Acthar Gel for Dry Eye Syndrome

(MNK Trial)

Overseen By Melissa Toyos, MD, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Toyos Clinic

Must not be taking: Antihistamines, Mast cell stabilizers

Disqualifiers: Pregnancy, Lactation, Serious disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

20 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop using antihistamines, mast cell stabilizers, or prescription eye drops 24 hours before screening and during the study unless the dose has been stable for 14 days. Also, you should not use systemic medications known to cause dry eye unless they have been stable for at least 30 days.

What data supports the effectiveness of the drug Acthar Gel for treating dry eye syndrome?

The study on repository corticotropin injection (Acthar Gel) for dry eye disease suggests it may help patients who haven't responded to other treatments, indicating potential effectiveness for this condition. ^{1 2 3 4 5}

What is the purpose of this trial?

Single-site, open label pilot study of 20 autoimmune patients diagnosed with dry eye demonstrating via the proparacaine challenge some peripheral corneal pain component. At least 16 patients will receive and complete 12 weeks of 80 units of Acthar Gel to be injected subcutaneously twice weekly via Acthar Gel single-dose pre-filled SelfJectTM injector (SelfJect) to assess the effects on subjective sensation of ocular pain, conjunctival and corneal staining, in vivo assessments of corneal nerves as measured by confocal imaging, VAS scales of common neuropathic pain symptoms and comfort of SelfJect will be assessed.

Eligibility Criteria

This trial is for autoimmune patients with moderate to severe keratitis, specifically those who experience corneal pain. Participants must have dry eye syndrome and show a response to the proparacaine challenge indicating peripheral corneal pain.

Inclusion Criteria

Subject can read, understand, sign and informed consent

Provision of signed and dated informed consent form and HIPPA authorization

Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria

Treatment with another investigational drug or other intervention within 30 days of screening

Have serious or severe disease or uncontrolled medical condition that in the judgement of the investigator could confound study assessments, limit compliance, or pose safety risks

Unwilling to participate in study activities or report for study visits

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 80 units of Acthar Gel injected subcutaneously twice weekly for 12 weeks using the SelfJectTM injector

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of visual acuity, corneal and conjunctival staining

3 years

Treatment Details

Interventions

• Acthar Gel

Trial Overview The study tests Acthar Gel (80 units) injected subcutaneously twice weekly using a pre-filled SelfJect injector. The focus is on reducing ocular pain, improving corneal health, and evaluating patient comfort with the SelfJect system over 12 weeks.

Participant Groups

Group I: One study arm of approximately 20 active receiving and completing active, open-label interventions. Active Control 1 Intervention

One study arm of approximately 20 active receiving and completing active, open-label interventions.

Who Is Running the Clinical Trial?

Toyos Clinic

Lead Sponsor

Trials

9

Recruited

260+

References

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

Lubricant with gelling agent in treating dry eye in adult Chinese patients. [2022]

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

The impact of dry eye disease treatment on patient satisfaction and quality of life: A review. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Efficacy of a novel moist cool air device in office workers with dry eye disease. [2013]

4. England pubmed.ncbi.nlm.nih.gov

Results from a Prospective, Open-Label, Phase 4 Pilot Study of Repository Corticotropin Injection for Moderate and Severe Dry Eye Disease. [2023]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Patient satisfaction with glaucoma therapy: reality or myth? [2022]