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

Primary Purpose

Dry Eye Disease

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Corticotropin 80Unit/Ml Repository Injection

About this trial

This is an interventional treatment trial for Dry Eye Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Toyos Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Acthar gel 80 U/ml

Arm Description

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.

Outcomes

Primary Outcome Measures

Dry Eye Comfort Questionnaire, SANDE

Subjects will be asked to subjectively rate their eye dryness at Visit 1,2 and 3. Subjects will be instructed to rate eye dryness using the scale below. The total length of the line from "no dryness" to "maximal dryness" is 100 mm. The length of the line between the "no dryness" starting point and the first point at which the subject mark crosses the line will be measured in mm. This assessment is a general assessment of the change of both eyes of dryness measure from baseline to final study visit. The measure of discomfort was for the instantaneous measurement at the time of the specific visit.

1. Conjunctival Staining With Lissamine Green

Change in Conjunctival staining with lissamine green.

Secondary Outcome Measures

Intraocular Pressure

goldmann tonometry used by qualified technician with fluorescein staining

Full Information

NCT ID

NCT03287635

First Posted

August 28, 2017

Last Updated

January 8, 2021

Sponsor

Toyos Clinic

Collaborators

Mallinckrodt

1. Study Identification

Unique Protocol Identification Number

NCT03287635

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Completed

Study Start Date

July 1, 2018 (Actual)

Primary Completion Date

February 1, 2020 (Actual)

Study Completion Date

March 4, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Toyos Clinic

Collaborators

Mallinckrodt

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dry Eye Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Acthar gel 80 U/ml

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Corticotropin 80Unit/Ml Repository Injection

Other Intervention Name(s)

H.P. Acthar gel

Intervention Description

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.

Primary Outcome Measure Information:

Title

Dry Eye Comfort Questionnaire, SANDE

Description

Time Frame

12 weeks total. Measure is change on SANDE scale (0 is no dryness and 100mm is maximal dryness) from baseline to final value. Higher values reflect greater amounts of subjective dryness.

Title

1. Conjunctival Staining With Lissamine Green

Description

Change in Conjunctival staining with lissamine green.

Time Frame

12 weeks total. Measure is change from baseline to final,

Secondary Outcome Measure Information:

Title

Intraocular Pressure

Description

goldmann tonometry used by qualified technician with fluorescein staining

Time Frame

12 weeks measuring change from baseline to final

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: At Visit 1 (Screening) individuals of either gender or race will be eligible for study participation if they Provide written informed consent and HIPAA authorization prior to any study related procedures Are 18 years of age or older Are willing and able to follow instructions and can be present for required study visits. Have documented clinical diagnosis of dry eye disease in one or both eyes. Have a score of at least 40mm on the ocular discomfort scale Have at least 5 spk on one or both corneas Have a grade of 1 or greater in the nasal or temporal areas of one or both eyes. Have normal lid anatomy. 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. 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 Have a known hypersensitivity or contraindication to the investigational product or their components. Have used any of the following medications within 14 days prior to screening a. Topical or nasal vasoconstrictors 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. Subjects must be unwilling to abstain from eyelash growth medications for the duration of the trial. Subjects must not have had penetrating intraocular surgery, refractive surgery or corneal transplantation, eyelid surgery within 12 weeks prior to Visit 1. Subjects with a history of herpetic keratitis. Have serious or severe disease or uncontrolled medical condition that in the judgement of the investigator could confound study assessments or limit compliance.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Melissa Toyos, MD

Organizational Affiliation

Toyos Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Toyos Clinic

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

35460497

Citation

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.

Results Reference

derived

Learn more about this trial

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

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