Neurotrophic KeratitisPhase 2NCT06975748

A Phase II Study of STSP-0902 Ophthalmic Solution in Patients With Neurotrophic Keratitis

A Phase 2 study testing STSP-0902 ophthalmic solution in people with Neurotrophic Keratitis, run by Staidson (Beijing) Biopharmaceuticals Co., Ltd at 1 site in China.

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Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Neurotrophic Keratitis
What is being tested?: STSP-0902 ophthalmic solution
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 48 participants
Where: 1 siteChina
Study dates: 12 Jun 2025to Apr 2026
Phase: Phase 2
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 21Show fewer

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.
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 stably for at least 4 weeks before enrollment.
Poorly controlled systemic or ocular conditions (e.g., diabetic retinopathy, uveitis, autoimmune diseases, malignancies, psychiatric disorders) that may confound efficacy assessments or compliance, as judged by the investigator.
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 interventional trial (drugs, devices, or vaccines) within 3 months prior to randomization or planned during this trial.
Female subjects 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Wanchun Huai contact

+86-13311368335

huaiwanchun@staidson.com

China1 site, 1 recruiting

Shandong First Medical University Affiliated Eye Hospital
Jinan, Shandong, 250021
Weiyun Shi, 0531-81276111, weiyunshi@163.com
Ting Wang, 13869182795, wt-ting@163.com
Recruiting

Other trials in China

About this study

Official title: 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

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

Conditions: Neurotrophic Keratitis
Being tested: STSP-0902 ophthalmic solution, STSP-0902 Placebo
Keywords: STSP-0902, Ophthalmic Solution, Neurotrophic Keratitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

STSP-0902 ophthalmic solutionDrug
Eye drop, 3 times daily for 8 weeks
STSP-0902 ophthalmic solutionDrug
Eye drop, 6 times daily for 8 weeks
STSP-0902 PlaceboDrug
Eye drop, 3 or 6 times daily for 8 weeks

Study groups in NCT06975748
Study group	Role	What they receive
Low Dose 3 Times Daily Arm	Experimental	Low dose of STSP-0902 ophthalmic solution to the affected eye(s), 3 times daily for 8 weeks Receives: Drug: STSP-0902 ophthalmic solution
Low Dose 6 Times Daily Arm	Experimental	Low dose of STSP-0902 ophthalmic solution to the affected eye(s), 6 times daily for 8 weeks Receives: Drug: STSP-0902 ophthalmic solution
High Dose 3 Times Daily Arm	Experimental	High dose of STSP-0902 ophthalmic solution to the affected eye(s), 3 times daily for 8 weeks Receives: Drug: STSP-0902 ophthalmic solution
Control Arm	Placebo comparator	STSP-0902 Placebo to the affected eye(s), 3 or 6 times daily for 8 weeks Receives: Drug: STSP-0902 Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of Adverse Events
Number of participants with ocular and systemic adverse events as assessed by CTCAE v5.0.
Measured: Screening to Week 10
Ocular Symptoms and Signs
Number of subjects with clinically significant changes in ocular symptoms and signs.
Measured: Screening to Week 10
Intraocular Pressure (IOP) Measurements
Change in IOP is measured using a non-contact tonometer (In cases requiring precise IOP evaluation, a contact tonometer may be used).
Measured: Screening to Week 10
Slit-Lamp Examinations
Number of subjects with clinically significant changes detected by slit-lamp microscope. The slit lamp examinations will encompass the eyelids, conjunctiva, cornea, anterior chamber, aqueous humor, iris, lens, and other relevant ocular structures.
Measured: Screening to Week 10
Optical Coherence Tomography (OCT) Results
Proportion of corneal thickness affected by the stromal ulceration, as evaluated by the investigator.
Measured: Screening to Week 10
Clinically Significant Changes in Vital Signs
Vital signs include body temperature in ℃, pulse rate in bpm, respiration rate in breaths/ minute, and blood pressure in mmHg.
Measured: Screening to Week 10
Clinically Significant Changes in Physical Examinations
Physical examinations include assessments of general status, skin and mucous membranes, lymph nodes, head and neck, chest, abdomen, musculoskeletal system, spine/extremities, nervous system, and additional regions as clinically indicated.
Measured: Screening to Week 10
Clinically Significant Changes in 12-Lead ECGs
Parameters measured: Heart rate in bpm, P-R interval in ms, QRS duration in ms, QT interval in ms, QTc interval in ms.
Measured: Screening to Week 10
Clinically Significant Laboratory Abnormalities
Blood samples will be collected for hematology, blood biochemistry and coagulation function. Urine sample will be collected for and urinalysis.
Measured: Screening to Week 10

Secondary outcomes (8)

Corneal Healing
Percentage of subjects achieving corneal healing assessed via corneal fluorescein staining by the investigator
Measured: Baseline to Week 10
Corneal Sensitivity
Evaluation of sensation in corneal quadrants using the aesthesiometer
Measured: Baseline to Week 10
Patients with Deterioration
Percentage of Subjects with Disease Deterioration
Measured: Baseline to Week 10
Best Corrected Visual Acuity (BCVA)
Change in BCVA from Baseline
Measured: Baseline to Week 8
Tear Secretion
Change in Tear Secretion from Baseline as evaluated via Schirmer I test
Measured: Baseline to Week 8
Visual Quality of Life Assessed Using the NEI-VFQ-25
VFQ-25 is a questionnaire composed of 25 vision-targeted questions assessing 11 vision-related constructs, along with a single-item question to rate general health. Original responses from the questionnaire are recoded to a scale ranging from 0 to 100, where a higher score indicates better visual function. Each question corresponds to one of the 12 sub-scales and scores for each sub-scale are calculated by averaging its constituent questions. The overall composite score is generated by averaging the 11 vision-specific sub-scales, excluding the general health item.
Measured: Baseline to Week 8
STSP-0902 concentration
Measurement of STSP-0902 in plasma after drug administration
Measured: Baseline to Week 10
Incidence of positive detection of anti-STSP-0902 antibodies
Measurement of anti-drug antibody (ADA) to STSP-0902 in plasma after drug administration
Measured: Baseline to Week 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Jun 2025Apr 2026

