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