NCT06348602View on ClinicalTrials.gov

Evaluation of Safety & Efficacy for the Prevention of Ocular GVHD With Ophthalmic Tacrolimus vs Cyclosporine in Allo-HSCT

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

August 1, 2023

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Ocular Graft-versus-host Disease
Interventions
DRUG

Cyclosporine ophthalmic solution 0.1%

Ophthalmic prophylaxis begins once engraftment is documented, with a dose of 1 drop in each eye every 12 hours, continued for a duration of 12 continuous months

DRUG

Tacrolimus ophthalmic ointment 0.03%

Ophthalmic prophylaxis begins once engraftment is documented, with a dose of approximately 1 cm or the necessary amount to cover the lower fornix, every 12 hours, continued for a duration of 12 continuous months

Trial Locations (1)

66640

RECRUITING

Hospital Universitario de la U.A.N.L., Nuevo León

All Listed Sponsors
lead

Hospital Universitario Dr. Jose E. Gonzalez

OTHER