This is a Phase II, double-blind, placebo-controlled study to evaluate the safety and efficacy of STSP-0902 ophthalmic solution in patients with neurotrophic keratitis (NK). The study plans to enroll 48 patients with Mackie Stage 2 or 3 NK affecting one or both eyes. Eligible subjects will be randomized 1:1:1 into three dosing groups. Each dosing group will follow a drug-placebo allocation (12 active: 4 placebo). Treatment involves topical ocular administration for 8 weeks. Subjects who are not healed after the 8 weeks of masked treatment period will be permitted to receive standard of care during the follow-up period
Male or female patients aged between 18 to 85 years (inclusive).
Diagnosed with NK in one or both eyes, with the study eye classified as Mackie Stage 2 (PED) or Stage 3 (corneal ulcer), and with a maximum corneal defect diameter ≥2 mm.
Reduced or absent corneal sensitivity in the defect area and at least 1 adjacent corneal quadrant, confirmed by: ≤40 mm using the aesthesiometer or cotton swab test demonstrating marked reduction or absence of corneal sensitivity.
NK duration >2 weeks in the study eye, as confirmed by the investigator based on medical history.
Any eye with corneal stromal ulceration involving >1/3 of corneal thickness or at risk of corneal melting/perforation.
Active infection (bacterial, viral, fungal, amoebic, chlamydial) in any eye, or active ocular inflammation unrelated to NK.
Study eye with other ocular diseases requiring topical medication apart from the prescribed adjunctive treatments during the trial.
Bilateral vision loss severely impacting daily life, as assessed by the investigator.
Parallel
STSP-0902 ophthalmic solution
DrugEye drop, 3 times daily for 8 weeks
STSP-0902 ophthalmic solution
DrugEye drop, 6 times daily for 8 weeks
STSP-0902 Placebo
DrugEye drop, 3 or 6 times daily for 8 weeks
Incidence of Adverse Events
Number of participants with ocular and systemic adverse events as assessed by CTCAE v5.0.
Ocular Symptoms and Signs
Number of subjects with clinically significant changes in ocular symptoms and signs.
Intraocular Pressure (IOP) Measurements
Change in IOP is measured using a non-contact tonometer (In cases requiring precise IOP evaluation, a contact tonometer may be used).
Slit-Lamp Examinations
Number of subjects with clinically significant changes detected by slit-lamp microscope. The slit lamp examinations will encompass the eyelids, conjunctiva, cornea, anterior chamber, aqueous humor, iris, lens, and other relevant ocular structures.
Corneal Healing
Percentage of subjects achieving corneal healing assessed via corneal fluorescein staining by the investigator
Corneal Sensitivity
Evaluation of sensation in corneal quadrants using the aesthesiometer
Patients with Deterioration
Percentage of Subjects with Disease Deterioration
Best Corrected Visual Acuity (BCVA)
Change in BCVA from Baseline
Click on the lead sponsor to view all of their trials.
