protocolSection identificationModule nctId: NCT06348602, orgStudyIdInfo id: PI23-00201, briefTitle: Evaluation of Safety & Efficacy for the Prevention of Ocular GVHD With Ophthalmic Tacrolimus vs Cyclosporine in Allo-HSCT, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Hospital Universitario Dr. Jose E. Gonzalez, class: OTHER, descriptionModule 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., conditionsModule conditions: Ocular Graft-versus-host Disease, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Experimental, prospective, randomized, unblinded., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Cyclosporine ophthalmic solution 0.1%, interventions name: Tacrolimus ophthalmic ointment 0.03%, outcomesModule primaryOutcomes 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., secondaryOutcomes 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., secondaryOutcomes 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, secondaryOutcomes 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., secondaryOutcomes 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., secondaryOutcomes 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., secondaryOutcomes measure: Number of participants requiring adjuvant treatment for ocular GVHD in patients receiving prophylactic tacrolimus or cyclosporine for ocular GVHD., secondaryOutcomes measure: Prevalence of Dry Eye Disease prior to the HSCT., secondaryOutcomes measure: Subtypes of Dry Eye Disease prior to the HSCT, secondaryOutcomes measure: Number of participants requiring adjuvant treatments for the Dry Eye Disease, secondaryOutcomes measure: Incidence of other manifestations of acute and chronic GVHD, local or systemic, in patients receiving prophylactic treatment for ocular GVHD., secondaryOutcomes measure: Number of participants with topical tacrolimus related adverse events as assessed by a questionnaire for evaluation of adverse drug events, secondaryOutcomes measure: Number of participants with topical cyclosporine related adverse events as assessed by a questionnaire for evaluation of adverse drug events, otherOutcomes measure: Incidence of ocular GVHD in patients receiving prophylactic treatment for ocular GVHD., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Universitario de la U.A.N.L., status: RECRUITING, city: Nuevo León, state: Monterrey, zip: 66640, country: Mexico, contacts name: Olga Graciela Cantú Rodriguez, MD, role: CONTACT, phone: 8186939257, email: ogcantur@yahoo.com.mx, contacts name: David Gómez Almaguer, MD, role: CONTACT, phone: 8186756718, email: dgomezalmaguer@gmail.com, hasResults: False