A Phase II Study of STSP-0902 Ophthalmic Solution in Patients With Neurotrophic Keratitis
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 thre
| Condition(s) | Neurotrophic Keratitis |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | 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 |
| Who can participate | Inclusion Criteria: 1. Male or female patients aged between 18 to 85 years (inclusive). 2. 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. 3. 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. 4. NK duration \>2 weeks in the study eye, as confirmed by the investigator based on medical history. 5. No improvement in the study eye for ≥7 days prior to randomization. 6. Effective non-pharmacological contraception used by the subject (and partner, if applicable) throughout the trial and for 3 mont |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Lead sponsor | Staidson (Beijing) Biopharmaceuticals Co., Ltd |
| Locations | Jinan, Shandong, China |
| Start date | 2025-06-12 |
| NCT ID | NCT06975748 |
| Official listing | https://clinicaltrials.gov/study/NCT06975748 |