Actively Recruiting
A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of STSP-0902 ophthalmic solution in adults with neurotrophic keratitis (NK), a condition affecting the cornea. This Phase II, double-blind, placebo-controlled study will enroll 48 patients diagnosed with Mackie Stage 2 or 3 NK in one or both eyes. The goal is to better understand how this eye drop treatment impacts corneal healing and eye health compared to placebo. Participants will be randomly assigned to one of three dosing groups: low dose given three times daily, low dose given six times daily, or high dose given three times daily. Each group will include both patients receiving the active drug and those receiving a placebo. Treatments will be applied topically to the affected eye(s) for 8 weeks. If the eye is not healed after this period, patients may receive standard care during follow-up. During the study, participants will undergo various eye exams including slit-lamp exams, optical coherence tomography, and intraocular pressure measurements from screening through week 10. Researchers will monitor symptoms, vital signs, lab tests, and heart activity. Corneal healing, sensitivity, vision quality, tear secretion, and presence of antibodies against the drug will also be assessed. The total participation time includes the 8-week treatment and follow-up periods ending around week 10.
CONDITIONS
Brief 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, classified as Mackie Stage 2 (PED) or Stage 3 (corneal ulcer), with a maximum corneal defect diameter of 2 mm or less
- Reduced or absent corneal sensitivity in the defect area and at least one adjacent corneal quadrant, confirmed by aesthesiometer or cotton swab test
- Neurotrophic keratitis duration longer than 2 weeks in the study eye
- No improvement in the study eye for at least 7 days prior to randomization
- Effective non-pharmacological contraception used throughout the trial and for 3 months after last dose, with no plans for pregnancy or gamete donation
- Voluntarily signed informed consent and willingness to comply with study procedures and follow-ups
You will not qualify if you...
- Corneal stromal ulceration involving more than one-third of corneal thickness or risk of corneal melting/perforation
- Active infection (bacterial, viral, fungal, amoebic, chlamydial) or ocular inflammation unrelated to neurotrophic keratitis
- Other ocular diseases in study eye requiring topical medication besides allowed adjunctive treatments
- Severe bilateral vision loss impacting daily life
- Study eye with Schirmer I test 3 mm or less in 5 minutes
- Severe lagophthalmos, eyelid margin disease, or meibomian gland dysfunction affecting corneal healing
- Ocular surgery in study eye within 3 months prior to randomization or planned during trial, except NK-related surgeries
- Prior surgical intervention for neurotrophic keratitis that may affect efficacy assessments, or amniotic membrane transplantation within 6 weeks prior
- Botulinum toxin injections to levator muscle within 3 months prior or planned during trial
- Requirement to wear contact lenses during trial
- History of poor response to nerve growth factor eye drops
- Use of autologous serum eye drops, growth factor-containing ocular meds, NSAIDs, corticosteroids, neurotoxic drugs, or systemic immunosuppressants within specified periods before randomization or planned during trial
- Poorly controlled systemic or ocular conditions that may affect study compliance
- Known hypersensitivity to study drug or components
- History of drug abuse or alcohol dependence
- Participation in another interventional trial within 3 months prior or planned during trial
- Female participants who are pregnant, breastfeeding, test positive for pregnancy, or fail to use effective contraception
- Difficulty administering eye drops, venous blood sampling, or history of needle phobia/vasovagal syncope
- Any other condition deemed unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants receive STSP-0902 ophthalmic solution or placebo eye drops to the affected eye(s) multiple times daily for 8 weeks.
Multiple visits during the 8-week treatment period
Duration - Up to 2 weeks after treatment
Participants are monitored for safety and efficacy outcomes after treatment ends, up to Week 10.
Visits up to Week 10 for assessments
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
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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