Repository Corticotropin Injection in Keratoconjunctivitis Sicca
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ClinicalTrials.gov Identifier: NCT03398018 |
Recruitment Status :
Withdrawn
(Change of direction)
First Posted : January 12, 2018
Last Update Posted : December 14, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Keratoconjunctivitis Sicca | Drug: repository corticotropin injection | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Efficacy of Repository Corticotropin Injection in Patients With Severe and Recalcitrant Keratoconjunctivitis Sicca |
Actual Study Start Date : | November 1, 2018 |
Actual Primary Completion Date : | November 1, 2018 |
Actual Study Completion Date : | November 1, 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: Treatment
Treated with repository corticotropin injection
|
Drug: repository corticotropin injection
80 units twice per week as a subcutaneous injection
Other Name: HP Acthar Gel |
- Conjunctival hyperemia [ Time Frame: 16 weeks ]Change from baseline in bulbar conjunctival hyperemia as measured by the Oculus Keratograph 5M
- Corneal staining [ Time Frame: 16 weeks ]Change from baseline in corneal staining with fluorescein
- Patient symptoms [ Time Frame: 16 weeks ]Change from baseline in patient symptoms as measured by Ocular Surface Disease Index (OSDI)
- Tear cytokine concentration [ Time Frame: 16 weeks ]Change from baseline in tear cytokine concentration as measured by Raybiotech Human Dry Eye Disease Array Q1
- Needle Fear [ Time Frame: 16 weeks ]Change from baseline in Needle Fear Survey

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age ≥ 18 years
- Severe keratoconjunctivitis sicca (KCS) as defined by meeting at least three of the following in the same or both eye(s): (1) OSDI ≥ 33, (2) sum corneal staining with fluorescein of ≥ 5 in at least one eye, (3) MMP-9 concentration ≥ 40 ng/ml in at least one eye as measured by InflammaDry®, and (4) bulbar hyperemia of ≥ 2.0 in at least one eye as measured by the Oculus Keratograph® 5M
- Recalcitrant or intolerant to treatment with cyclosporine 0.05% ophthalmic emulsion (Restasis®) or lifitegrast 5% ophthalmic solution (Xiidra®)
Exclusion Criteria:
- Past or present history of: scleroderma, osteoporosis, systemic bacterial or fungal infection (including but not limited to tuberculosis), psychosis, ocular herpes simplex, peptic ulcer, congestive heart failure, diabetes mellitus, myasthenia gravis, hypothyroidism, liver cirrhosis, primary adrenocortical insufficiency or adrenocortical hyperfunction, central serous chorioretinopathy.
- Any corticosteroid use within 60 days of study enrollment
- Topical cyclosporine 0.05% ophthalmic emulsion (Restasis) or lifitegrast 5% ophthalmic solution (Xiidra) use within 60 days of study enrollment
- Recent surgery within 90 days
- Current uncontrolled, sustained hypertension
- Post-prandial blood glucose value of ≥ 140 mg/dl as measured at the baseline visit
- Sensitivity to proteins of porcine origin
- Anticipated administration of live or live attenuated vaccines during the course of the study
- Known sensitivity to steroid or complications from prior steroid use that subject is unwilling to tolerate
- Pregnancy (as assessed by urine hCG) or nursing
- Participation in a clinical trial involving a drug or device within the past 30 days
- Investigator discretion based upon medical history and/or opinion of ability to maintain protocol compliance

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): NCT03398018
United States, Alabama | |
University of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35294 |
Principal Investigator: | Jason J Nichols, OD, MPH, PhD | University of Alabama at Birmingham |
Responsible Party: | Jason Nichols, Principal Investigator, University of Alabama at Birmingham |
ClinicalTrials.gov Identifier: | NCT03398018 |
Other Study ID Numbers: |
F00000001 |
First Posted: | January 12, 2018 Key Record Dates |
Last Update Posted: | December 14, 2018 |
Last Verified: | December 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
dry eye corticotropin |
Keratoconjunctivitis Keratoconjunctivitis Sicca Dry Eye Syndromes Conjunctivitis Conjunctival Diseases Eye Diseases Keratitis |
Corneal Diseases Lacrimal Apparatus Diseases Adrenocorticotropic Hormone Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |