Clinical Efficacy of H.P. Acthar Gel 80 U/ml to Improve the Signs and Symptoms in Subjects With Dry Eye Disease
Condition: Dry Eye Disease
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Intervention: Corticotropin 80Unit/Ml Repository Injection
Intervention description: 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.
Intervention MeSH terms: Adrenocorticotropic Hormone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Study Title: A Phase 4 Study to Assess the Clinical Efficacy of H.P. Acthar Gel 80 U/ml to
      Improve the Signs and Symptoms in Subjects with Dry Eye Disease
    

Eligibility criteria:

        Inclusion Criteria:

          -  At Visit 1 (Screening) individuals of either gender or race will be eligible for study
             participation if they

               1. Provide written informed consent and HIPAA authorization prior to any study
                  related procedures

               2. Are 18 years of age or older

               3. Are willing and able to follow instructions and can be present for required study
                  visits.

               4. Have documented clinical diagnosis of dry eye disease in one or both eyes.

               5. Have a score of at least 40mm on the ocular discomfort scale

               6. Have at least 5 spk on one or both corneas

               7. Have a grade of 1 or greater in the nasal or temporal areas of one or both eyes.

               8. Have normal lid anatomy.

               9. 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.

              10. 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

               1. Have a known hypersensitivity or contraindication to the investigational product
                  or their components.

               2. Have used any of the following medications within 14 days prior to screening

                  a. Topical or nasal vasoconstrictors

               3. 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.

               4. Subjects must be unwilling to abstain from eyelash growth medications for the
                  duration of the trial.

               5. Subjects must not have had penetrating intraocular surgery, refractive surgery or
                  corneal transplantation, eyelid surgery within 12 weeks prior to Visit 1.

               6. Subjects with a history of herpetic keratitis.

               7. Have serious or severe disease or uncontrolled medical condition that in the
                  judgement of the investigator could confound study assessments or limit
                  compliance.