Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Eye Research Foundation, Inc.
Prior Safety Data
Trial Summary
What is the purpose of this trial?A Single-Center, Investigator-Masked, Randomized, Placebo-Controlled, Investigator Initiated Study of the Safety and Efficacy of Moxidectin Tablets for the Reduction of Demodex Eyelash Infestation
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the drug moxidectin for treating blepharitis?
Moxidectin has shown strong effectiveness in treating various parasitic infections in humans and animals, such as onchocerciasis and gastrointestinal nematodes, with significant reductions in parasite counts and long-lasting effects. While this data does not directly address blepharitis, it suggests moxidectin's potential as a powerful antiparasitic agent.
12345Is moxidectin generally safe for humans?
Moxidectin has been studied in humans and is generally considered safe and well-tolerated at doses between 3 mg and 36 mg, with some mild to moderate side effects like headaches and dizziness. No serious adverse events were reported in these studies.
16789How is the drug Moxidectin unique for treating blepharitis?
Moxidectin is unique for treating blepharitis because it is primarily known as an antiparasitic drug, which suggests it may work differently from other treatments like tobramycin dexamethasone or bibrocathol ointments that are more commonly used for this condition.
1011121314Eligibility Criteria
This trial is for individuals with active blepharitis, characterized by eyelid inflammation and debris (collarettes) around the lashes. It's not suitable for those with other significant eye diseases.Inclusion Criteria
I have active eyelid inflammation with crusty lashes.
Exclusion Criteria
I have a serious eye condition.
Participant Groups
The study tests if Moxidectin tablets are safe and effective in reducing Demodex mite infestation on eyelashes compared to a placebo. Participants will be randomly assigned to receive either the medication or a placebo.
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Active and PlaceboExperimental Treatment2 Interventions
Group II: ActiveActive Control1 Intervention
Group III: PlaceboPlacebo Group1 Intervention
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Eye Research Foundation, Inc.Newport Beach, CA
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Who is running the clinical trial?
Eye Research Foundation, Inc.Lead Sponsor
References
Safety and tolerability of moxidectin and ivermectin combination treatments for lymphatic filariasis in Côte d'Ivoire: A randomized controlled superiority study. [2023]Moxidectin is a macrocyclic lactone registered for the treatment of human onchocerciasis. The drug has a good safety profile, large volume of distribution and a long elimination half-life. This paper reports tolerability data from the first use of moxidectin in persons with Wuchereria bancrofti infection.
Moxidectin: an oral treatment for human onchocerciasis. [2021]Moxidectin is a milbemycin endectocide recently approved for the treatment of human onchocerciasis. Onchocerciasis, earmarked for elimination of transmission, is a filarial infection endemic in Africa, Yemen, and the Amazonian focus straddling Venezuela and Brazil. Concerns over whether the predominant treatment strategy (yearly mass drug administration (MDA) of ivermectin) is sufficient to achieve elimination in all endemic foci have refocussed attention upon alternative treatments. Moxidectin's stronger and longer microfilarial suppression compared to ivermectin in both phase II and III clinical trials indicates its potential as a novel powerful drug for onchocerciasis elimination.
Efficacy and persistent activity of moxidectin against natural Muellerius capillaris infection in goats and pathological consequences of muelleriosis. [2019]The effect of moxidectin against natural Muellerius capillaris infection in goats was evaluated in this study. Long-acting moxidectin at a single dose of 1 mg kg(-1) body weight was administered to an entire flock (n=10) of goats. The individual faecal larval count reduction was applied as an indicator of treatment efficacy. A significant reduction (>98%) in larval counts was observed in all surveyed animals 14 days after drug administration. Moxidectin demonstrated persistent activity in this study; the mean faecal larval count reduction was 99.1% ± 1.8 on day 77 of the treatment. Macroscopic abnormalities and histological changes in the lungs of two infected goats were evident during the post-mortem examination. The pathological consequences of M. capillaris infection were observed even three months after parasite elimination. The results of this study indicate that moxidectin is a highly effective anthelmintic agent for the control of muelleriosis in goats. This drug provides animals with fifteen weeks of protections against M. capillaris reinfection.
