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

NCT03287635 | Completed Phase 4 Results FDA Drug

• 1 other identifier: MMT-4223
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

• 1. Conjunctival Staining With Lissamine Green

  Change in Conjunctival staining with lissamine green.

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

Secondary Outcomes (1)

• Intraocular Pressure

  12 weeks measuring change from baseline to final

Study Arms (1)

Acthar gel 80 U/ml

EXPERIMENTAL

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

Interventions

Corticotropin 80Unit/Ml Repository Injection 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.

Also known as: H.P. Acthar gel

Acthar gel 80 U/ml

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• In order for subjects to be eligible for the study
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• 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.

Sponsors & Collaborators

• Toyos Clinic: lead
• Mallinckrodt: collaborator

Study Sites (1)

Toyos Clinic

Nashville, Tennessee, 37203, United States

Location

Related Publications (1)

• 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.

  PMID: 35460497 DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Limitations and Caveats

single site, open label study

Results Point of Contact

• Title: Dr.
• Organization: Toyos Clinic

mtoyos@toyosclinic.com

9137064408

Study Officials

• Melissa Toyos, MD

  Toyos Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2017
• First Posted: September 19, 2017
• Study Start: July 1, 2018
• Primary Completion: February 1, 2020
• Study Completion: March 4, 2020
• Last Updated: January 28, 2021
• Results First Posted: January 28, 2021

Record last verified: 2021-01

Locations

US (1)