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

Recruiting Phase 2 Interventional Study
Neurotrophic Keratitis
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 85
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
48 (estimated)
Sponsor
Staidson (Beijing) Biopharmaceuticals Co., Ltd · Industry
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About This Trial
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 act…
Trial Locations
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Eligibility Criteria
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 sensitiv…
Contacts

Wanchun Huai

+86-13311368335

huaiwanchun@staidson.com

CONTACT