NCT04636918

Ikervis for DED Due to GVHD Post Allo-HSCT

Ikervis for Prophylaxis of Dry Eye Disease Due to Graft vs Host Disease Post Allogeneic Haemtopoietic Stem Cell Transplant

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Singapore Eye Research Institute · Academic / Other
• Sex: All
• Age: 13 Years – 95 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Leukemia (Both ALL and AML)
• MDS-EB-1

Interventions

Type	Name	Description
DRUG	Cyclosporine Ophthalmic	Prospective interventional study (single arm)

Timeline

• Start date: 2019-11-28
• Primary completion: 2022-08-22
• Completion: 2022-12-30
• First posted: 2020-11-19
• Last updated: 2020-11-19

Locations

1 site across 1 country: Singapore