Ocular Graft-versus-host DiseasePhase 1/2NCT06348602
Evaluation of Safety & Efficacy for the Prevention of Ocular GVHD With Ophthalmic Tacrolimus vs Cyclosporine in Allo-HSCT
A Phase 1/2 study testing Cyclosporine ophthalmic solution 0.1% and Tacrolimus ophthalmic ointment 0.03% in people with Ocular Graft-versus-host Disease, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
Trial summary
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%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ocular Graft-versus-host Disease
- What is being tested?
- Cyclosporine ophthalmic solution 0.1% and Tacrolimus ophthalmic ointment 0.03%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteMexico
- Study dates
- 1 Aug 2023to 31 Dec 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing allogeneic HSCT.
- Patients 18 years of age or older.
- Patients who agree to participate in the study and sign the informed consent document.
Who cannot join
- Patients undergoing HSCT who do not continue their evaluation and follow-up in the Hematology Service of the University Hospital.
- Patients under 18 years of age.
- Patients who do not agree to participate in the study.
- Patients diagnosed with previous rheumatic disease.
- Patients with dermatological conditions undergoing systemic treatment.
- Patients with uncontrolled thyroid disease.
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Hospital Universitario de la U.A.N.L.
Nuevo León, Monterrey, 66640
Olga Graciela Cantú Rodriguez, MD, 8186939257, ogcantur@yahoo.com.mx
David Gómez Almaguer, MD, 8186756718, dgomezalmaguer@gmail.com
About this study
Official title: Evaluation of Safety and Efficacy for the Prevention of Ocular Graft-versus-host Disease With Ophthalmic Tacrolimus vs. Ophthalmic Cyclosporine in Non-myeloablative Allogeneic Hematopoietic Stem Cell Transplant Recipients
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.
Read the detailed description
After being informed about the study and potential risks, all patients giving written informed consent will be assigned a participant number to anonymize their data and collect information, including age, sex, diagnosis, stage of disease, type of procedure, and conditioning chemotherapy. Additionally, an ophthalmology evaluation will be conducted in the Ophthalmology Department of the University Hospital of the U.A.N.L. by the study team of ophthalmologists, following a standardized method and using a worksheet for dry eye and ocular surface evaluation.
Participants will be randomized to receive either treatment arm A (cyclosporine eye drops) or treatment arm B (tacrolimus ointment) through a stratified method. After the hematopoietic stem cell transplant (HSCT), information will be collected, such as the transplant details (e.g., number of cluster of differentiation 34 [CD34] cells infused, cell source, and any complications during the procedure) and medications used for the systemic GVHD prophylaxis, as well as the graft date. In addition to the standard systemic management protocol for GVHD prevention of the transplant program of the Hematology Service of the Hospital University U.A.N.L. cyclosporine or tacrolimus will be administered to participants once grafting is demonstrated, defined as the presence in the blood count of a neutrophil count that is equal to or greater than to 500/mm3 and platelet count equal to or greater than 20,000/mm3.
- Treatment arm A: topical cyclosporine 0.1% ocular drops, twice daily, one drop in each eye, with a 12-hour difference between each dose, for 12 continuous months. The commercial presentation that we will use has the following formula: Each milliliter of 0.1% solution contains Cyclosporine A 10 mg, c.b.p 1.0 ml.
- Treatment arm B: tacrolimus ointment, to be applied approximately 1cm or the amount to cover the lower fornix twice a day in each eye, with a difference of 12 hours between each dose, for 12 continuous months. The presentation of the medicine in ointment has a 10 gr tube with 0.03% drug.
Ophthalmological evaluations will be carried out at the initial visit (before the bone marrow transplant) and scheduled subsequent visits: at the time of transplant graft (variable depending on the type of transplant, between days +10 and +21 approximately), and 3, 6, 9, and 12 months from the start of treatment (day of graft). Also, they will be evaluated during all follow-up visits to the transplant department of the Hematology Service, assessing adherence and tolerance to the medication through direct questioning. The severity of ocular GVHD will be established based on the NIH criteria and the severity criteria of the international consensus on the severity of chronic ocular GVHD (ICCGVHD)
Ophthalmological variables to be evaluated
- Tear breakup time, Schirmer's test, esthesiometry, Keratograph 5M Topographer Dry Eye Assessment, upper and lower tarsus Meibomian Gland imaging (Keratograph 5M), tear osmolarity, metalloproteinase 9 levels in tears.