Efficacy of orally administered moxidectin against naturally acquired gastrointestinal nematodes in cattle. [2019]Anthelmintic efficacy of moxidectin, an experimental antiparasitic macrocyclic lactone, was evaluated in a group of 15 calves harboring naturally acquired gastrointestinal nematodes. Three groups of 5 calves each served as untreated controls (group 1) or principals that were given moxidectin PO at the rate of 0.2 mg/kg (group 2) or 0.4 mg/kg (group 3) of body weight. Equal numbers of control and treated calves were necropsied for parasite recovery on days 10 (3 control and 3 of each treatment group) and 11 (2 control and 2 of each treatment group) after treatment. Efficacies at both doses were greater than 99.8 and 99.9% against active and inhibited larvae and adults of Ostertagia spp, respectively. The overall mean efficacy of each dose was greater than 99.9%.
Therapeutic and persistent efficacy of moxidectin 1% nonaqueous injectable formulation against natural and experimentally induced lung and gastrointestinal nematodes in cattle. [2019]Four controlled trials were conducted to evaluate the therapeutic and persistent efficacy of a new moxidectin formulation (moxidectin 1% nonaqueous injectable) against nematode parasites in cattle. This injectable moxidectin formulation, given as a single subcutaneous injection at a dose rate of 0.02 ml/kg BW to provide 0.2 mg moxidectin/kg BW, was highly efficacious (>90-100%) against larval and/or adult stages of many species of nematodes in cattle including, Dictyocaulus viviparus, Ostertagia spp., Trichostrongylus axei, Haemonchus placei, Trichostrongylus colubriformis, Cooperia spp., Nematodirus helvetianus, Strongyloides papillosus, Oesophagostomum radiatum and Trichuris spp. This formulation had persistent efficacy of >90% against D. viviparus for at least 6 weeks post-treatment, H. placei and Oe. radiatum for 5 weeks post-treatment, and Ostertagia spp. and T. axei for 2 weeks post-treatment.
Safety of moxidectin in avermectin-sensitive collies. [2019]To evaluate the safety of moxidectin administration at doses of 30, 60, and 90 microg/kg of body weight (10, 20, and 30 times the manufacturer's recommended dose) in avermectin-sensitive Collies.
A randomized, single-ascending-dose, ivermectin-controlled, double-blind study of moxidectin in Onchocerca volvulus infection. [2022]Control of onchocerciasis as a public health problem in Africa relies on annual mass ivermectin distribution. New tools are needed to achieve elimination of infection. This study determined in a small number of Onchocerca volvulus infected individuals whether moxidectin, a veterinary anthelminthic, is safe enough to administer it in a future large study to further characterize moxidectin's safety and efficacy. Effects on the parasite were also assessed.
Relative Bioavailability of Liquid and Tablet Formulations of the Antiparasitic Moxidectin. [2016]The antiparasitic agent moxidectin is under development for the treatment of onchocerciasis. As the first-in-human study of moxidectin used a liquid formulation but other trials used tablets, a study was performed to determine the relative bioavailability of the 2 formulations and to gain more information about the pharmacokinetics of moxidectin. Fifty-eight healthy male participants were randomized to receive open-label moxidectin (10 mg) as a tablet (n = 29) or liquid (n = 29) formulation. The mean ± SD pharmacokinetic parameters observed following administration of the tablet were peak concentration (Cmax) 67.1 ± 27.4 ng/mL, time to peak concentration (tmax) 3.2 ± 1.4 hours, area under the concentration time curve (AUC) 4403 ± 2360 ng·h/mL, apparent volume of distribution 3635 ± 1720 L, oral clearance 2.83 ± 1.25 L/h, and elimination half-life 1032 ± 502 hours. The Cmax and AUC observed following administration of the liquid formulation were 28.6% and 28.8% higher, respectively, and tmax 0.9 hours shorter compared with tablets. No serious adverse events (AEs) were observed. The most commonly reported AEs were headache, infection, diarrhea, asthenia, myalgia, and dizziness during the inpatient phase and flu syndrome, headache, and infection during the 6-month outpatient phase. There was no difference in reporting of these AEs between formulations.
