Actively Recruiting
A Phase II Study of STSP-0902 Ophthalmic Solution in Patients With Neurotrophic Keratitis
Led by Staidson (Beijing) Biopharmaceuticals Co., Ltd · Updated on 2026-04-07
48
Participants Needed
1
Research Sites
41 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Phase II Study of STSP-0902 Ophthalmic Solution in Patients With Neurotrophic Keratitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged between 18 to 85 years (inclusive).
- Diagnosed with neurotrophic keratitis 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 652 mm.
- Reduced or absent corneal sensitivity in the defect area and at least 1 adjacent corneal quadrant, confirmed by 6440 mm using the aesthesiometer or cotton swab test demonstrating marked reduction or absence of corneal sensitivity.
- Neurotrophic keratitis duration greater than 2 weeks in the study eye, as confirmed by the investigator based on medical history.
- No improvement in the study eye for at least 7 days prior to randomization.
- Effective non-pharmacological contraception used by the subject (and partner, if applicable) throughout the trial and for 3 months after the last dose, with no plans for pregnancy or gamete donation.
- Voluntarily sign informed consent, with willingness and ability to comply with study procedures, follow-ups, and assessments.
You will not qualify if you...
- Any eye with corneal stromal ulceration involving more than one-third of the corneal thickness or at risk of corneal melting or perforation.
- Active infection (bacterial, viral, fungal, amoebic, chlamydial) in any eye, or active ocular inflammation unrelated to neurotrophic keratitis.
- Study eye with other ocular diseases requiring topical medication apart from the prescribed adjunctive treatments during the trial.
- Bilateral vision loss severely impacting daily life, as assessed by the investigator.
- Study eye with Schirmer I test 3 mm or less per 5 minutes.
- Severe lagophthalmos, eyelid margin disease, or meibomian gland dysfunction in the study eye that may impair corneal healing or trial outcomes.
- Study eye with any surgery within 3 months prior to randomization (including corneal/non-corneal surgeries affecting trial assessments, except surgeries related to neurotrophic keratitis etiology), or planned ocular surgery during the trial.
- Study eye with prior surgical intervention for neurotrophic keratitis (e.g., tarsorrhaphy, conjunctival flap) that may confound efficacy assessments, or amniotic membrane transplantation within 6 weeks prior to randomization.
- Study eye with botulinum toxin injections to the levator muscle within 3 months prior to randomization or planned during the trial.
- Requirement to wear contact lenses during the trial.
- History of inefficacy or poor response to nerve growth factor eye drops in any eye.
- Use of autologous serum eye drops, deproteinized calf blood extracts, or other growth factor-containing ocular medications in the study eye(s) planned during the trial.
- Use of NSAIDs or corticosteroids in the study eye within 1 week prior to randomization or planned during the trial.
- Use of neurotoxic drugs or systemic immunosuppressants within 4 weeks prior to randomization or planned during the trial, excluding those stably using them for at least 4 weeks before enrollment.
- Poorly controlled systemic or ocular conditions that may confound efficacy assessments or compliance.
- Known hypersensitivity to the study drug, its excipients, or components of trial-related ophthalmic tests.
- History of drug abuse or alcohol dependence.
- Participation in another interventional trial within 3 months prior to randomization or planned during this trial.
- Female subjects who are pregnant, breastfeeding, or test positive for serum pregnancy; or who fail to use effective contraception as required.
- Difficulty administering eye drops, venous blood sampling, or history of needle phobia or vasovagal syncope.
- Any other condition deemed unsuitable for trial participation by the investigator.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Shandong First Medical University Affiliated Eye Hospital
Jinan, Shandong, China, 250021
Actively Recruiting
Research Team
W
Wanchun Huai
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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