What is STSP-0902 studying for neurotrophic keratitis?

STSP-0902 is being studied to evaluate its safety and effectiveness in treating neurotrophic keratitis, a condition affecting the cornea. This Phase II clinical trial aims to compare different doses of the eye drop with a placebo to understand its impact on corneal healing and eye health.

Who may be eligible for this neurotrophic keratitis clinical trial?

Adults aged 18 to 85 with diagnosed neurotrophic keratitis affecting one or both eyes may be eligible. Participants must have specific stages of corneal damage and no active eye infections unrelated to the condition. Please review eligibility criteria for more details.

Is there any cost to participate in this neurotrophic keratitis clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 2

Age: 18Years - 85Years

All Genders

ID06975748

Phase II Study of STSP-0902 Eye Drops for Treating Neurotrophic Keratitis in Adults

Led by Staidson (Beijing) Biopharmaceuticals Co., Ltd · Updated on 2026-04-07

Participants Needed

Research Sites

N/A

Total Duration

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 eyes 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

Age: 18Years - 85Years

All Genders

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

Research Team

Wanchun Huai

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Phase II Study of STSP-0902 Eye Drops for Treating Neurotrophic Keratitis in Adults

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria