Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT04636918
Status:
UNKNOWN
Last Update Posted:
2020-11-19
First Post:
2020-03-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ikervis for DED Due to GVHD Post Allo-HSCT
Sponsor:
Singapore Eye Research Institute
Organization:
Study Overview
Official Title:
Ikervis for Prophylaxis of Dry Eye Disease Due to Graft vs Host Disease Post Allogeneic Haemtopoietic Stem Cell Transplant
Status:
UNKNOWN
Status Verified Date:
2020-11
Last Known Status:
RECRUITING
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:
Ikervis
Brief Summary:
Dry eye disease (DED) is a common sequelae of graft versus host disease (GVHD) after allogeneic hematopoietic stem cell transplantation (allo-HSCT). Since Ikervis is reported to be a safe and efficacious treatment of DED associated with chronic GVHD, our study would like to study the efficacy of prophlactic Ikervis in preventing ocular GVHD development.
Detailed Description:
This is a prospective single arm interventional study.
The recruitment period will be over 12-18 months to enroll all suitable patients. The total duration of prophylaxis will be for 1 year. After completion of the period of prophylaxis, the patients will be followed up as a non-study patient as clinically indicated.
Forty subjects, undergoing allo-HSCT, will be recruited from the Singapore National Eye Centre upon referral from the Department of Hematology, Singapore General Hospital and followed up at least 5 times over a period of 12 months at the Singapore Eye Research Institute.
The images of the subject eyes will be recorded and stored electronically. These images (corneal fluorescein staining score, Lipiview, meibography, conjunctival redness, tear stability assessment) will be used in the analysis of outcome measures. The Lipiview result is in video format.
The recruitment period will be over 12-18 months to enroll all suitable patients. The total duration of prophylaxis will be for 1 year. After completion of the period of prophylaxis, the patients will be followed up as a non-study patient as clinically indicated.
Forty subjects, undergoing allo-HSCT, will be recruited from the Singapore National Eye Centre upon referral from the Department of Hematology, Singapore General Hospital and followed up at least 5 times over a period of 12 months at the Singapore Eye Research Institute.
The images of the subject eyes will be recorded and stored electronically. These images (corneal fluorescein staining score, Lipiview, meibography, conjunctival redness, tear stability assessment) will be used in the analysis of outcome measures. The Lipiview result is in video format.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: