Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2025-12-24 @ 10:54 PM
NCT ID:
NCT06964269
Eligibility Criteria:
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT06964269
Study Brief:
Protocol Section:
NCT06964269