This study was carried out at the Emek Medical Center.

Annoying Conjunctival Thelaziasis in a Patient Aged 81 Years.

This case report discusses a diagnosis of thelaziasis in a female patient aged 81 years who presented with a foreign body sensation in the left eye for 1 month.

Treatment of Demodex Blepharitis: A Prospective, Randomized, Controlled, Double-Masked Clinical Trial Comparing Topical Lotilaner Ophthalmic Solution, 0.25% Eyedrops to Vehicle.

PURPOSE: To evaluate the efficacy and safety of lotilaner ophthalmic solution, 0.25% eyedrops compared to vehicle for the treatment of Demodex blepharitis. METHODS: In this randomized, controlled, double-masked clinical trial, 54 participants were randomly assigned in a 1:1 ratio to receive either lotilaner ophthalmic solution, 0.25% (study group) or the vehicle (control group) bilaterally, twice daily for 42 days. Outcome measures were collarette cure (collarette grade 0, upper eyelid), mite eradication (mite density of 0 mites/lash), and composite cure (grade 0 for collarettes and erythema). RESULTS: The proportion of participants achieving collarette cure (80.0% vs 15.8%; p < .001), mite eradication (73.3% vs 21.1%, p = .003) and composite cure (73.3% vs 10.5%, p < .001) at Day 42 was statistically significantly higher in the study group than the control group. CONCLUSION: Twice-daily 42-day treatment with novel lotilaner ophthalmic solution, 0.25% is safe and effective for the treatment of Demodex blepharitis compared to the vehicle control. (Registry number: ACTRN12620000320954, dated 09/03/2020).

Recent Evidence of Tea Tree Oil Effectiveness in Blepharitis Treatment.

The purpose of our study is to see how beneficial is tea tree oil (TTO) for treating chronic blepharitis topically, with a focus on the Demodex mite. To discover all possibly relevant published papers, an accurate Pubmed database search analysis of the current literature was undertaken from 2012 to December 2021. Fourteen papers dealing with the use of TTO to treat chronic blepharitis have been found. The effectiveness of TTO treatment was tested in vitro by 4 authors and in vivo by 10 authors. All studied confirmed efficacy of TTO treatment, even cyclic, on Demodex mite blepharitis. TTO can be used for lid scrubs, facial cleanser, eyelid patch, eyelid gel, eyelash shampoo or, more commonly, as TTO impregnated eyelid wipes. The scientific evidence of TTO for chronic blepharitis treatment gives a lot of confidence for the progress that this treatment may have in the future clinical practice.

Ophthalmomyiasis externa caused by Oestrus ovis.

This report describes the case of a woman in her early 20s who presented with a 3-day history of mobile foreign bodies and watering from her right eye. She had recently returned from vacation on a Greek island and presented to an ophthalmology unit in London, UK. A sample taken demonstrated Oestrus ovis infestation and confirmed the diagnosis of ophthalmomyiasis externa. She was treated with prophylactic topical antibiotics and subsequently made a full recovery. This was only the sixth presentation of O. ovis ophthalmomyiasis externa documented within the UK and the only case documented within the last 20 years. This is the fifth documented case found to have been transmitted within Greece.

Amoebicidal Activity of Poly-Epsilon-Lysine Functionalized Hydrogels.

Purpose: To determine the amoebicidal activity of functionalized poly-epsilon-lysine hydrogels (pɛK+) against Acanthamoeba castellanii. Methods: A. castellanii trophozoites and cysts were grown in the presence of pɛK solution (0-2.17 mM), pɛK or pɛK+ hydrogels, or commercial hydrogel contact lens (CL) for 24 hours or 7 days in PBS or Peptone-Yeast-Glucose (PYG) media (nutrient-deplete or nutrient-replete cultures, respectively). Toxicity was determined using propidium iodide and imaged using fluorescence microscopy. Ex vivo porcine corneas were inoculated with A. castellanii trophozoites ± pɛK, pɛK+ hydrogels or commercial hydrogel CL for 7 days. Corneal infection was assessed by periodic acid-Schiff staining and histologic analysis. Regrowth of A. castellanii from hydrogel lenses and corneal discs at 7 days was assessed using microscopy and enumeration. Results: The toxicity of pɛK+ hydrogels resulted in the death of 98.52% or 83.31% of the trophozoites at 24 hours or 7 days, respectively. The toxicity of pɛK+ hydrogels resulted in the death of 70.59% or 82.32% of the cysts in PBS at 24 hours or 7 days, respectively. Cysts exposed to pɛK+ hydrogels in PYG medium resulted in 75.37% and 87.14% death at 24 hours and 7 days. Ex vivo corneas infected with trophozoites and incubated with pɛK+ hydrogels showed the absence of A. castellanii in the stroma, with no regrowth from corneas or pɛK+ hydrogel, compared with infected-only corneas and those incubated in presence of commercial hydrogel CL. Conclusions: pɛK+ hydrogels demonstrated pronounced amoebicidal and cysticidal activity against A. castellanii. pɛK+ hydrogels have the potential for use as CLs that could minimize the risk of CL-associated Acanthamoeba keratitis.

