Phase
Condition
Eye Disorders/infections
Connective Tissue Diseases
Collagen Vascular Diseases
Treatment
Acthar Gel 80 UNT/ML Injectable Solution
Clinical Study ID
Ages 18-85 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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
Male or female aged 18-85 years.
Normal eyelid anatomy
Patients diagnosed with dry eye for at least 6 months prior to enrollment.
Patients with Symptom Bother score at Baseline of 50.6 or greater.
Patients with a diagnosis of any autoimmune disease.
Patients with one or more corneal neuroma as seen on baseline confocal microscopy.
Patients with partial or total relief of corneal pain with one drop of proparacaineover 15 minutes post-instillation.
No prior use of Acthar Gel SelfJect or otherwise for any indication.
Exclusion
Exclusion Criteria:
Have a known hypersensitivity or contraindication to the investigationalproduct or their components.
Unwilling to participate in study activities or report for study visits. 3.Current pregnancy or lactation per self-report. Patients who are unwilling touse an effective method of birth control while participating in the study andfor four weeks after the last dose of study drug is administered.
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 stablefor 14 days.
Current use of cenegermin, topical nerve growth factor or platelet rich plasmaor use within the past 30 days.
Treatment with another investigational drug or other intervention within 30days of screening.
Have serious or severe disease or uncontrolled medical condition that in thejudgement of the investigator could confound study assessments, limitcompliance, or pose safety risks.
Systemic medications known to cause dry eye should not be used includingantimuscarinics, antihistamines, vitamin A analogs, antianxiety agents, andothers unless stable for at least 30 days.
Study Design
Study Description
Connect with a study center
Toyos Clinic
Nashville, Tennessee 37215
United StatesActive - Recruiting

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