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

NCT ID: NCT03287635

Last Updated: 2021-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-01
• Study Completion Date: 2020-03-04

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Acthar gel 80 U/ml

Patients who continue to experience clinically significant symptoms of dry eye disease even after utilizing traditional methods of treatment for dry eye including but not limited to artificial tears, warm compresses, topical anti-inflammatories like cyclosporine and/or lifitegrast. Patients will receive repository corticotropin intramuscular injections 80 u/ml 2-3 times weekly for up to 3 months as judged by the investigator.

Group Type: EXPERIMENTAL

Corticotropin 80Unit/Ml Repository Injection

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

H.P. Acthar gel

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mallinckrodt

INDUSTRY

Sponsor Role: collaborator

Toyos Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Melissa Toyos, MD

Role: PRINCIPAL_INVESTIGATOR

Toyos Clinic

Locations

Toyos Clinic

Nashville, Tennessee, United States

Countries

United States

References

Toyos M, Toyos R, Jodoin B, Bunch R. Results from a Prospective, Open-Label, Phase 4 Pilot Study of Repository Corticotropin Injection for Moderate and Severe Dry Eye Disease. Ophthalmol Ther. 2022 Jun;11(3):1231-1240. doi: 10.1007/s40123-022-00501-2. Epub 2022 Apr 23.

Reference Type: DERIVED

PMID: 35460497 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

MMT-4223

Identifier Type: -

Identifier Source: org_study_id