Trial · Interventional

CompletedPhase 4Results postedRegistry data

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

NCTNCT03287635Other idMMT-4223

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 4
Enrollment: 19 participants (actual)
Sponsor: Toyos Clinic · Other
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
United States
Start: 1 Jul 2018
Primary completion: 1 Feb 2020
Completion: 4 Mar 2020
First posted: 19 Sept 2017
Last update posted: 28 Jan 2021
Conditions: Dry Eye Disease

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2018201920202021

Ph 4
Clinical Efficacy of H.P. Acthar Gel 80 U/ml to Improve the Signs and Symptoms in Subjects With Dry Eye Disease
NCT03287635
1 Jul 2018 to 4 Mar 2020

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

Corticotropin 80Unit/Ml Repository InjectionDrug

Arms1

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.

Primary outcomes2

Outcomes the sponsor listed as primary.

Dry Eye Comfort Questionnaire, SANDE
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.
Registry description
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
Time frame · 12 weeks total. Measure is change from baseline to final,
Registry description
Change in Conjunctival staining with lissamine green.

Secondary outcomes(1)

Intraocular Pressure
Time frame · 12 weeks measuring change from baseline to final
Registry description
goldmann tonometry used by qualified technician with fluorescein staining

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 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.

Dry Eye Comfort Questionnaire, SANDE

Group	Value (scores on a scale)	Spread
Acthar Gel 80 U/ml	44.77	3.13

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

1. Conjunctival Staining With Lissamine Green

Group	Value (staining spots on conjunctiva)	Spread
Acthar Gel 80 U/ml	-173.33	464.59

Secondary and other outcome results(1)

Secondary outcomeMean· 12 weeks measuring change from baseline to final

Intraocular Pressure

Group	Value (mm Hg)	Spread
Acthar Gel 80 U/ml	-1.65	1.4

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Acthar Gel 80 U/mlPatients 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. 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.	0 / 19	0 / 19	1 / 19

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

PubMed tag: none · 2022

11 results

Results from a Prospective, Open-Label, Phase 4 Pilot Study of Repository Corticotropin Injection for Moderate and Severe Dry Eye Disease.

Toyos et al. 2022Ophthalmology and therapycited by 6

PMID 35460497PMC9114278DOI 10.1007/s40123-022-00501-2PUB-35460497

Free to read · publisher termsCC BY-NC11 results

Read at source See results (11)

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

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.

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