Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2025-12-24 @ 10:54 PM
NCT ID:
NCT06964269
Brief Summary:
Single-site, open label pilot study of 20 autoimmune patients diagnosed with dry eye demonstrating via the proparacaine challenge some peripheral corneal pain component. At least 16 patients will receive and complete 12 weeks of 80 units of Acthar Gel to be injected subcutaneously twice weekly via Acthar Gel single-dose pre-filled SelfJectTM injector (SelfJect) to assess the effects on subjective sensation of ocular pain, conjunctival and corneal staining, in vivo assessments of corneal nerves as measured by confocal imaging, VAS scales of common neuropathic pain symptoms and comfort of SelfJect will be assessed.
Detailed Description:
The primary objective of the study is to demonstrate the on-label use of Acthar Gel with SelfJect for improvement of symptoms in non-infectious keratitis related to systemic autoimmune disease and the improvement of the appearance and function of corneal nerves as visualized by confocal microscopy and demonstrated by Cochet-Bonnet) and to assess the improvement of common neuropathic corneal pain symptoms caused by dysfunctional nerves due to various autoimmune
inflammatory disease. This study will also follow patients for up to 3 years after 12 weeks of administration of Acthar Gel 80 units twice weekly to assess changes from end of treatment to end of study in visual acuity, corneal and conjunctival staining
Study:
NCT06964269
Study Brief:
Protocol Section:
NCT06964269