Moxidectin for Blepharitis

Overseen By David Wirta Principal Investigator, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Eye Research Foundation, Inc.

Disqualifiers: Other eye disease

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests moxidectin, a medication, to determine its effectiveness in reducing Demodex eyelash infestation, often linked to blepharitis, an eye condition causing red, swollen eyelids. The study compares moxidectin to a placebo to assess its effectiveness and safety. Participants with active blepharitis and collarettes (flakes around the eyelashes) might be suitable for this study. As a Phase 4 trial, this research aims to understand how the already FDA-approved treatment benefits more patients.

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 is the safety track record for Moxidectin?

Research has shown that moxidectin is usually safe for people. In a study with 164 adults who had a different infection, moxidectin caused no serious side effects, indicating its safety for treating other conditions. As this trial is in a later stage, earlier studies have already provided extensive safety information. Researchers are also investigating moxidectin for treating blepharitis, a condition affecting the eyelids. While this specific use is still under study, current data suggests that moxidectin is generally safe for people. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for blepharitis, which typically involve antibiotics and anti-inflammatory drugs, Moxidectin offers a novel approach. This drug is unique because it targets parasitic infections, which could be an underlying cause of blepharitis in some cases. Researchers are excited about Moxidectin because it has a different mechanism of action compared to current options, potentially providing relief for patients who don't respond well to traditional therapies. Additionally, Moxidectin's effectiveness in treating similar conditions suggests it might work more rapidly and efficiently for blepharitis.

What evidence suggests that moxidectin might be an effective treatment for blepharitis?

Research has shown that moxidectin is under study as a potential treatment for blepharitis, often caused by tiny mites called Demodex on the eyelashes. Although past studies on blepharitis have had low success rates, researchers believe moxidectin may help by targeting these mites that cause irritation. While clinical data on moxidectin's effectiveness for blepharitis remains limited, early treatments for Demodex infestations have shown positive results, suggesting it could be promising. This trial aims to further investigate moxidectin's ability to reduce eyelash infestation and improve symptoms. Participants will receive either moxidectin or a placebo to assess its effectiveness. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Moxidectin tablets or placebo for the reduction of Demodex eyelash infestation

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Moxidectin

Trial Overview 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.

How Is the Trial Designed?

Group I: Active and Placebo Experimental Treatment 2 Interventions

Group II: Active Active Control 1 Intervention

Group III: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Eye Research Foundation, Inc.

Lead Sponsor

Trials

1

Recruited

20+

Published Research Related to This Trial

Moxidectin, administered as a single dose of 1 mg/kg to a flock of 10 goats, resulted in over 98% reduction in faecal larval counts of Muellerius capillaris 14 days post-treatment, demonstrating its high efficacy as an anthelmintic agent.

The treatment provided persistent protection against reinfection for up to 15 weeks, although some pathological changes in the lungs were still observed three months after the parasites were eliminated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and persistent activity of moxidectin against natural Muellerius capillaris infection in goats and pathological consequences of muelleriosis. Vadlejch, J., Makovický, P., Čadková, Z., et al.[2019]

Moxidectin, an experimental antiparasitic drug, demonstrated over 99.9% efficacy in treating gastrointestinal nematodes in a study involving 15 calves, indicating its strong effectiveness against these parasites.

Both doses of moxidectin (0.2 mg/kg and 0.4 mg/kg) were highly effective, with no significant difference in efficacy, suggesting that even the lower dose is sufficient for effective treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of orally administered moxidectin against naturally acquired gastrointestinal nematodes in cattle. Zimmerman, GL., Hoberg, EP., Pankavich, JA.[2019]

Tobramycin and Dexamethasone Eye Ointment significantly improved symptoms and signs of blepharitis in 148 patients over a 28-day treatment period, with notable improvements observed at 7, 14, and 28 days.

While the ointment was effective, there was a small risk of elevated intraocular pressure, with 3.7% of patients in the treatment group experiencing this side effect, highlighting the need for monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effects of tobramycin dexamethasone eye ointment for blepharitis: multi-center clinical trial]. Yan, XM., Sun, XG., Xie, HP., et al.[2013]

In a study of 197 patients, bibrocathol (5% ointment) significantly improved symptoms of blepharitis compared to a control treatment, with a greater reduction in symptoms observed in those with severe cases.

The treatment was well tolerated and safe, demonstrating efficacy as an antiseptic therapy for acute blepharitis that does not require antibiotics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Bibrocathol eye ointment is efficacious in blepharitis. Results from a randomized, double-blind, controlled clinical trial]. Behrens-Baumann, W., Niederdellmann, C., Jehkul, A., et al.[2018]

In a phase 3 study involving 758 adults with dry eye disease, OC-01 nasal spray significantly improved tear production compared to a placebo, with 47.3% and 49.2% of patients in the OC-01 treatment groups achieving a 10-mm improvement in Schirmer test scores at week 4.

OC-01 was well tolerated, with most treatment-emergent adverse events being mild and nonocular, although a higher percentage of patients in the OC-01 groups reported side effects compared to the vehicle group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Wirta, D., Vollmer, P., Paauw, J., et al.[2022]

In a study involving 164 adults with Wuchereria bancrofti infection, moxidectin was found to be well tolerated, with no serious adverse events reported and similar safety profiles compared to ivermectin.

Both moxidectin and ivermectin treatment regimens resulted in mild to moderate treatment-emergent adverse events, but there were no significant differences in the frequency or severity of these events between the different treatment groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of moxidectin and ivermectin combination treatments for lymphatic filariasis in Côte d'Ivoire: A randomized controlled superiority study. Bjerum, CM., Koudou, BG., Ouattara, AF., et al.[2023]

In a study involving 132 participants in Ghana, the 8 mg dose of moxidectin was found to be safe for use, with manageable side effects that resolved without treatment, making it suitable for further large-scale studies.

