Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06452316
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-06-05
Brief Title:
Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 01 in Subjects With Limbal Stem Cell Deficiency
Sponsor:
Claris Biotherapeutics Inc
Organization:
Claris Biotherapeutics Inc
Study Overview
Official Title:
An Open-Label Study to Evaluate the Safety and Efficacy of Two CSB-001 Ophthalmic Solution 01 Dosing Regimens in Subjects With Limbal Stem Cell Deficiency
Status:
RECRUITING
Status Verified Date:
2024-10
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:
None
Brief Summary:
This study will enroll subjects with qualifying limbal stem cell deficiency LSCD All subjects will receive CSB-001 investigational drug in either one or both study eyes The study is comprised of two identical phases Dosing Phase I and II of test article dosing separated by a 31- to 40-day period the Dosing Holiday where no test article is administered Dosing Phase II is followed by an observational noninterventional phase Observation Phase
Detailed Description:
None
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