Clinical trial · Interventional
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
NCT04636918CI-TRIAL-00048378IkervisunknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia (Both ALL and AML) | Leukemia | ONTOLOGY_EXACT | 0.85 |
| MDS-EB-1 | Myelodysplastic Syndrome with Excess Blasts | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclosporine Ophthalmic | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Single arm
- description
- Ikervis (cyclosporine 0.1%), emulsion, one drop into both eyes, once at night.
- interventionNames
- Drug: Cyclosporine Ophthalmic
Primary outcomes (14)
- measure
- To assess change in basline visual acuity using LogMAR chart with prophylactic Ikervis after 3 to 5 weeks before Haematopoietic Stem Cell Transplant and 3 months, 6 months and 12 months post Haematopoietic Stem Cell Transplant.
- timeFrame
- Baseline, 3 months, 6 months and 1 year post-HSCT follow up
- description
- Visual acuity will be assessed using LogMAR chart at baseline screening and 3, 6, and 12 months post-HSCT after prophylactic Ikervis.
- measure
- To assess change in baseline intraocular pressure using non-contact tonometry with 3 months, 6 months and 12 months post Haematopoietic Stem Cell Transplant.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 13 Years
- Maximum age
- 95 Years
Show eligibility criteria text
Inclusion Criteria: * Age 13 and above * Able to give informed consent Exclusion Criteria: * Presence of concurrent disease * Unable to complete the follow up
References
Publications (1)
- DERIVEDTong L, Lim EWL, Yeo SWJ, Hou A, Linn YC, Ho A, Than H, Quek JKS, Hwang WYK, Lim FLWI, Lim L. Conjunctival T Cell Profile in Allogeneic Hematopoietic Stem Cell Transplant Patients after Instilling Topical Cyclosporine-A 0.1% Cationic Emulsion. Ophthalmol Ther. 2023 Jun;12(3):1547-1567. doi: 10.1007/s40123-023-00686-0. Epub 2023 Mar 1. PMID 36856978