Moxidectin demonstrated a significantly greater reduction in Onchocerca volvulus microfilariae compared to ivermectin, suggesting it may be more effective in controlling onchocerciasis and aiding in elimination efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, single-ascending-dose, ivermectin-controlled, double-blind study of moxidectin in Onchocerca volvulus infection. Awadzi, K., Opoku, NO., Attah, SK., et al.[2022]

Moxidectin has been shown to provide stronger and longer suppression of microfilariae compared to ivermectin in phase II and III clinical trials, indicating its potential as a more effective treatment for onchocerciasis.

If moxidectin is donated for use, it could significantly reduce the costs associated with biannual ivermectin distribution, while utilizing existing treatment infrastructures, making it a practical option for onchocerciasis elimination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Moxidectin: an oral treatment for human onchocerciasis. Milton, P., Hamley, JID., Walker, M., et al.[2021]

In a study involving 24 avermectin-sensitive Collies, moxidectin was administered at doses up to 90 microg/kg (30 times the recommended dose) without any signs of toxicosis observed in the dogs.

The results suggest that moxidectin has a wider safety margin compared to ivermectin and milbemycin for this breed, indicating it may be a safer alternative for treating conditions in avermectin-sensitive dogs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of moxidectin in avermectin-sensitive collies. Paul, AJ., Tranquilli, WJ., Hutchens, DE.[2019]

In a study involving 197 patients with blepharitis, bibrocathol 2% eye ointment demonstrated significant efficacy in improving symptoms compared to a placebo, with a strong effect size (Cohen's d = 0.73).

The treatment was well-tolerated, with no safety concerns regarding intraocular pressure or visual acuity, indicating that bibrocathol is a safe option for managing blepharitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful treatment of blepharitis with bibrocathol (Posiformin® 2 %). Bezdetko, PA., Sergienko, N., Dyomin, Y., et al.[2021]

The new moxidectin 1% nonaqueous injectable formulation demonstrated over 90-100% efficacy against various nematode parasites in cattle, including species like Dictyocaulus viviparus and Haemonchus placei, after a single subcutaneous injection.

This formulation also showed persistent efficacy, maintaining over 90% effectiveness against D. viviparus for at least 6 weeks and for 5 weeks against H. placei, indicating its long-lasting protective effects in cattle.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic and persistent efficacy of moxidectin 1% nonaqueous injectable formulation against natural and experimentally induced lung and gastrointestinal nematodes in cattle. Ranjan, S., DeLay, R.[2019]

In a study involving 58 healthy male participants, the liquid formulation of moxidectin showed higher peak concentration and area under the curve compared to the tablet formulation, indicating better bioavailability.

No serious adverse events were reported for either formulation, and the most common side effects were mild, such as headache and infection, suggesting that moxidectin is safe for use in humans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relative Bioavailability of Liquid and Tablet Formulations of the Antiparasitic Moxidectin. Korth-Bradley, JM., Parks, V., Patat, A., et al.[2016]

Moxidectin (MOX) was found to be generally safe and well tolerated in healthy male volunteers, with mild to moderate central nervous system side effects occurring more frequently at higher doses, but overall safety was confirmed across doses of 3 mg to 36 mg.

The pharmacokinetics of MOX showed that its absorption is dose proportional and has a long elimination half-life of 20.2 to 35.1 days, with food intake affecting absorption rates but not peak concentrations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The antiparasitic moxidectin: safety, tolerability, and pharmacokinetics in humans. Cotreau, MM., Warren, S., Ryan, JL., et al.[2022]

In a study of 30 children with blepharitis, 50% were also diagnosed with keratitis, primarily viral, indicating a significant association between blepharitis and corneal complications.

The overall cure rate for blepharitis in these children was low, with only 16.7% fully cured, highlighting the need for effective treatment strategies and patient compliance for better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical analysis of 30 cases of children blepharitis]. Jiang, C., Wang, ZQ., Zhang, Y., et al.[2018]

Citations

1. withpower.com withpower.com/trial/moxidectin-for-blepharitis-3df72

Moxidectin for Blepharitis · Info for Participants The overall cure rate for blepharitis in these children was low, with only 16.7% fully cured, highlighting the need for effective treatment strategies and ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31229586/

Efficacy of treatments for Demodex blepharitis The overall effect sizes for efficiency of all treatments, globally, were 1.68 (95CI 1.25 to 2.12), 0.45 (0.26-0.64), and 0.76 (0.59-0.90), respectively. Except ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/condition/1051/blepharitis

Blepharitis Clinical Research Trials Although they may require repeated applications, low concentration solutions (0.1-1%) were proven to be safer and effective and are widely utilized in some ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1542012419300655

Efficacy of treatments for Demodex blepharitis We reported the efficiency of the different treatments of Demodex blepharitis. Because of less systemic side effects, local treatments seem promising molecules.

5. jmcp.org jmcp.org/doi/10.18553/jmcp.2024.30.10-a.s1

Multidisciplinary perspectives in Demodex blepharitis With a 6-week course of lotilaner ophthalmic solution 0.25%, Demodex blepharitis can be successfully treated with lasting benefit. Because ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10878406/

A Systematic Review and Meta-Analysis of the Safety ... Twice-daily treatment with Lotilaner ophthalmic solution 0.25% for six weeks generally was safe and well tolerated and met the primary endpoint ...