nctId: NCT06348602 id: PI23-00201 briefTitle: Evaluation of Safety & Efficacy for the Prevention of Ocular GVHD With Ophthalmic Tacrolimus vs Cyclosporine in Allo-HSCT overallStatus: RECRUITING date: 2023-08-01 date: 2025-12-31 date: 2025-12-31 date: 2024-04-04 date: 2024-04-08 name: Hospital Universitario Dr. Jose E. Gonzalez class: OTHER briefSummary: Chronic GVHD (cGVHD) is a predominant cause of mortality and disability not related to relapse; it occurs in 30 to 70% of patients. The majority of patients with cGVHD present with ocular involvement with a reported incidence of 40-60%. Symptoms can range from mild dry eye syndrome to severe epithelial defects that can generate corneal perforation and loss of vision. The most accepted pharmacological modality is the topical application of cyclosporine A; on the other hand, tacrolimus has shown greater immunosuppressive power when used in ocular GVHD. However, this effectiveness is limited since by the time the manifestations appear, there is already permanent damage to the lacrimal gland due to the lymphocytic infiltration; so it is necessary to use a prevention strategy before these manifestations appear. Previously, the employment of ocular cyclosporine drops as ocular GVHD prophylaxis was assessed to evaluate safety and effectiveness, showing that it is well tolerated and can limit the appearance of severe dry eye manifestations in a small group of patients. The purpose of this work is to compare the two modalities currently accepted for the treatment of the disease, but in a prophylactic way; topical ciclosporin A against topical tacrolimus, to determine the safety and efficiency of each of them as a preventive measure to limit the risk of developing the appearance of ocular cGVHD and the permanent consequences that this generates. conditions: Ocular Graft-versus-host Disease studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Experimental, prospective, randomized, unblinded. primaryPurpose: PREVENTION masking: NONE count: 60 type: ESTIMATED name: Cyclosporine ophthalmic solution 0.1% name: Tacrolimus ophthalmic ointment 0.03% measure: Incidence of ocular graft-versus-host disease in patients undergoing allo-HSCT receiving topical prophylaxis with Cyclosporine A or Tacrolimus as assessed by the International Consensus Criteria on chronic ocular graft-versus-host disease. measure: Incidence of ocular graft-versus-host disease in patients undergoing allo-HSCT receiving topical prophylaxis with Cyclosporine A or Tacrolimus as assessed by the National Institutes of Health Consensus Development Projects on Chronic GVHD scoring system. measure: Prevalence of ocular GVHD based on historical records in the hematology service of the University Hospital U.A.N.L. in patients without prophylactic treatment as assessed by the International Consensus Criteria on chronic ocular graft-versus-host disease measure: Severity of ocular GVHD based on historical records in the hematology service of the University Hospital U.A.N.L. in patients without prophylactic treatment, as assessed by the International Consensus Criteria on chronic ocular graft-versus-host disease. measure: Prevalence of ocular GVHD based on historical records in the hematology service of the University Hospital U.A.N.L. in patients without prophylactic treatment, as assessed by the National Institutes of Health Consensus on Chronic GVHD scoring system. measure: Severity of ocular GVHD based on historical records in the hematology service of the University Hospital U.A.N.L. in patients without prophylactic treatment, as assessed by the National Institutes of Health Consensus on Chronic GVHD scoring system. measure: Number of participants requiring adjuvant treatment for ocular GVHD in patients receiving prophylactic tacrolimus or cyclosporine for ocular GVHD. measure: Prevalence of Dry Eye Disease prior to the HSCT. measure: Subtypes of Dry Eye Disease prior to the HSCT measure: Number of participants requiring adjuvant treatments for the Dry Eye Disease measure: Incidence of other manifestations of acute and chronic GVHD, local or systemic, in patients receiving prophylactic treatment for ocular GVHD. measure: Number of participants with topical tacrolimus related adverse events as assessed by a questionnaire for evaluation of adverse drug events measure: Number of participants with topical cyclosporine related adverse events as assessed by a questionnaire for evaluation of adverse drug events measure: Incidence of ocular GVHD in patients receiving prophylactic treatment for ocular GVHD. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Universitario de la U.A.N.L. status: RECRUITING city: Nuevo León state: Monterrey zip: 66640 country: Mexico name: Olga Graciela Cantú Rodriguez, MD role: CONTACT phone: 8186939257 email: ogcantur@yahoo.com.mx name: David Gómez Almaguer, MD role: CONTACT phone: 8186756718 email: dgomezalmaguer@gmail.com hasResults: False