- Corneal and conjunctival staining measured with the Oxford Scale and the Collaborative Longitudinal Evaluation of Keratoconus (CLEK) Scale and SICCA Ocular Staining Score (OSS).
- Conditions
- Ocular Graft-versus-host Disease
- Being tested
- Cyclosporine ophthalmic solution 0.1%, Tacrolimus ophthalmic ointment 0.03%
- Keywords
- Allogeneic, Hematopoietic Stem Cell Transplantation, Dry eye syndrome
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclosporine ophthalmic solution 0.1%Drug
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
Tacrolimus ophthalmic ointment 0.03%Drug
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
| Study group | Role | What they receive |
|---|---|---|
| Topical cyclosporine | Active comparator | Topical cyclosporine ophthalmic solution 0.1%, with a dosage of 1 drop in each eye every 12 hours, continued for a duration of 12 continuous months.
Composition: Each ml contains Cyclosporine A 0.1% w/v (1 mg/ml) in a sterile aqueous vehicle q.s. Receives: Drug: Cyclosporine ophthalmic solution 0.1% |
| Topical tacrolimus | Experimental | Topical tacrolimus ophthalmic ointment 0.03%, with a dosage of approximately 1 cm or the necessary amount to cover the lower fornix, every 12 hours, continued for a duration of 12 continuous months Composition: Each gram contains Tacrolimus 0.03% w/w (0.3 mg/g) in a sterile ointment base q.s. Receives: Drug: Tacrolimus ophthalmic ointment 0.03% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Severity based on an aggregate of scores of the following parameters: Schirmer's test [mm] (0, >15; 1, 11-15; 2, 6-10; 3, ≤5), Corneal fluorescein staining [points] (0, 0; 1, <2; 2, 2-3; 3, ≥4), Ocular Surface Disease Index [points] (0, <13; 1, 13-22; 2, 23-32; 3, ≥33), Conjunctival injection [points] (0, None; 1, Mild/Moderate; 2, Severe). Graded as none (0-4 points), mild/moderate (5-8 points) and severe (9-11 points), where higher scores mean a worse outcome.
Measured: 2.5 years
Secondary outcomes (12)
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.
Severity graded from 0 to 3 as follows: 0: No symptoms; 1: mild dry eye symptoms not affecting activity of daily living (requiring eye drops ≤3 x per day); 2: Moderate dry eye symptoms partially affecting activity of daily living (requiring eye drops >3 x per day or punctal plugs) WITHOUT new vision impairment due to keratoconjunctivitis sicca; 3: Severe dry eye symptoms significantly affecting activity of daily living (special eyewear to relieve pain) OR unable to work because of ocular symptoms OR loss of vision due to keratoconjunctivitis sicca. Note: higher scores mean a worse outcome.
Measured: 2.5 years
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
Severity based on an aggregate of scores of the following parameters: Schirmer's test [mm] (0, >15; 1, 11-15; 2, 6-10; 3, ≤5), Corneal fluorescein staining [points] (0, 0; 1, <2; 2, 2-3; 3, ≥4), Ocular Surface Disease Index [points] (0, <13; 1, 13-22; 2, 23-32; 3, ≥33), Conjunctival injection [points] (0, None; 1, Mild/Moderate; 2, Severe). Graded as none (0-4 points), mild/moderate (5-8 points) and severe (9-11 points), where higher scores mean a worse outcome.
Measured: 10 years
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.
Severity based on an aggregate of scores of the following parameters: Schirmer's test [mm] (0, >15; 1, 11-15; 2, 6-10; 3, ≤5), Corneal fluorescein staining [points] (0, 0; 1, <2; 2, 2-3; 3, ≥4), Ocular Surface Disease Index [points] (0, <13; 1, 13-22; 2, 23-32; 3, ≥33), Conjunctival injection [points] (0, None; 1, Mild/Moderate; 2, Severe). Graded as none (0-4 points), mild/moderate (5-8 points) and severe (9-11 points), where higher scores mean a worse outcome.
Measured: 10 years
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.
Severity graded from 0 to 3 as follows: 0: No symptoms; 1: mild dry eye symptoms not affecting activity of daily living (requiring eye drops ≤3 x per day); 2: Moderate dry eye symptoms partially affecting activity of daily living (requiring eye drops >3 x per day or punctal plugs) WITHOUT new vision impairment due to keratoconjunctivitis sicca; 3: Severe dry eye symptoms significantly affecting activity of daily living (special eyewear to relieve pain) OR unable to work because of ocular symptoms OR loss of vision due to keratoconjunctivitis sicca. Note: higher scores mean a worse outcome.
