Clinical Efficacy of H.P. Acthar Gel 80 U/ml to Improve the Signs and Symptoms in Subjects With Dry Eye Disease

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

Objectives: The primary objective of this study is to investigate the safety and efficacy of H.P. Acthar Gel 80 U/ml in subjects with a documented clinical diagnosis of dry eye disease.

Study Population: The study population will consist of subjects diagnosed with dry eye disease.

Number of Subjects: Approximately 12 subjects

Investigational Product: H.P. Acthar Gel 80 U/ml sufficient for the duration of the study will be supplied by Mallinkrodt to the enrolled subjects

Route and Duration of Administration: Product will be injected subcutaneously weekly by subjects for approximately 12 weeks.

Study Design: This is a Phase 4, single center single arm study designed to evaluate the safety and efficacy of H.P. Achthar Gel in subjects with dry eye disease.

Approximately 25 subjects will be screened and 12 subjects enrolled at one center in the United States.

Subjects will be given 80 international units of study medication subcutaneously depending on the severity of the disease as determined by the primary investigator.

The study will include 3 study visits over 12 weeks. At Visit 1 Screening (14 +/- 1 days prior to Day 1), subjects meeting inclusion/exclusion criteria will begin investigational drug use. Subjects will return for evaluations at Visit 2 (Day 42+/-3 days) and Visit 3 (Day 84 +/-5 days). Subjects will be released from the study at the end of Visit 3 (Day 84+/- 5 days.)

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

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  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.