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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
48
Eye drop, 3 times daily for 8 weeks
Eye drop, 6 times daily for 8 weeks
Eye drop, 3 or 6 times daily for 8 weeks
Shandong First Medical University Affiliated Eye Hospital
Jinan, Shandong, China
RECRUITINGIncidence of Adverse Events
Number of participants with ocular and systemic adverse events as assessed by CTCAE v5.0.
Time frame: Screening to Week 10
Ocular Symptoms and Signs
Number of subjects with clinically significant changes in ocular symptoms and signs.
Time frame: Screening to Week 10
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).
Time frame: Screening to Week 10
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.
Time frame: Screening to Week 10
Optical Coherence Tomography (OCT) Results
Proportion of corneal thickness affected by the stromal ulceration, as evaluated by the investigator.
Time frame: Screening to Week 10
Clinically Significant Changes in Vital Signs
Vital signs include body temperature in ℃, pulse rate in bpm, respiration rate in breaths/ minute, and blood pressure in mmHg.
Time frame: Screening to Week 10
Clinically Significant Changes in Physical Examinations
Physical examinations include assessments of general status, skin and mucous membranes, lymph nodes, head and neck, chest, abdomen, musculoskeletal system, spine/extremities, nervous system, and additional regions as clinically indicated.
Time frame: Screening to Week 10
Clinically Significant Changes in 12-Lead ECGs
Parameters measured: Heart rate in bpm, P-R interval in ms, QRS duration in ms, QT interval in ms, QTc interval in ms.
Time frame: Screening to Week 10
Clinically Significant Laboratory Abnormalities
Blood samples will be collected for hematology, blood biochemistry and coagulation function. Urine sample will be collected for and urinalysis.
Time frame: Screening to Week 10
Corneal Healing
Percentage of subjects achieving corneal healing assessed via corneal fluorescein staining by the investigator
Time frame: Baseline to Week 10
Corneal Sensitivity
Evaluation of sensation in corneal quadrants using the aesthesiometer
Time frame: Baseline to Week 10
Patients with Deterioration
Percentage of Subjects with Disease Deterioration
Time frame: Baseline to Week 10
Best Corrected Visual Acuity (BCVA)
Change in BCVA from Baseline
Time frame: Baseline to Week 8
Tear Secretion
Change in Tear Secretion from Baseline as evaluated via Schirmer I test
Time frame: Baseline to Week 8
Visual Quality of Life Assessed Using the NEI-VFQ-25
VFQ-25 is a questionnaire composed of 25 vision-targeted questions assessing 11 vision-related constructs, along with a single-item question to rate general health. Original responses from the questionnaire are recoded to a scale ranging from 0 to 100, where a higher score indicates better visual function. Each question corresponds to one of the 12 sub-scales and scores for each sub-scale are calculated by averaging its constituent questions. The overall composite score is generated by averaging the 11 vision-specific sub-scales, excluding the general health item.
Time frame: Baseline to Week 8
STSP-0902 concentration
Measurement of STSP-0902 in plasma after drug administration
Time frame: Baseline to Week 10
Incidence of positive detection of anti-STSP-0902 antibodies
Measurement of anti-drug antibody (ADA) to STSP-0902 in plasma after drug administration
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Time frame: Baseline to Week 10