Intervention: Acthargel
Trial phase: Phase 4
SMILES: CSCCC(NC(=O)C(CO)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(N)CO)C(=O)NC(CCC(=O)O)C(=O)NC(Cc1cnc[nH]1)C(=O)NC(Cc1ccccc1)C(=O)NC(CCCNC(=N)N)C(=O)NC(Cc1c[nH]c2ccccc12)C(=O)NCC(=O)NC(CCCCN)C(=O)N1CCCC1C(=O)NC(C(=O)NCC(=O)NC(CCCCN)C(=O)NC(CCCCN)C(=O)NC(CCCNC(=N)N)C(=O)NC(CCCNC(=N)N)C(=O)N1CCCC1C(=O)NC(C(=O)NC(CCCCN)C(=O)NC(C(=O)NC(Cc1ccc(O)cc1)C(=O)N1CCCC1C(=O)NC(CC(N)=O)C(=O)NCC(=O)NC(C)C(=O)NC(CCC(=O)O)C(=O)NC(CC(=O)O)C(=O)NC(CCC(=O)O)C(=O)NC(CO)C(=O)NC(C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(Cc1ccccc1)C(=O)N1CCCC1C(=O)NC(CC(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(Cc1ccccc1)C(=O)O)C(C)C)C(C)C)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 19
Group description: Patients who continue to experience clinically significant symptoms of dry eye disease even after utilizing traditional methods of treatment for dry eye including but not limited to artificial tears, warm compresses, topical anti-inflammatories like cyclosporine and/or lifitegrast. Patients will receive repository corticotropin intramuscular injections 80 u/ml 2-3 times weekly for up to 3 months as judged by the investigator.

Corticotropin 80Unit/Ml Repository Injection: H.P. Acthar Gel (repository corticotropin injection) is an adrenocorticotropic hormone (ACTH) analogue used for: Treatment during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus.
Eligibility criteria:
Inclusion Criteria:

At Visit 1 (Screening) individuals of either gender or race will be eligible for study participation if they

Provide written informed consent and HIPAA authorization prior to any study related procedures
Are 18 years of age or older
Are willing and able to follow instructions and can be present for required study visits.
Have documented clinical diagnosis of dry eye disease in one or both eyes.
Have a score of at least 40mm on the ocular discomfort scale
Have at least 5 spk on one or both corneas
Have a grade of 1 or greater in the nasal or temporal areas of one or both eyes.
Have normal lid anatomy.
Are women of child bearing potential who are not pregnant or lactating and who are either abstinent and willing to remain so for the course of the trial or have an IUD in place for at least 3 months prior and through Visit 4, barrier method with spermicide for at least 3 months prior and through Visit 4, stable hormonal contraceptive for at least 3 months prior and through Visit 4 or in a monogamous relationship with a surgically sterilized (vasectomized) partner at least 6 months prior to Visit 1 and through the course of the trial.

Are postmenopausal (no menstrual cycle for at least one year prior to Visit 1) or have undergone bilateral tubal ligation, hysterectomy, hysterectomy with uni or bilateral oophorectomy, or bilateral oophorectomy.

Exclusion Criteria:

In order for subjects to be eligible for the study

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

Have used any of the following medications within 14 days prior to screening

a. Topical or nasal vasoconstrictors

Subjects can be on the following medications if they have been on a stable dose for 12 weeks topical cyclosporine, topical lifitegrast and/or topical loteprednol etabonate. Tetracycline compounds, omega 3s, anticholinergics, anticonvulsants, antidepressants, retinoids, systemic immunosuppressive agents including oral corticosteroids, non-steroidals, antihistamines or mast cell stabilizers, punctal plugs, contact lens wear and glaucoma medications.
Subjects must be unwilling to abstain from eyelash growth medications for the duration of the trial.
Subjects must not have had penetrating intraocular surgery, refractive surgery or corneal transplantation, eyelid surgery within 12 weeks prior to Visit 1.
Subjects with a history of herpetic keratitis.
Have serious or severe disease or uncontrolled medical condition that in the judgement of the investigator could confound study assessments or limit compliance.