Demodex Blepharitis: An Analysis of Nine Patients.

Inflammatory eyelid symptoms are common in primary care and there have been several reports on Demodex blepharitis. In the present study, we evaluate the 9 patients with Demodex blepharitis, who showed inflammation of the eyelids, dry eye, and cylindrical dandruff at the base of the eyelashes. The causative species from all patients was Demodex folliculorum of either the adult or nymph stage. Two patients had recurrent chalazion and 3 patients had keratitis. Weekly lid scrubs with 50% tee tree oil were performed for 6 weeks. After treatment, the symptoms of blepharitis and keratitis had improved in all patients. This case report provides clinical reference source for the proper treatment of ocular demodicosis.

Efficacy of Topical Ivermectin 1% in the Treatment of Demodex Blepharitis.

PURPOSE: The purpose of this study was to evaluate the efficacy of topical ivermectin 1% cream application on the eyelashes in combination with eyelid hygiene in the treatment of Demodex blepharitis. METHODS: One hundred two eyes of 102 patients with symptomatic Demodex blepharitis were divided into 2 groups according to the use of topical ivermectin in this retrospective case-control study. The ivermectin group (n = 51) applied topical ivermectin 1% cream on the eyelashes for 15 minutes once weekly, but the control group (n = 51) did not. In both groups, eyelid hygiene was performed once daily. The Standard Patient Evaluation of Eye Dryness (SPEED) symptom questionnaire score, Oxford staining score, eyelid debris, eyelid redness/swelling, and telangiectasia were assessed during the follow-up visits. RESULTS: The mean follow-up periods of the ivermectin and control groups were 15.1 ± 9.7 weeks and 14.8 ± 8.6 weeks, respectively. The SPEED score and eyelid debris grade were significantly improved in both groups during the follow-up, although the SPEED score and eyelid debris grade showed greater changes in the ivermectin group than in the control group. The Oxford staining score, eyelid redness/swelling grade, and telangiectasia grade were significantly improved only in the ivermectin group but not in the control group. CONCLUSIONS: In patients with Demodex blepharitis, the use of topical ivermectin 1% cream for 15 minutes once weekly in addition to eyelid hygiene had more significantly improved symptoms, ocular surface staining, eyelid debris, redness/swelling, and telangiectasia as compared with eyelid hygiene alone. These findings support the efficacy of topical ivermectin 1% cream application in the treatment of Demodex blepharitis.

Different Approach to Manage Demodex Blepharitis - Initial and Maintenance Treatment.

PURPOSE/AIM OF THE STUDY: To evaluate the improvement of ocular signs and symptoms in patients suffering from Demodex blepharitis using a combined treatment approach: use of eyelid wipes impregnated with 2.5% terpinen-4-ol (T4O) and 0.2% hyaluronic acid (HA) in the initial treatment period and investigation of maintenance of the treatment effect with the use of eyelid cleansing wipes. MATERIALS AND METHODS: Fifty patients with Demodex blepharitis were treated in the initial treatment period with sterile eyelid T4O impregnated wipes for 28 days. In the following four-week maintenance period, 82% patients received sterile eyelid maintenance wipes, while 16% continued treatment with T4O impregnated wipes. Global ocular discomfort, adapted TOSS, SANDE score, and individual blepharitis symptoms were assessed by patients at day 28 and day 56. Ocular signs were evaluated by the investigator at the study visits. Investigator's assessment of the overall treatment performance, patient's assessment of treatment satisfaction, and tolerability were evaluated with questionnaires. RESULTS: All global ocular discomfort symptoms and disease specific symptoms assessed by patients as well as all parameters evaluated by the investigators significantly improved in the initial treatment period with the application of eyelid wipes impregnated with 2.5% terpinen-4-ol until day 28. The therapeutic effect was maintained or even improved during the maintenance period under administration of mainly eyelid maintenance wipes until day 56. Both products were well tolerated. No adverse events and no clinically relevant changes in visual acuity were observed during both periods. CONCLUSIONS: Once daily treatment with T4O impregnated eyelid wipes in the initial treatment period significantly improved the ocular symptoms and signs and reduced the mite count in patients with Demodex blepharitis within four-weeks administration. Subsequent maintenance treatment with maintenance wipes for another 4 weeks preserved or further intensified the treatment success. The products were well tolerated and were convenient to use.

