Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06637527
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-04
Brief Title:
The Study Assessing the Safety and Efficacy of OK-101 Treatment in Subjects with Neuropathic Corneal Pain
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2a Randomized Double-Masked Placebo-Controlled Study Assessing the Safety and Efficacy of OK-101 Treatment in Subjects with Neuropathic Corneal Pain
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study in subjects with Neuropathic Corneal Pain is to evaluate the efficacy and safety of OK-101 005 and 01 as compared to placebo instilled 4 timesday in subjects with neuropathic corneal pain as assessed by visual analogue scale VAS
Detailed Description:
Detailed Description Neuropathic corneal pain NCP is a complex disease affecting the somatosensory nervous system characterized by different underlying etiologies and pathogenesis
OK-101 is a lipid conjugated chemerin peptide antagonist of the ChemR23 G-protein coupled receptor which is typically found on immune cells of the eye responsible for the inflammatory response OK-101 has been shown to produce anti-inflammatory and pain-reducing activities in mouse models of dry eye disease and neuropathic corneal pain and is designed to combat washout through the inclusion of the lipid anchor contained in the candidate drug molecule to enhance the residence time of OK-101 within the ocular environment Our preclinical studies have shown that treatment with OK-101 abolishes corneal pain in a murine model of NCP
OK-101 is a lipid conjugated chemerin peptide antagonist of the ChemR23 G-protein coupled receptor which is typically found on immune cells of the eye responsible for the inflammatory response OK-101 has been shown to produce anti-inflammatory and pain-reducing activities in mouse models of dry eye disease and neuropathic corneal pain and is designed to combat washout through the inclusion of the lipid anchor contained in the candidate drug molecule to enhance the residence time of OK-101 within the ocular environment Our preclinical studies have shown that treatment with OK-101 abolishes corneal pain in a murine model of NCP
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None