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Ikervis for DED Due to GVHD Post Allo-HSCT

NCT04636918 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-11-19

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Cyclosporine Ophthalmic

Prospective interventional study (single arm)

Sponsors & Collaborators

  • Singapore Eye Research Institute

    lead OTHER

Principal Investigators

  • Li Lim · Senior Consultant

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
13 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-28
Primary Completion
2022-08-22
Completion
2022-12-30

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04636918 on ClinicalTrials.gov