First posted16 May 2025
Study start12 Jun 2025
Primary completionApr 2026 (estimated)
Study completionApr 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Neurotrophic KeratitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 48 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06975748
Sponsor's protocol ID: STSP-0902-02-002
Status last verified: Apr 2026
First submitted: 15 Apr 2025
Last updated: 7 Apr 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT06975748
Acronym / sponsor ID: STSP-0902-02-002
Conditions: Neurotrophic Keratitis
Keywords: STSP-0902, Ophthalmic Solution, Neurotrophic Keratitis
Phase: Phase 2
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 48 participants (estimated)
Lead sponsor: Staidson (Beijing) Biopharmaceuticals Co., LtdIndustry (pharma, biotech, devices)
Study start: 12 Jun 2025 (actual)
Primary completion: Apr 2026 (estimated)
Study completion: Apr 2026 (estimated)
First posted: 16 May 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Low Dose 3 Times Daily Arm	Experimental	Drug: STSP-0902 ophthalmic solutionLow dose of STSP-0902 ophthalmic solution to the affected eye(s), 3 times daily for 8 weeks
Low Dose 6 Times Daily Arm	Experimental	Drug: STSP-0902 ophthalmic solutionLow dose of STSP-0902 ophthalmic solution to the affected eye(s), 6 times daily for 8 weeks
High Dose 3 Times Daily Arm	Experimental	Drug: STSP-0902 ophthalmic solutionHigh dose of STSP-0902 ophthalmic solution to the affected eye(s), 3 times daily for 8 weeks
Control Arm	Placebo comparator	Drug: STSP-0902 PlaceboSTSP-0902 Placebo to the affected eye(s), 3 or 6 times daily for 8 weeks

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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.

Key exclusion criteria (21 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
STSP-0902 ophthalmic solutionEye drop, 3 times daily for 8 weeks	Drug	High Dose 3 Times Daily Arm, Low Dose 3 Times Daily Arm
STSP-0902 ophthalmic solutionEye drop, 6 times daily for 8 weeks	Drug	Low Dose 6 Times Daily Arm
STSP-0902 PlaceboEye drop, 3 or 6 times daily for 8 weeks	Drug	Control Arm

Primary outcome

Incidence of Adverse Events
Time frame: Screening to Week 10
Number of participants with ocular and systemic adverse events as assessed by CTCAE v5.0.
Ocular Symptoms and Signs
Time frame: Screening to Week 10
Number of subjects with clinically significant changes in ocular symptoms and signs.
Intraocular Pressure (IOP) Measurements
Time frame: Screening to Week 10
Change in IOP is measured using a non-contact tonometer (In cases requiring precise IOP evaluation, a contact tonometer may be used).
Slit-Lamp Examinations
Time frame: Screening to Week 10
Number of subjects with clinically significant changes detected by slit-lamp microscope. The slit lamp examinations will encompass the eyelids, conjunctiva, cornea, anterior chamber, aqueous humor, iris, lens, and other relevant ocular structures.
Optical Coherence Tomography (OCT) Results
Time frame: Screening to Week 10
Proportion of corneal thickness affected by the stromal ulceration, as evaluated by the investigator.
Clinically Significant Changes in Vital Signs
Time frame: Screening to Week 10
Vital signs include body temperature in ℃, pulse rate in bpm, respiration rate in breaths/ minute, and blood pressure in mmHg.
Clinically Significant Changes in Physical Examinations
Time frame: Screening to Week 10
Physical examinations include assessments of general status, skin and mucous membranes, lymph nodes, head and neck, chest, abdomen, musculoskeletal system, spine/extremities, nervous system, and additional regions as clinically indicated.
Clinically Significant Changes in 12-Lead ECGs
Time frame: Screening to Week 10
Parameters measured: Heart rate in bpm, P-R interval in ms, QRS duration in ms, QT interval in ms, QTc interval in ms.
Clinically Significant Laboratory Abnormalities
Time frame: Screening to Week 10
Blood samples will be collected for hematology, blood biochemistry and coagulation function. Urine sample will be collected for and urinalysis.

8 secondary outcomes

Corneal Healing
Time frame: Baseline to Week 10
Corneal Sensitivity
Time frame: Baseline to Week 10
Patients with Deterioration
Time frame: Baseline to Week 10
Best Corrected Visual Acuity (BCVA)
Time frame: Baseline to Week 8
Tear Secretion
Time frame: Baseline to Week 8
Visual Quality of Life Assessed Using the NEI-VFQ-25
Time frame: Baseline to Week 8
STSP-0902 concentration
Time frame: Baseline to Week 10
Incidence of positive detection of anti-STSP-0902 antibodies
Time frame: Baseline to Week 10

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Wanchun Huai contact

+86-13311368335

huaiwanchun@staidson.com

Weiyun Shi, Ph.D principal investigator

Shandong First Medical University Affiliated Eye Hospital

Ting Wang, Ph.D principal investigator

Shandong First Medical University Affiliated Eye Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing STSP-0902 ophthalmic solution in people with Neurotrophic Keratitis, run by Staidson (Beijing) Biopharmaceuticals Co., Ltd at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Wanchun Huai (+86-13311368335, huaiwanchun@staidson.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Adverse Events (time frame: Screening to Week 10). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06975748.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.