Measured: 10 years
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.
Severity graded from 0 to 3 as follows: 0: No symptoms; 1: mild dry eye symptoms not affecting activity of daily living (requiring eye drops ≤3 x per day); 2: Moderate dry eye symptoms partially affecting activity of daily living (requiring eye drops >3 x per day or punctal plugs) WITHOUT new vision impairment due to keratoconjunctivitis sicca; 3: Severe dry eye symptoms significantly affecting activity of daily living (special eyewear to relieve pain) OR unable to work because of ocular symptoms OR loss of vision due to keratoconjunctivitis sicca. Note: higher scores mean a worse outcome.
Measured: 10 years
Number of participants requiring adjuvant treatment for ocular GVHD in patients receiving prophylactic tacrolimus or cyclosporine for ocular GVHD.
e.g topical corticosteroids
Measured: 2.5 years
Prevalence of Dry Eye Disease prior to the HSCT.
Evaluation of dry eye symptoms with the ocular surface disease index (OSDI), National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25), tear breakup time, schirmer test.
Measured: 2.5
Subtypes of Dry Eye Disease prior to the HSCT
Evaluation of dry eye symptoms with the ocular surface disease index (OSDI), National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25), tear breakup time, schirmer test.
Measured: 2.5
Number of participants requiring adjuvant treatments for the Dry Eye Disease
e.g.eye lubricant, artificial tears, autologous serum or autologous platelet-rich plasma in drops.
Measured: 2.5 years
Incidence of other manifestations of acute and chronic GVHD, local or systemic, in patients receiving prophylactic treatment for ocular GVHD.
With The National Institutes of Health (NIH) consensus criteria used to diagnose GVHD
Measured: 2.5 years
Number of participants with topical tacrolimus related adverse events as assessed by a questionnaire for evaluation of adverse drug events
Variables: frequency and severity (0-100) of burning sensation, pain, itching, discomfort, blurred vision, foreign body sensation, others.
Measured: 1 year
Number of participants with topical cyclosporine related adverse events as assessed by a questionnaire for evaluation of adverse drug events
Variables: frequency and severity (0-100) of burning sensation, pain, itching, discomfort, blurred vision, foreign body sensation, others.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start1 Aug 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ocular Graft-versus-host DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental, prospective, randomized, unblinded.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Dr. Jose E. Gonzalez
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Gomez Almaguer, Hospital Universitario Dr. Jose E. Gonzalez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06348602
- Sponsor's protocol ID
- PI23-00201
- Status last verified
- Apr 2024
- First submitted
- 30 Oct 2023
- Last updated
- 8 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jagasia MH, Greinix HT, Arora M, Williams KM, Wolff D, Cowen EW, Palmer J, Weisdorf D, Treister NS, Cheng GS, Kerr H, Stratton P, Duarte RF, McDonald GB, Inamoto Y, Vigorito A, Arai S, Datiles MB, Jacobsohn D, Heller T, Kitko CL, Mitchell SA, Martin PJ, Shulman H, Wu RS, Cutler CS, Vogelsang GB, Lee SJ, Pavletic SZ, Flowers ME. National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: I. The 2014 Diagnosis and Staging Working Group report. Biol Blood Marrow Transplant. 2015 Mar;21(3):389-401.e1. doi: 10.1016/j.bbmt.2014.12.001. Epub 2014 Dec 18.
PubMed 25529383Cantu-Rodriguez OG, Vazquez-Mellado A, Gonzalez-Trevino JL, Martinez-Garza DM, Gomez-De Leon A, Hawing-Zarate JA, Jaime-Perez JC, Gutierrez-Aguirre CH, Garza-Acosta AC, Mancias-Guerra C, Gonzalez-Llano O, Gonzalez-Cantu GA, Herrera-Rojas MA, Sada-Ovalle I, Gomez-Almaguer D. Cyclosporine A for the Prevention of Ocular Graft versus Host Disease in Allogeneic Hematopoietic Stem Cell Transplant Recipients Is Safe and Feasible. Acta Haematol. 2020;143(5):425-431. doi: 10.1159/000502405. Epub 2019 Sep 10.
PubMed 31505491Jung JW, Lee YJ, Yoon SC, Kim TI, Kim EK, Seo KY. Long-term result of maintenance treatment with tacrolimus ointment in chronic ocular graft-versus-host disease. Am J Ophthalmol. 2015 Mar;159(3):519-27.e1. doi: 10.1016/j.ajo.2014.11.035. Epub 2014 Dec 9.
