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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Dose 3 Times Daily Arm | Experimental | Low dose of STSP-0902 ophthalmic solution to the affected eye(s), 3 times daily for 8 weeks |
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| Low Dose 6 Times Daily Arm | Experimental | Low dose of STSP-0902 ophthalmic solution to the affected eye(s), 6 times daily for 8 weeks |
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| High Dose 3 Times Daily Arm | Experimental | High dose of STSP-0902 ophthalmic solution to the affected eye(s), 3 times daily for 8 weeks |
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| Control Arm | Placebo Comparator | STSP-0902 Placebo to the affected eye(s), 3 or 6 times daily for 8 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STSP-0902 ophthalmic solution | Drug | Eye drop, 3 times daily for 8 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events | Number of participants with ocular and systemic adverse events as assessed by CTCAE v5.0. | Screening to Week 10 |
| Ocular Symptoms and Signs | Number of subjects with clinically significant changes in ocular symptoms and signs. | 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). | 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. | Screening to Week 10 |
| Optical Coherence Tomography (OCT) Results | Proportion of corneal thickness affected by the stromal ulceration, as evaluated by the investigator. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Corneal Healing | Percentage of subjects achieving corneal healing assessed via corneal fluorescein staining by the investigator | Baseline to Week 10 |
| Corneal Sensitivity | Evaluation of sensation in corneal quadrants using the aesthesiometer |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wanchun Huai | Contact | +86-13311368335 | huaiwanchun@staidson.com |
| Name | Affiliation | Role |
|---|---|---|
| Weiyun Shi, Ph.D | Shandong First Medical University Affiliated Eye Hospital | Principal Investigator |
| Ting Wang, Ph.D | Shandong First Medical University Affiliated Eye Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shandong First Medical University Affiliated Eye Hospital | Recruiting | Jinan | Shandong | 250021 | China |
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| STSP-0902 ophthalmic solution | Drug | Eye drop, 6 times daily for 8 weeks |
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| STSP-0902 Placebo | Drug | Eye drop, 3 or 6 times daily for 8 weeks |
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| 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. | 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. | Screening to Week 10 |
| Baseline to Week 10 |
| Patients with Deterioration | Percentage of Subjects with Disease Deterioration | Baseline to Week 10 |
| Best Corrected Visual Acuity (BCVA) | Change in BCVA from Baseline | Baseline to Week 8 |
| Tear Secretion | Change in Tear Secretion from Baseline as evaluated via Schirmer I test | 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. | Baseline to Week 8 |
| STSP-0902 concentration | Measurement of STSP-0902 in plasma after drug administration | 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 | Baseline to Week 10 |