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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

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ClinicalTrials.gov Identifier: NCT03287635
Recruitment Status : Not yet recruiting
First Posted : September 19, 2017
Last Update Posted : February 8, 2018
Sponsor:
Collaborator:
Mallinckrodt
Information provided by (Responsible Party):
Toyos Clinic

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

Condition or disease Intervention/treatment Phase
Dry Eye Disease Drug: Corticotropin 80Unit/Ml Repository Injection Phase 4

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.)


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : March 1, 2018
Estimated Primary Completion Date : May 31, 2018
Estimated Study Completion Date : July 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Arm Intervention/treatment
Experimental: 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.
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.
Other Name: H.P. Acthar gel




Primary Outcome Measures :
  1. Dry eye comfort questionnaire, OSDI [ Time Frame: 12 weeks total ]
    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 both eyes.

  2. 1. Conjunctival staining with lissamine green [ Time Frame: 12 weeks total ]
    Liquid fluorescein will be used one drop in each eye. Examinaton will occur after 2 minutes using cobalt filter. Discrete spk will be counted and macropunctate staining will be noted.


Secondary Outcome Measures :
  1. intraocular pressure [ Time Frame: 12 weeks ]
    goldmann tonometry

  2. assessment of res [ Time Frame: 12 weeks ]
    reporting safety issues to rib



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03287635


Contacts
Contact: Dillon O'Brien 615.327.4015 dobrien@toyosclinic.com
Contact: Melissa Toyos, MD 615.327.4015 mtoyos@toyosclinic.com

Locations
United States, Tennessee
Toyos Clinic
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Toyos Clinic
Mallinckrodt
  Study Documents (Full-Text)

Documents provided by Toyos Clinic:
Informed Consent Form  [PDF] August 8, 2017
Study Protocol  [PDF] January 11, 2018


Responsible Party: Toyos Clinic
ClinicalTrials.gov Identifier: NCT03287635     History of Changes
Other Study ID Numbers: MMT-4223
First Posted: September 19, 2017    Key Record Dates
Last Update Posted: February 8, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Signs and Symptoms
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Adrenocorticotropic Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs