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RECRUITING
NCT06975748
PHASE2

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

Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2025-06-12

Completion Date

2026-04

Last Updated

2026-04-07

Healthy Volunteers

No

Interventions

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

Locations (1)

Shandong First Medical University Affiliated Eye Hospital

Jinan, Shandong, China