Ignite Creation Date:
2025-12-24 @ 10:38 PM
Ignite Modification Date:
2026-01-04 @ 4:13 PM
Study NCT ID:
NCT03287635
Status:
COMPLETED
Last Update Posted:
2021-01-28
First Post:
2017-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Efficacy of H.P. Acthar Gel 80 U/ml to Improve the Signs and Symptoms in Subjects With Dry Eye Disease
Sponsor:
Toyos Clinic
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.)
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: