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

24 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{1 6 7 8 9}

How 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. ^{10 11 12 13 14}

Eligibility 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.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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 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]

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]

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 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]

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]

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]

References

1. United States 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. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Moxidectin: an oral treatment for human onchocerciasis. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Efficacy and persistent activity of moxidectin against natural Muellerius capillaris infection in goats and pathological consequences of muelleriosis. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Efficacy of orally administered moxidectin against naturally acquired gastrointestinal nematodes in cattle. [2019]

5. Netherlands 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. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Safety of moxidectin in avermectin-sensitive collies. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

A randomized, single-ascending-dose, ivermectin-controlled, double-blind study of moxidectin in Onchocerca volvulus infection. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Relative Bioavailability of Liquid and Tablet Formulations of the Antiparasitic Moxidectin. [2016]

9. England pubmed.ncbi.nlm.nih.gov

The antiparasitic moxidectin: safety, tolerability, and pharmacokinetics in humans. [2022]

10. China pubmed.ncbi.nlm.nih.gov

[Effects of tobramycin dexamethasone eye ointment for blepharitis: multi-center clinical trial]. [2013]

11. Germany pubmed.ncbi.nlm.nih.gov

[Bibrocathol eye ointment is efficacious in blepharitis. Results from a randomized, double-blind, controlled clinical trial]. [2018]

12. China pubmed.ncbi.nlm.nih.gov

[Clinical analysis of 30 cases of children blepharitis]. [2018]

13. Germany pubmed.ncbi.nlm.nih.gov

Successful treatment of blepharitis with bibrocathol (Posiformin® 2 %). [2021]

14. United States 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. [2022]