Ignite Creation Date:
2024-05-06 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05727878
Status:
RECRUITING
Last Update Posted:
2023-11-07
First Post:
2023-02-06
Brief Title:
Trial to Evaluate Safety and Efficacy of KPI-012 Ophthalmic Solution in Participants With PCED
Sponsor:
Combangio Inc
Organization:
Kala Pharmaceuticals Inc
Study Overview
Official Title:
A Study to Evaluate Safety and Efficacy of KPI-012 Ophthalmic Solution in Participants With Persistent Corneal Epithelial Defect PCED
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CHASE
Brief Summary:
The primary objective of the study is to investigate the safety and efficacy of KPI-012 compared to vehicle in participants who have a documented clinical diagnosis of PCED
Detailed Description:
Approximately 90 participants diagnosed with persistent corneal epithelial defect PCED will be enrolled at multiple US centers in a study to assess the safety and efficacy of KPI-012 a topical mesenchymal stem cell secretome therapy After an initial cohort of at least 2 participants to evaluate the safety of the high strength product participants in the second cohort will be randomized to treatment with either the product or vehicle placebo for 8 weeks The percentage of healing will be compared between groups treated with product and vehicle Total length of study participation will be approximately 34 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None