PubMed 25498356
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Efficacy for the Prevention of Ocular Graft-versus-host Disease With Ophthalmic Tacrolimus vs. Ophthalmic Cyclosporine in Non-myeloablative Allogeneic Hematopoietic Stem Cell Transplant Recipients
- ClinicalTrials.gov ID
- NCT06348602
- Acronym / sponsor ID
- PI23-00201
- Conditions
- Ocular Graft-versus-host Disease
- Keywords
- Allogeneic, Hematopoietic Stem Cell Transplantation, Dry eye syndrome
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospital Universitario Dr. Jose E. GonzalezUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 4 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
After being informed about the study and potential risks, all patients giving written informed consent will be assigned a participant number to anonymize their data and collect information, including age, sex, diagnosis, stage of disease, type of procedure, and conditioning chemotherapy. Additionally, an ophthalmology evaluation will be conducted in the Ophthalmology Department of the University Hospital of the U.A.N.L. by the study team of ophthalmologists, following a standardized method and using a worksheet for dry eye and ocular surface evaluation.
Participants will be randomized to receive either treatment arm A (cyclosporine eye drops) or treatment arm B (tacrolimus ointment) through a stratified method. After the hematopoietic stem cell transplant (HSCT), information will be collected, such as the transplant details (e.g., number of cluster of differentiation 34 [CD34] cells infused, cell source, and any complications during the procedure) and medications used for the systemic GVHD prophylaxis, as well as the graft date. In addition to the standard systemic management protocol for GVHD prevention of the transplant program of the Hematology Service of the Hospital University U.A.N.L. cyclosporine or tacrolimus will be administered to participants once grafting is demonstrated, defined as the presence in the blood count of a neutrophil count that is equal to or greater than to 500/mm3 and platelet count equal to or greater than 20,000/mm3.
- Treatment arm A: topical cyclosporine 0.1% ocular drops, twice daily, one drop in each eye, with a 12-hour difference between each dose, for 12 continuous months. The commercial presentation that we will use has the following formula: Each milliliter of 0.1% solution contains Cyclosporine A 10 mg, c.b.p 1.0 ml.
- Treatment arm B: tacrolimus ointment, to be applied approximately 1cm or the amount to cover the lower fornix twice a day in each eye, with a difference of 12 hours between each dose, for 12 continuous months. The presentation of the medicine in ointment has a 10 gr tube with 0.03% drug.
Ophthalmological evaluations will be carried out at the initial visit (before the bone marrow transplant) and scheduled subsequent visits: at the time of transplant graft (variable depending on the type of transplant, between days +10 and +21 approximately), and 3, 6, 9, and 12 months from the start of treatment (day of graft). Also, they will be evaluated during all follow-up visits to the transplant department of the Hematology Service, assessing adherence and tolerance to the medication through direct questioning. The severity of ocular GVHD will be established based on the NIH criteria and the severity criteria of the international consensus on the severity of chronic ocular GVHD (ICCGVHD)
Ophthalmological variables to be evaluated
- Tear breakup time, Schirmer's test, esthesiometry, Keratograph 5M Topographer Dry Eye Assessment, upper and lower tarsus Meibomian Gland imaging (Keratograph 5M), tear osmolarity, metalloproteinase 9 levels in tears.
- Corneal and conjunctival staining measured with the Oxford Scale and the Collaborative Longitudinal Evaluation of Keratoconus (CLEK) Scale and SICCA Ocular Staining Score (OSS).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Experimental, prospective, randomized, unblinded.
| Arm | Type | Receives |
|---|---|---|
| Topical cyclosporine | Active comparator | Drug: Cyclosporine ophthalmic solution 0.1%Topical cyclosporine ophthalmic solution 0.1%, with a dosage of 1 drop in each eye every 12 hours, continued for a duration of 12 continuous months. Composition: Each ml contains Cyclosporine A 0.1% w/v (1 mg/ml) in a sterile aqueous vehicle q.s. |
| Topical tacrolimus | Experimental | Drug: Tacrolimus ophthalmic ointment 0.03%Topical tacrolimus ophthalmic ointment 0.03%, with a dosage of approximately 1 cm or the necessary amount to cover the lower fornix, every 12 hours, continued for a duration of 12 continuous months Composition: Each gram contains Tacrolimus 0.03% w/w (0.3 mg/g) in a sterile ointment base q.s. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing allogeneic HSCT.
- Patients 18 years of age or older.
- Patients who agree to participate in the study and sign the informed consent document.