Update on the Management of Demodex Blepharitis.

ABSTRACT: Demodex blepharitis is a common ophthalmologic disease that is often overlooked in the workup of blepharitis. Demodex infestation occurs in both symptomatic and asymptomatic individuals at similar rates; consequently, its role in the development of blepharitis has not been well elucidated. Two species have been confirmed to inhabit the human eyelid- Demodex folliculorum and Demodex brevis. These species differ in their preferred location of infestation, with D. folliculorum occupying the base of the eyelash and D. brevis inhabiting the meibomian glands, contributing to anterior and posterior Demodex blepharitis, respectively. A clinical index of suspicion must be developed from the history when blepharitis, conjunctivitis, or keratitis in adults and blepharoconjunctivitis or chalazia in children are resistant to treatment. The diagnosis can be strongly suspected by the presence of cylindrical dandruff at the base of the eyelash and confirmed by light microscopy of an epilated lash or by in vivo confocal microscopy. No cure is currently available. Management most frequently includes topical tea tree oil and its active ingredient terpinen-4-ol, both of which have produced good clinical outcomes. Topical tea tree oil is typically applied by a professional due to risk of toxicity. Several second-line treatment options have been studied, including ivermectin, metronidazole, selenium sulfide, microblepharoexfoliation, and lid hygiene. Novel, targeted therapies such as TP-03 (Tarsus Pharmaceuticals) are also currently being investigated in phase 2b/3 clinical trials. The purpose of this review purpose is to characterize Demodex blepharitis in detail, including its historical perspective and various classifications, and describe the latest diagnostic and management strategies.

[Multimodal imaging in toxoplasmic external punctate retinitis: about a case]. / Imagerie multimodale dans la rétinite ponctuée externe toxoplasmique: à propos d'un cas.

Punctuate Outer Retinal Toxoplasmosis (PORT) is a rare variant of toxoplasma chorioretinitis. We report the case of a 21-year-old patient presenting with visual blur of the left eye (LE). The examination found a corrected visual acuity (VA) at 3/10th, a quit anterior segment and a 1+ vitreous haze. Fundus examination showed a suprafoveolar yellowish-white lesions associated to multiple peripheral atrophic and pigmented ones. Visual acuity of the right eye was 10/10th with a calm anterior segment. Fundus examination depicted an upper temporal cicatricial pigmented lesion. Multimodal imaging of LE objectified a PORT. The patient received antibiotic and corticosteroids with favorable clinical and functional outcome. Final VA reached 10/10 at day ten. This case illustrates the importance of multimodal imaging in the differentiation of PORT from the white dots syndrome and other unilateral retinitis.

Severe Keratitis Caused by Acanthamoeba Genotype T12 in Thailand: A Case Report.

Acanthamoeba keratitis is predominantly caused by genotype T4. We report a case of severe keratitis caused by Acanthamoeba in a 39-year-old man who had prior accidental exposure to a corrosive chemical. The patient developed central full thickness ring infiltration and epithelial defect with hypopyon that required keratoplasty. The acanthamoebae isolated from the patient exhibited thermotolerance phenotype with the capability to grow well at ambient temperature and at 42°C. Analysis of a near complete 18S rRNA gene of this isolate revealed a distinct sequence that can be unequivocally assigned to genotype T12, a rare genotype incriminated in corneal infections.

Corneal Effects of Tea Tree Oil.

PURPOSE: The purpose of this study is to report a case of corneal epithelial defects resulting from topical treatment of blepharitis with tea tree oil (TTO). METHODS: A 44-year-old man with a 1 year history of blepharitis non-responsive to eyelid hygiene was found to have signs of Demodex infestation. He was treated with a topical, off-label 50% TTO solution. Shortly afterward, the patient complained of bilateral ocular discomfort. RESULTS: Slit-lamp examination revealed conjunctival injection and a corneal epithelial defect in both eyes. Treatment with lubricant, antibiotic, and steroid eye drops as well as bandage contact lenses was required to facilitate corneal healing. CONCLUSIONS: Topical use of off-label, 50% concentration TTO can result in corneal epithelial defects. Eye care professionals should remain aware of this risk and only use approved, low-concentration TTO products when treating Demodex-related blepharitis.