A Phase 4 interventional study of Corticotropin 80Unit/Ml Repository Injection in Dry Eye Disease, sponsored by Toyos Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-28.
Sponsored by Toyos Clinic · Phase 4, Interventional, and Treatment
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
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.)
At Visit 1 (Screening) individuals of either gender or race will be eligible for study participation if they
Exclusion Criteria:
In order for subjects to be eligible for the study
<!-- -->
Have used any of the following medications within 14 days prior to screening
a. Topical or nasal vasoconstrictors
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.
Also known as: H.P. Acthar gel
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.
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.
1. Conjunctival Staining With Lissamine Green
Change in Conjunctival staining with lissamine green.
Time frame: 12 weeks total. Measure is change from baseline to final,
Intraocular Pressure
goldmann tonometry used by qualified technician with fluorescein staining
Time frame: 12 weeks measuring change from baseline to final
| Milestone | Acthar Gel 80 U/ml |
|---|---|
| Started | 19 |
| Completed | 12 |
| Not completed | 7 |
| Withdrew: Lost to follow-up | 5 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Physician decision | 1 |
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.
| scores on a scale | Acthar Gel 80 U/ml |
|---|---|
| Dry Eye Comfort Questionnaire, SANDE | 44.77 ± 3.13 |
Change in Conjunctival staining with lissamine green.
| staining spots on conjunctiva | Acthar Gel 80 U/ml |
|---|---|
| 1. Conjunctival Staining With Lissamine Green | -173.33 ± 464.59 |
goldmann tonometry used by qualified technician with fluorescein staining
| mm Hg | Acthar Gel 80 U/ml |
|---|---|
| Intraocular Pressure | -1.65 ± 1.4 |
Collected over 12 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Acthar Gel 80 U/ml | 0/19 (0%) | 0/19 (0%) | 1/19 (5.3%) |
| Event | Acthar Gel 80 U/ml |
|---|---|
| hypertensionCardiac disorders | 1/19 |
Patients experience persistent symptomatic dry eye disease despite treatment with traditional therapies.
| Age, Categorical(Participants) | Acthar Gel 80 U/ml |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 15 |
| >=65 years | 4 |
| Age, Continuous(years) | Acthar Gel 80 U/ml |
|---|---|
| Mean | 54 (27 to 74) |
| Sex: Female, Male(Participants) | Acthar Gel 80 U/ml |
|---|---|
| Female | 13 |
| Male | 6 |
| Race (NIH/OMB)(Participants) | Acthar Gel 80 U/ml |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 19 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Acthar Gel 80 U/ml |
|---|---|
| United States | 19 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Undecided
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Toyos Clinic