Clinical Trial

A Phase II Study of STSP-0902 Ophthalmic Solution in Patients With Neurotrophic Keratitis

Recruiting Phase 2
View on ClinicalTrials.gov →
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
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-05-08; most recent amendment 2026-04-01.
Status change: Not Yet Recruiting → Recruiting 2025-07-03
Trial Details
NCT Number NCT06975748
Lead Sponsor Staidson (Beijing) Biopharmaceuticals Co., Ltd
Conditions Neurotrophic Keratitis
Enrollment 48 participants
Start Date 2025-06-12
Primary Completion 2026-04 (estimated)
Study Completion 2026-04 (estimated)
Updated on ClinicalTrials.gov 2026-04-07