NCT03287635

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Toyos Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Detailed description

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.)

Conditions

• Dry Eye Disease

Interventions

Type	Name	Description
DRUG	Corticotropin 80Unit/Ml Repository Injection	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.

Timeline

• Start date: 2018-07-01
• Primary completion: 2020-02-01
• Completion: 2020-03-04
• First posted: 2017-09-19
• Last updated: 2021-01-28
• Results posted: 2021-01-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study