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

• Status: Completed
• Trial end date: 2020-03-04
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Toyos Clinic
• Collaborator: Mallinckrodt
• Treatments: Adrenocorticotropic Hormone

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.