NIPH Clinical Trials Search

Exploratory Clinical Study on the Safety and Preliminary Efficacy of TLM-017 for Ocular Graft-Versus-Host Disease

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Ocular GVHD
Date of first enrollment	30/01/2026
Target sample size	16
Countries of recruitment
Study type	Interventional
Intervention(s)	This study consists of two steps : Step 1 with a single-day administration and Step 2 with consecutive-day administration. In Step 1, a dose-escalation design will be applied between cohorts (two different concentrations administered to separate cohorts), while in Step 2, a dose-escalation design will be applied within a cohort (two different concentrations administered to the same cohort). 1)Step 1 - Low-Concentration Cohort TLM-017 ophthalmic solution at a low concentration (0.01%) will be administered as eye drops four times in a single day. 2)Step 1 - High-Concentration Cohort TLM-017 ophthalmic solution at a high concentration (0.1%) will be administered as eye drops four times in a single day. 3)Step 2 TLM-017 ophthalmic solution at a low concentration (0.01%) will be administered as eye drops four times daily for 28 consecutive days. After an off-treatment period of at least four weeks (28 days), TLM-017 ophthalmic solution at a high concentration (0.1%) will be administered as eye drops four times daily for 28 consecutive days.

Outcome(s)

Primary Outcome	Incidence of local ocular adverse events
Secondary Outcome	1)Change from baseline in ocular GVHD severity score (total score) (Step 2 only) 2)Incidence of adverse events other than ocular local events

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	Patients who meet all of the following criteria will be included in this study: 1)Male or female patients aged 18 years or older at the time of obtaining consent. 2)Patients who underwent hematopoietic stem cell transplantation and have been diagnosed with ocular GVHD meeting the following criterion: patients who have at least one eye with total score of ocular GVHD severity score between 6 and 11 (inclusive). 3)Patients who have provided written informed consent to participate in this study.
Exclude criteria	Patients who meet any of the following criteria will be excluded from this study: 1)Patients with active acute GVHD at the time of obtaining consent. 2)Patients with ocular pemphigoid or Stevens-Johnson syndrome. 3)Patients with glaucoma in both eyes (including normal-tension glaucoma). In addition, pre-perimetric glaucoma is included. 4)Patients with active ocular infection or ocular allergy, or those who wear contact lenses. 5)Patients with a history of severe drug allergy. 6)Patients who underwent ophthalmic surgery, including eyelid surgery, within 6 months prior to obtaining consent. 7)Patients scheduled to receive radiation therapy during the study period. 8)Patients who participated in other clinical research or trials and received medical interventions before obtaining consent, and there is a possibility that any influences of the intervention have remained on the patient, or patients who plan to participate in another clinical study or trial during the study period. 9)Patients who have changed their treatment for GVHD within 28 days prior to screening, or patients who are planning to change their treatment during the study period. 10)Female patients who are pregnant or breastfeeding. 11)Female patients who are willing to become pregnant during the study period (including the off-treatment period). 12)Patients deemed by the investigator to have other issues that would interfere with study participation.