Status:
RECRUITING
A Phase II Study of STSP-0902 Ophthalmic Solution in Patients With Neurotrophic Keratitis
Lead Sponsor:
Staidson (Beijing) Biopharmaceuticals Co., Ltd
Conditions:
Neurotrophic Keratitis
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- Male or female patients aged between 18 to 80 years (inclusive).
- 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.
- Reduced or absent corneal sensitivity in the defect area and at least 1 adjacent corneal quadrant, confirmed by: ≤40 mm using the aesthesiometer or cotton swab test demonstrating marked reduction or absence of corneal sensitivity.
- NK duration \>2 weeks in the study eye, as confirmed by the investigator based on medical history.
- No improvement in the study eye for ≥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.
Exclusion
- Any eye with corneal stromal ulceration involving \>1/3 of corneal thickness or at risk of corneal melting/perforation.
- Active infection (bacterial, viral, fungal, amoebic, chlamydial) in any eye, or active ocular inflammation unrelated to NK.
- Study eye with other ocular diseases requiring topical medication during the trial.
- Bilateral vision loss severely impacting daily life, as assessed by the investigator.
- Study eye with Schirmer I test ≤3 mm/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 NK etiology), or planned ocular surgery during the trial.
- Study eye with prior surgical intervention for NK (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 (NGF) 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 within 3 days prior to randomization or planned during the trial.
- Use of NSAIDs, corticosteroids, or immunosuppressive eye drops in the study eye within 1 week prior to randomization or planned during the trial.
- Use of neurotoxic drugs (e.g., antipsychotics, antiepileptics, antihistamines) or systemic immunosuppressants within 4 weeks prior to randomization or planned during the trial.
- Poorly controlled systemic or ocular conditions (e.g., diabetic retinopathy, uveitis, autoimmune diseases, malignancies, psychiatric disorders) that may confound efficacy assessments or compliance, as judged by the investigator.
- Known hypersensitivity to the study drug, its excipients, or components of trial-related ophthalmic tests (e.g., fluorescein).
- History of drug abuse or alcohol dependence.
- Participation in another interventional trial (drugs, devices, or vaccines) 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 are failure to use effective contraception for 2 weeks prior to screening, during the trial, or for 3 months post-dosing.
- Difficulty administering eye drops, venous blood sampling, or history of needle phobia/vasovagal syncope.
- Any other condition deemed unsuitable for trial participation by the investigator.
Key Trial Info
Start Date :
June 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06975748
Start Date
June 12 2025
End Date
April 1 2026
Last Update
July 9 2025
Active Locations (1)
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1
Shandong First Medical University Affiliated Eye Hospital
Jinan, Shandong, China, 250021