Using Acthar Gel to treat moderate-severe keratitis in autoimmune patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study involves 20 patients with autoimmune diseases and dry eye, who will receive Acthar Gel via a pre-filled injector for 12 weeks. The study aims to assess the effects of the treatment on ocular pain, corneal nerve function, and overall eye health. Participants will undergo various assessments, including confocal imaging and pain scales, to evaluate the treatment's efficacy. Follow-up will continue for up to three years to monitor long-term outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Subject can read, understand, sign and informed consent.
2. Provision of signed and dated informed consent form and HIPPA authorization.
3. Stated willingness to comply with all study procedures and availability
4. for the duration of the study
5. Male or female aged 18-85 years.
6. Normal eyelid anatomy
7. Patients diagnosed with dry eye for at least 6 months prior to enrollment.
8. Patients with Symptom Bother score at Baseline of 50.6 or greater.
9. Patients with a diagnosis of any autoimmune disease.
10. Patients with one or more corneal neuroma as seen on baseline confocal microscopy.
11. Patients with partial or total relief of corneal pain with one drop of proparacaine over 15 minutes post-instillation.
12. No prior use of Acthar Gel SelfJect or otherwise for any indication.

Exclusion Criteria:

* 1\. Have a known hypersensitivity or contraindication to the investigational product or their components.

  2\. Unwilling to participate in study activities or report for study visits. 3. Current pregnancy or lactation per self-report. Patients who are unwilling to use an effective method of birth control while participating in the study and for four weeks after the last dose of study drug is administered.

  4\. Use of antihistamines, mast cell stabilizers, or prescription eye drops within 24 hours prior to screening and for the study, unless the dose has been stable for 14 days.

  5\. Current use of cenegermin, topical nerve growth factor or platelet rich plasma or use within the past 30 days.

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

  7\. 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.

  8\. Systemic medications known to cause dry eye should not be used including antimuscarinics, antihistamines, vitamin A analogs, antianxiety agents, and others unless stable for at least 30 days.

Where it's running

• Toyos Clinic
  Nashville, Tennessee, United States Recruiting

Study contacts

• Study coordinator: Harley cheney Study Coordinator, Study Coordinator
• Email: hcheney@toyosclinic.com
• Phone: +616153274015

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• ETHY-001 safety and activity in Thyroid Eye Disease (TED)

  This study tests ETHY-001 versus placebo to see if it is safe, tolerable, and shows activity in people with thyroid eye disease.

  Recruiting at 2 sites Phase 1 Ethyreal Bio, Inc. · Orland Park, Illinois and 2 other locations · NCT07885605

• Lacrifill to Help Prevent Post-Curgery Dry Eye After Cataract Surgery

  This study tests Lacrifill to see if it helps prevent dry eye symptoms after unilateral cataract surgery.

  Recruiting at 2 sites Phase 4 Eye Research Associates, LLC · Pittsburg, Kansas and 1 other locations · NCT07796178

• Tear-Fluid Stability Testing with iTrace, BOSA, OPD-Scan III, and IDRA for Dry Eye

  A Phase 4 study tests whether four eye devices can detect tear film stability in adults with normal tear film.

  Recruiting Phase 4 Vance Thompson Vision · Sioux Falls, South Dakota · NCT07790211

• CR-402 treatment for refractory autoimmune disease

  This study tests CRT-402, a CD19-targeted CAR-T therapy, in adults with active, treatment-resistant autoimmune diseases like SLE, systemic sclerosis, and inflammatory myopathy to see if it is safe and capable of helping control disease.

  Recruiting Phase 1/2 Myeloid Therapeutics · Nedlands, Western Australia · NCT07778446

• Music-4-MS: A 12-week music-based program to support thinking skills in people with MS

  A 12-week music-based program is tested to see if it helps cognitive function and mood in people living with multiple sclerosis.

  Recruiting University of Texas at Austin · Austin, Texas · NCT07759115

• OT202 1% eye drops for moderate to severe dry eye

  This phase 3 study tests whether 1% OT202 eye drops help people with moderate to severe dry eye better than a placebo.

  Recruiting Phase 3 Ocumension Therapeutics (Suzhou) Co., Ltd · Bengbu, Anhui and 48 other locations · NCT07740564

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.