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 range18 Years – 85 Years
SexALL
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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.
✓. Voluntarily sign informed consent, with willingness and ability to comply with study procedures, follow-ups, and assessments.
Exclusion criteria
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
. 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.