The antiparasitic moxidectin: safety, tolerability, and pharmacokinetics in humans. [2022]A study in healthy male volunteers was completed to evaluate the safety, tolerability, and pharmacokinetics of a single oral dose of the antiparasitic moxidectin (MOX). This drug is registered worldwide as a veterinary antiparasitic agent for use in companion and farm animals. This is the first study of MOX in humans. All subjects were between the ages of 18 and 45 years, with normal cardiac, hematologic, hepatic, and renal function. Doses of MOX studied were 3, 9, 18, and 36 mg in cohorts of 6 subjects each (5:1, MOX:placebo). At the 9-mg and 36-mg doses, two separate cohorts were completed, one in the fasted state and one after the consumption of a high-fat breakfast. For all other cohorts, administration was in the fasted state. Safety and tolerability were assessed by physical examinations, ongoing evaluation of adverse events (AEs), and measurement of laboratory values. Pharmacokinetic (PK) samples were collected just prior to dosing and at various time points until 80 days postdose. Safety assessments from all dose groups studied suggested that MOX was generally safe and well tolerated, with a slightly higher incidence of transient, mild, and moderate central nervous system AEs as the dose increased as compared to placebo. The PKs of MOX were dose proportional within the dose range studied, and the elimination half-life (t1/2 elim) was long (mean: 20.2-35.1 days). At the 9-mg and 36-mg doses, a high-fat breakfast was shown to delay and increase the overall absorption but did not increase maximal concentrations when compared to administration in the fasted state. In summary, the results from this study indicate that MOX is safe and well tolerated in humans between the doses of 3 mg and 36 mg.
[Effects of tobramycin dexamethasone eye ointment for blepharitis: multi-center clinical trial]. [2013]To realize the effectiveness and security of Tobramycin and Dexamethasone Eye Ointment for blepharitis treatment. Design Case control studies. Participants 148 patients be diagnosed as blepharitis including 81 cases as research group and 67 cases as control group.
[Bibrocathol eye ointment is efficacious in blepharitis. Results from a randomized, double-blind, controlled clinical trial]. [2018]Bibrocathol (Noviform) 5% ointment is a frequently used therapy for blepharitis. The study included 197 patients who were randomized to be treated over 2 weeks with bibrocathol or an ointment vehicle, respectively. Slit lamp examinations were performed on day 1 (baseline) and day 14 (end of study) to assess lid edema, lid erythema, debris, and pouting of Meibomian glands; patients rated their subjective complaints. Bibrocathol was superior to the control treatment in improving the sum score of the 5 scales (by 7.0 vs 4.7 points, p
[Clinical analysis of 30 cases of children blepharitis]. [2018]To study the clinical features and treatment of children blepharitis.
Successful treatment of blepharitis with bibrocathol (Posiformin® 2 %). [2021]Bibrocathol is a well-established antiseptic drug for the treatment of acute eyelid diseases like blepharitis. Despite its frequent use in clinical practice, no controlled clinical trial on the efficacy of bibrocathol 2% eye ointment has been performed until now. The aim of the study was to investigate efficacy, safety and tolerability of bibrocathol (Posiformin® 2 %) eye ointment in patients diagnosed with blepharitis.
Efficacy and Safety of OC-01 (Varenicline Solution) Nasal Spray on Signs and Symptoms of Dry Eye Disease: The ONSET-2 Phase 3 Randomized Trial. [2022]To evaluate the efficacy and safety of OC-01 (varenicline solution) nasal spray for treatment of patients with dry eye disease.