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

NCT06975748 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-04-07

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Staidson (Beijing) Biopharmaceuticals Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Weiyun Shi, Ph.D · Shandong First Medical University Affiliated Eye Hospital

  • Ting Wang, Ph.D · Shandong First Medical University Affiliated Eye Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-12
Primary Completion
2026-04-30
Completion
2026-04-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06975748 on ClinicalTrials.gov