Key exclusion criteria (6 listed)
- Patients undergoing HSCT who do not continue their evaluation and follow-up in the Hematology Service of the University Hospital.
- Patients under 18 years of age.
- Patients who do not agree to participate in the study.
- Patients diagnosed with previous rheumatic disease.
- Patients with dermatological conditions undergoing systemic treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Topical cyclosporine |
| 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 | Drug | Topical tacrolimus |
Primary outcome
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.
Time frame: 2.5 years
Severity based on an aggregate of scores of the following parameters: Schirmer's test [mm] (0, >15; 1, 11-15; 2, 6-10; 3, ≤5), Corneal fluorescein staining [points] (0, 0; 1, <2; 2, 2-3; 3, ≥4), Ocular Surface Disease Index [points] (0, <13; 1, 13-22; 2, 23-32; 3, ≥33), Conjunctival injection [points] (0, None; 1, Mild/Moderate; 2, Severe). Graded as none (0-4 points), mild/moderate (5-8 points) and severe (9-11 points), where higher scores mean a worse outcome.
12 secondary outcomes
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.
Time frame: 2.5 years
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
Time frame: 10 years
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.
Time frame: 10 years
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.
Time frame: 10 years
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.
Time frame: 10 years
Number of participants requiring adjuvant treatment for ocular GVHD in patients receiving prophylactic tacrolimus or cyclosporine for ocular GVHD.
Time frame: 2.5 years
Prevalence of Dry Eye Disease prior to the HSCT.
Time frame: 2.5
Subtypes of Dry Eye Disease prior to the HSCT
Time frame: 2.5
Number of participants requiring adjuvant treatments for the Dry Eye Disease
Time frame: 2.5 years
Incidence of other manifestations of acute and chronic GVHD, local or systemic, in patients receiving prophylactic treatment for ocular GVHD.
Time frame: 2.5 years
Number of participants with topical tacrolimus related adverse events as assessed by a questionnaire for evaluation of adverse drug events
Time frame: 1 year
Number of participants with topical cyclosporine related adverse events as assessed by a questionnaire for evaluation of adverse drug events
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
- Background: PubMed 25529383Jagasia MH, Greinix HT, Arora M, Williams KM, Wolff D, Cowen EW, Palmer J, Weisdorf D, Treister NS, Cheng GS, Kerr H, Stratton P, Duarte RF, McDonald GB, Inamoto Y, Vigorito A, Arai S, Datiles MB, Jacobsohn D, Heller T, Kitko CL, Mitchell SA, Martin PJ, Shulman H, Wu RS, Cutler CS, Vogelsang GB, Lee SJ, Pavletic SZ, Flowers ME. National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: I. The 2014 Diagnosis and Staging Working Group report. Biol Blood Marrow Transplant. 2015 Mar;21(3):389-401.e1. doi: 10.1016/j.bbmt.2014.12.001. Epub 2014 Dec 18.
- Results publication: PubMed 31505491Cantu-Rodriguez OG, Vazquez-Mellado A, Gonzalez-Trevino JL, Martinez-Garza DM, Gomez-De Leon A, Hawing-Zarate JA, Jaime-Perez JC, Gutierrez-Aguirre CH, Garza-Acosta AC, Mancias-Guerra C, Gonzalez-Llano O, Gonzalez-Cantu GA, Herrera-Rojas MA, Sada-Ovalle I, Gomez-Almaguer D. Cyclosporine A for the Prevention of Ocular Graft versus Host Disease in Allogeneic Hematopoietic Stem Cell Transplant Recipients Is Safe and Feasible. Acta Haematol. 2020;143(5):425-431. doi: 10.1159/000502405. Epub 2019 Sep 10.
- Results publication: PubMed 25498356Jung JW, Lee YJ, Yoon SC, Kim TI, Kim EK, Seo KY. Long-term result of maintenance treatment with tacrolimus ointment in chronic ocular graft-versus-host disease. Am J Ophthalmol. 2015 Mar;159(3):519-27.e1. doi: 10.1016/j.ajo.2014.11.035. Epub 2014 Dec 9.
- Multicenter prospective validation study for international chronic ocular graft-versus-host disease consensus diagnostic criteriaLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cyclosporine ophthalmic solution 0.1% and Tacrolimus ophthalmic ointment 0.03% in people with Ocular Graft-versus-host Disease, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olga Graciela Cantú Rodríguez, MD (8186939257, ogcantur@yahoo.com.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 2.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06348602, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2024.