chronic ocular graft-versus-host disease
Conditions
Interventions
Group 1:Totaling 1 wearing in all with low-dose formulation
Group 2:Totaling 1 wearing in all with medium-dose formulation
Group 3:Totaling 1 wearing in all with high-dose formulation
Group 4:Totaling 6 wearings in all with medium-dose formulation
Group 5:Totaling 6 wearings in all with high-dose formulation
Group 6:Totaling 6 wearings in all with high-dose formulation
Group 7:Totaling 6 wearings in all with high-dose formulation
Sponsors
Beijing Tongren Hospital, CMU
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Aged 18-65 years old, of any gender. (2) Patients diagnosed with coGVHD caused by hematopoietic stem cell transplantation, with at least 3 months post-transplantation. (3) Meet the clinical diagnostic criteria for coGVHD in the eye: presence of at least one of the following symptoms in either eye: 1) Dryness, burning, foreign body sensation, ocular discomfort, or decreased vision; 2) Total score in either eye >= 8 in the absence of systemic cGVHD symptoms, or >= 6 in the presence of systemic cGVHD symptoms. (Total score = Schirmer I test score + CFS score + OSDI score + conjunctival congestion). Note: Only one eye is chosen as the study eye. If both the left and right eyes of a subject meet the clinical diagnostic criteria for coGVHD, the eye with the higher coGVHD score will be chosen as the study eye. If both eyes have the same score, the right eye will be chosen as the study eye. (4) Patients have a corneal fluorescein staining score >= 2 points in any area of the same eye during both the screening visit and the baseline visit.; (5) Patients have a OSDI score >= 13 points during the screening visit.; (6) Eye-related symptoms treated conventionally for 1 week prior to screening with no improvement or inadequate response (severity not reduced based on the grading scale of ocGVHD). (7) Karnofsky Performance Status (KPS) score >60. (8) Subjects and their partners must not have a pregnancy plan within 6 months from screening to the end of the trial and agree to effective non-pharmacological contraceptive measures during the trial. (9) Willing to participate in the study, understand and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Known allergy to any component of the investigational drug. (2) Subjects who have previously undergone stem cell drug therapy (Except for MSCohi-O Lenses (the investigational drug in this clinical trial)). (3) Subjects with any unstable or uncontrolled cardiovascular, pulmonary, gastrointestinal, genitourinary, coagulation, immunological, endocrine, metabolic, or other medical conditions deemed by the investigator to interfere with the study results or pose a risk to subject safety. (4) Patients with active fungal, bacterial, or viral keratitis or conjunctivitis, or any other acute eye infections, will be excluded during the screening period. In addition, any situation assessed by the researcher that may increase the risk or may affect the subjects’ compliance or outcome assessment will also be excluded. (5) Patients who have undergone eye surgery within the previous 3 months. (6) Patients who have participated in clinical trials of new drugs other than vitamin - related ones, and for whom the interval between the last administration of the trial medication (including investigational drugs, control drugs, and other related trial medications) and the enrollment time of this clinical trial is less than five drug half - lives; or patients who have participated in clinical trials related to ophthalmic devices within three months. (7) Systemic diseases or psychiatric histories assessed by the investigator to potentially increase the subject's risk or affect the evaluation of study results. (8) Positive test results for human immunodeficiency virus antibodies, Treponema pallidum-specific antibodies (syphilis), positive hepatitis C antibodies, positive hepatitis C virus RNA, surface antigen of hepatitis B or , history of hepatitis B, or positive hepatitis B core antibody, with recent HBV-DNA levels >= 2000IUmL in the past 3 months. (9) Patients with a history of malignant solid tumors are excluded, except for the following: those who have been cured of stage IB or lower cervical cancer, non-invasive basal cell or squamous cell skin cancer, malignant melanoma that has achieved complete remission (CR) for more than 10 years, and other malignant tumors that have achieved CR for more than 5 years. (10) Pregnant or lactating women. (11) Subjects deemed unsuitable for participation in this trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Event; | — |
Secondary
| Measure | Time frame |
|---|---|
| Corneal Fluorescein Staining;Ocular Surface Disease Index;Schirmer I test;Conjunctival congestion score;Total severity score of ocular chronic graft-versus-host disease; | — |
Countries
China
Contacts
Public ContactYing Jie
Beijing Tongren Hospital, CMU
Outcome results
None listed