A Phase II Study of STSP-0902 Ophthalmic Solution in Patients With Neurotrophic Keratitis (NCT06975748) | Clinical Trial Compass
RecruitingPhase 2
A Phase II Study of STSP-0902 Ophthalmic Solution in Patients With Neurotrophic Keratitis
China48 participantsStarted 2025-06-12
Plain-language 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
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female patients aged between 18 to 85 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Adverse Events
Timeframe: Screening to Week 10
2
Ocular Symptoms and Signs
Timeframe: Screening to Week 10
3
Intraocular Pressure (IOP) Measurements
Timeframe: Screening to Week 10
4
Slit-Lamp Examinations
Timeframe: Screening to Week 10
5
Optical Coherence Tomography (OCT) Results
Timeframe: Screening to Week 10
6
Clinically Significant Changes in Vital Signs
Timeframe: Screening to Week 10
7
Clinically Significant Changes in Physical Examinations
. Voluntarily sign informed consent, with willingness and ability to comply with study procedures, follow-ups, and assessments.
Exclusion criteria
. 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 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/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.