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New treatment option for Neurotrophic Keratitis
Official title A Phase II Study of STSP-0902 Ophthalmic Solution in Patients With Neurotrophic Keratitis
ClinicalTrials.gov ID: NCT06975748
What this study is testing
What is STSP-0902 ophthalmic solution?
STSP-0902 ophthalmic solution is an investigational medicine, given as an once-daily treatment applied to the skin, being studied as a potential treatment for neurotrophic keratitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- 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...
- Reduced or absent corneal sensitivity in the defect area and at least 1 adjacent corneal quadrant, confirmed by: ≤40 mm using the aesthesiometer or...
- 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.
You likely can't join if
- 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.
See the full eligibility 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...
- 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.
- 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...
- Study eye with prior surgical intervention for NK (e.g., tarsorrhaphy, conjunctival flap) that may confound how well it works 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(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 (e.g., antipsychotics, antiepileptics, antihistamines) or systemic immunosuppressants within 4 weeks prior to randomization or planned during the trial, excluding those who have been using it...
- Poorly controlled systemic or ocular conditions (e.g., diabetic retinopathy, uveitis, autoimmune diseases, malignancies, psychiatric disorders) that may confound how well it works assessments or compliance, as judged by...
- 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 treatment trial (drugs, devices, or vaccines) within 3 months prior to randomization or planned during this trial.
- Female people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Jinan, Shandong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jinan, Shandong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.