NCT06975748

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

A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of STSP-0902 Ophthalmic Solution in Patients With Neurotrophic Keratitis

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Conditions

• Neurotrophic Keratitis

Interventions

Type	Name	Description
DRUG	STSP-0902 ophthalmic solution	Eye drop, 3 times daily for 8 weeks
DRUG	STSP-0902 ophthalmic solution	Eye drop, 6 times daily for 8 weeks
DRUG	STSP-0902 Placebo	Eye drop, 3 or 6 times daily for 8 weeks

Timeline

• Start date: 2025-06-12
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2025-05-16
• Last updated: 2026-04-07

Locations

1 site across 1 country: China