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

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.