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 : Recruiting
First Posted : September 19, 2017
Last Update Posted : August 27, 2018
|Condition or disease||Intervention/treatment||Phase|
|Dry Eye Disease||Drug: Corticotropin 80Unit/Ml Repository Injection||Phase 4|
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)|
|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|
|Actual Study Start Date :||July 1, 2018|
|Estimated Primary Completion Date :||May 31, 2019|
|Estimated Study Completion Date :||July 31, 2019|
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
- 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.
- 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.
- intraocular pressure [ Time Frame: 12 weeks ]goldmann tonometry
- assessment of res [ Time Frame: 12 weeks ]reporting safety issues to rib
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
|Contact: Dillon O'Brienemail@example.com|
|Contact: Melissa Toyos, MDfirstname.lastname@example.org|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37203|
|Contact: Melissa Toyos, MD 615-327-4015 email@example.com|
|Contact: Dillon OBrien 6153274015 firstname.lastname@example.org|
|Principal Investigator: Melissa Toyos, MD|