Repository Corticotropin Injection in Keratoconjunctivitis Sicca

Status Withdrawn

Clinical Trial Summary

The purpose of this pilot study is to assess repository corticotropin injection (RCI) in the form of H.P. Acthar Gel in patients with severe keratoconjunctivitis sicca (KCS, or dry eye disease). This pilot study is a non-randomized, open-label, interventional study to assess the efficacy and timeline of RCI for the treatment of severe KCS recalcitrant to conventional therapy. The purpose is to acquire preliminary data to support and guide the design of a future, double-masked, randomized, controlled clinical trial.

Clinical Trial Description

This study is a non-randomized, open-label, interventional pilot study with sixteen weeks (112 days) of active treatment, a possible twelve-week treatment extension, and twenty-four weeks of washout follow-up. Intervention is with HP Acthar Gel dosed at 80 U BIW SC indicated for use in anterior segment disease and keratitis. Data will be collected from five subjects. All subjects will be treated with 80 U BIW SC and clinically examined at two, four, six, nine, twelve, and sixteen weeks with a potential extension of up to twenty-eight weeks. Extension will be contingent upon specific outcome criteria defined in this protocol. Four clinical visits will occur at two, four, eight, and twelve weeks after initiating the drug taper to assess for regression of the signs and symptoms of KCS. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03398018
Study type	Interventional
Source	University of Alabama at Birmingham
Contact
Status	Withdrawn
Phase	Phase 4
Start date	November 1, 2018
Completion date	November 1, 2018

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT05618730` - Safety, Tolerability, Plug Retention and Preliminary Efficacy of Tacrolimus-loaded Punctal Plug in Patients With Moderate to Severe Dry Eye Disease - Cohort B	Phase 1
Completed	`NCT02254265` - Phase 2/3 Dose-Ranging Study of the Safety and Efficacy of OTX-101 in the Treatment of Keratoconjunctivitis Sicca	Phase 2/Phase 3
Completed	`NCT00883649` - Efficacy and Safety Study of Nutritional Supplements for Treatments of Dry Eye	N/A
Completed	`NCT00128245` - Safety and Efficacy of Pimecrolimus Ophthalmic Suspension in Patients With Moderate to Severe Keratoconjunctivitis Sicca	Phase 2
Completed	`NCT00717418` - Efficacy Study of Cyclosporine Ophthalmic Emulsion in Patients With Dry Eye Disease	N/A
Enrolling by invitation	`NCT03436576` - Efficacy of Two Concentrations of Autologous Serum for the Treatment of Severe Dry Eye	Phase 3
Completed	`NCT04147650` - Dose Ranging Study to Assess the Efficacy and Safety of Voclosporin Ophthalmic Solution in Subjects With Dry Eye Syndrome	Phase 2/Phase 3
Completed	`NCT01733992` - A Safety, Tolerability and Pharmacokinetics Study of R932348 Eye Drops in Patients With Dry Eye Disease	Phase 1
Completed	`NCT00987727` - Safety and Efficacy of Carboxymethylcellulose for Ocular Surface Integrity in Symptomatic Dry Eye	Phase 4
Completed	`NCT00788229` - Efficacy and Safety Study of ATs in Patients With Dry Eye Syndrome	Phase 2
Completed	`NCT00554879` - Acupuncture Treatment of Dry Eye	N/A
Completed	`NCT00407043` - Multicenter, Randomized, Controlled Study of the Effect of Lotemax on Initiation of Dry Eye Treatment With Restasis	Phase 4
Completed	`NCT00001731` - Treatment of Dry Eye Syndrome With Cyclosporin A Eye Drops	Phase 2
Recruiting	`NCT03953703` - Levocarnitine for Dry Eye in Sjogren's Syndrome	Phase 2
Recruiting	`NCT02066896` - Laser Therapy to Treat the Dry Mouth of Sjogren's Syndrome	Phase 3
Completed	`NCT02139033` - A Phase 4 Study Investigating the Efficacy of Retaine™ in Managing Signs and Symptoms Associated With Dry Eye Syndrome	Phase 4
Terminated	`NCT01213342` - Omega-3 Fatty Acid Supplements and Dry Eye	N/A
Completed	`NCT00201981` - Study of Rebamipide Eye Drops to Treat Dry Eye	Phase 3
Completed	`NCT00201955` - Study of Rebamipide Eye Drops to Treat Dry Eye	Phase 3
Completed	`NCT00025818` - Six Month Clinical Research Study for Patients With Moderate or Severe Dry Eye Syndrome	Phase 3