Moderate to severe neurotrophic keratitis
Conditions
Interventions
20µg/mLgroup:The experimental drug was dropped in the conjunctival sac of the single eye, 20µg/mL.
60µg/mLgroup:The experimental drug was dropped in the conjunctival sac of the single eye, 60µg/mL.
20µg/mL placebo group:Intraocular conjunctival capsule intravenous placebo was studied.
60µg/mL placebo group:Intraocular conjunctival capsule intravenous placebo was studied.
Sponsors
Beijing Tongren Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients aged 18 years or older, regardless of gender. 2. The study eye is diagnosed with moderate (stage 2, i.e., persistent epithelial defect, PED) or severe (stage 3, i.e., corneal ulcer) neurotrophic keratitis (NK). 3. The study eye has a history of corneal epithelial defect or corneal ulcer for at least 2 weeks. 4. The study eye has reduced corneal sensation (measured by Cochet-Bonnet esthesiometer <=40 mm) in at least one quadrant both within and outside the area of PED or corneal ulcer. 5. The study eye is refractory to one or more previous traditional non-surgical treatments for NK (e.g., preservative-free artificial tears, gels or ointments, discontinuation of drugs that reduce corneal sensitivity, therapeutic contact lenses, etc.). 6. No improvement of PED or corneal ulcer was found in the study eye within 2 weeks before enrollment. 7. Have no plans for childbearing (including sperm donation and egg donation) from the signing of the informed consent form until 3 months after the last administration of the drug, and be willing to take effective non-pharmacological contraceptive measures. 8. Voluntarily participate in this trial, be fully informed, understand and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. As judged by the investigator, the study eye has active ocular infection (such as bacterial, viral, fungal or protozoan) unrelated to NK or active ocular inflammation unrelated to NK. 2. During this trial, the study eye requires treatment for other ocular diseases. 3. The depth of the corneal ulcer in the study eye exceeds one-third of the thickness of the corneal stroma, or the cornea is significantly thinned, with a risk of corneal melting or corneal perforation. 4. NK caused by congenital diseases. 5. Have a surgical plan during the clinical study. 6. The study eye has severe blepharitis or severe meibomian gland disease. 7. The study eye has lagophthalmos, eyelid defect, entropion or ectropion. 8. The best corrected distance visual acuity (standard logarithmic visual acuity chart, decimal record) of the study eye is < 0.1. 9. The study eye has used artificial tears with the effect of promoting corneal epithelial repair (such as 0.3% sodium hyaluronate eye drops) within 3 days before enrollment, or has used other prohibited medications as specified in the protocol within 7 days before enrollment. 10. Has used or is expected to use systemic medications known to damage the function of the trigeminal nerve (such as neuroleptics or antihistamines, etc.) within 4 weeks before enrollment or during the expected trial. 11. The study eye has undergone ophthalmic surgery, such as eyelid surgery, cataract surgery, filtration or drainage valve surgery, laser surgery, refractive surgery, etc., within 6 months before enrollment in the trial, except for ophthalmic surgery received due to NK (see exclusion criteria 12 and 13). 12. The study eye has received surgical treatment for NK, such as tarsorrhaphy, conjunctival flap covering, lamellar or penetrating keratoplasty, nerve transplantation surgery, etc., except for amniotic membrane transplantation (see exclusion criteria 13). 13. If the amniotic membrane within the area of PED and corneal ulcer in the study eye has not been completely absorbed 2 weeks after amniotic membrane transplantation, or the amniotic membrane transplantation is less than 6 weeks old. 14. After receiving botulinum toxin treatment, due to the presence of pharmacological ptosis, these patients can only be enrolled 3 months after the last injection and when there is no clinical evidence of pharmacological ptosis at the time of enrollment. 15. The study eye needs to wear therapeutic contact lenses or contact lenses for refractive correction within 2 weeks before enrollment and during this trial. 16. Existing or previous any ocular or systemic disorders or objective factors that may interfere with the clinical efficacy and evaluation (such as: progressive or degenerative ocular or retinal diseases, uveitis, optic neuritis, poorly controlled diabetes, autoimmune diseases, systemic infections, neoplastic diseases, etc.). 17. Has a history of drug or food allergy, is allergic to the components of the investigational drug, or is allergic to the reagents used in ophthalmic examinations such as sodium fluorescein. 18. Has a history of mental illness or is suspected to have a history of drug, medication or alcohol abuse or addiction. 19. Has used similar ocular drugs (nerve growth factor) or participated in clinical studies of similar drugs. 20. Has participated in a clinical study of drugs or medical devices within 4 weeks before enrollment. 21. Pregnant or lactating women. 22. The investigator deems it inappropriate for the subjec
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety;Tolerance; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of subjects in whom the cornea has healed to a maximum diameter of lesion staining < 0.5 mm at the 4th week of treatment.;The proportion of subjects in whom the cornea is completely healed (0 mm lesion staining and no other persistent staining outside the lesion area) at the 4th week of treatment.;Pharmacokinetic characteristics;Immunogenicity characteristics; | — |
Countries
China
Contacts
Public ContactJie Ying
Beijing Tongren Hospital, Capital Medical University
Outcome results
None listed