New eye drops aim to heal corneal damage and restore sensation
NCT ID NCT06975748
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests an experimental eye drop called STSP-0902 for people with neurotrophic keratitis, a rare condition where the cornea loses sensation and can develop ulcers. The trial will enroll 48 adults with moderate to severe disease. Participants will receive either the active eye drop or a placebo, applied 3 or 6 times daily for 8 weeks. The main goals are to check safety and see if the drops help heal the cornea and improve eye sensation.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- STSP-0902 ophthalmic solution (eye drops)
- What this could lead to
- If it works, this could provide a new treatment option to heal corneal damage and restore sensation in people with neurotrophic keratitis.
- What could go wrong
- This is an early Phase 2 trial with only 48 participants, so results may not apply to everyone. The treatment may not work better than placebo, and eye drops can cause irritation or other side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 48 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jun 2025
- Expected to finish
-
Apr 2026
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 85 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male or female patients aged between 18 to 85 years (inclusive). 2. 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. 3. 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. 4. NK duration \>2 weeks in the study eye, as confirmed by the investigator based on medical history. 5. No improvement in the study eye for ≥7 days prior to randomization. 6. 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. 7. Voluntarily sign informed consent, with willingness and ability to comply with study procedures, follow-ups, and assessments. Exclusion Criteria: 1. Any eye with corneal stromal ulceration involving \>1/3 of corneal thickness or at risk of corneal melting/perforation. 2. Active infection (bacterial, viral, fungal, amoebic, chlamydial) in any eye, or active ocular inflammation unrelated to NK. 3. Study eye with other ocular diseases requiring topical medication apart from the prescribed adjunctive treatments during the trial. 4. Bilateral vision loss severely impacting daily life, as assessed by the investigator. 5. Study eye with Schirmer I test ≤3 mm/5 minutes. 6. Severe lagophthalmos, eyelid margin disease, or meibomian gland dysfunction in the study eye that may impair corneal healing or trial outcomes. 7. 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. 8. 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. 9. Study eye with botulinum toxin injections to the levator muscle within 3 months prior to randomization or planned during the trial. 10. Requirement to wear contact lenses during the trial. 11. History of inefficacy or poor response to nerve growth factor (NGF) eye drops in any eye. 12. 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. 13. Use of NSAIDs, or corticosteroids in the study eye within 1 week prior to randomization or planned during the trial. 14. 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. 15. 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. 16. Known hypersensitivity to the study drug, its excipients, or components of trial-related ophthalmic tests (e.g., fluorescein). 17. History of drug abuse or alcohol dependence. 18. Participation in another interventional trial (drugs, devices, or vaccines) within 3 months prior to randomization or planned during this trial. 19. 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. 20. Difficulty administering eye drops, venous blood sampling, or history of needle phobia/vasovagal syncope. 21. Any other condition deemed unsuitable for trial participation by the investigator.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Neurotrophic keratitis are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Shandong First Medical University Affiliated Eye Hospital
RECRUITINGJinan, Shandong, 250021, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New eye drops show promise for healing corneal damage
- New eye drops aim to heal damaged corneas
- New eye drop shows promise for rare corneal disease
- Gene therapy eye drops aim to heal corneas in rare nerve disorder
- Could a simple ingredient boost dry eye drops?
- New eye test could unlock secrets of ocular pain