Ikervis for DED Due to GVHD Post Allo-HSCT

Singapore Eye Research Institute

Status and phase: Unknown; Phase 4

Conditions: MDS-EB-1; Leukemia (Both ALL and AML)

Treatments: Drug: Cyclosporine Ophthalmic

Study type: Interventional

Funder types: Other

Identifiers

NCT04636918

R1641/38/2019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 13 to 95 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 13 and above
• Able to give informed consent

Exclusion criteria

• Presence of concurrent disease
• Unable to complete the follow up

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

40 participants in 1 patient group

Single arm

Other group

Description:

Ikervis (cyclosporine 0.1%), emulsion, one drop into both eyes, once at night.

Treatment:

Drug: Cyclosporine Ophthalmic