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

NCT06975748 | Recruiting Phase 2

• 1 other identifier: STSP-0902-02-002
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Neurotrophic Keratitis

Keywords

STSP-0902; Ophthalmic Solution; Neurotrophic Keratitis

Outcome Measures

Primary Outcomes (9)

• Incidence of Adverse Events

  Number of participants with ocular and systemic adverse events as assessed by CTCAE v5.0.

  Screening to Week 10

• Ocular Symptoms and Signs

  Number of subjects with clinically significant changes in ocular symptoms and signs.

  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).

  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.

  Screening to Week 10

• Optical Coherence Tomography (OCT) Results

  Proportion of corneal thickness affected by the stromal ulceration, as evaluated by the investigator.

  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.

  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.

  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.

  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.

  Screening to Week 10

Secondary Outcomes (8)

• Corneal Healing

  Baseline to Week 10

• Corneal Sensitivity

  Baseline to Week 10

• Patients with Deterioration

  Baseline to Week 10

• Best Corrected Visual Acuity (BCVA)

  Baseline to Week 8

• Tear Secretion

  Baseline to Week 8

Study Arms (4)

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

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

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

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

Drug: STSP-0902 Placebo

Interventions

STSP-0902 ophthalmic solution DRUG

Eye drop, 3 times daily for 8 weeks

High Dose 3 Times Daily Arm; Low Dose 3 Times Daily Arm

STSP-0902 Placebo DRUG

Eye drop, 3 or 6 times daily for 8 weeks

Control Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients aged between 18 to 80 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.

You may not qualify 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 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.
• 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 within 3 days prior to randomization or planned during the trial.
• Use of NSAIDs, corticosteroids, or immunosuppressive eye drops 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.
• 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.

Sponsors & Collaborators

• Staidson (Beijing) Biopharmaceuticals Co., Ltd: lead

Study Sites (1)

Shandong First Medical University Affiliated Eye Hospital

Jinan, Shandong, 250021, China

RECRUITING

Study Officials

• Weiyun Shi, Ph.D

  Shandong First Medical University Affiliated Eye Hospital

  PRINCIPAL INVESTIGATOR

• Ting Wang, Ph.D

  Shandong First Medical University Affiliated Eye Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wanchun Huai

CONTACT

+86-13311368335; huaiwanchun@staidson.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: May 16, 2025
• Study Start: June 12, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: July 9, 2025

Record last verified: 2025-07

Locations

CN (1)