Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
A phase 2 study, aiming to evaluate the efficacy, safety and pharmacokinetics of REC 0/0559
in treatment of Neurotrophic Keratitis in Adult Patient in Europe and United States of
America.
Phase
Phase 2
Funding Agency/Sponsor
Industry
Disease
Cornea
Enrollment Eligibility
Inclusion Criteria:
1. Have read, understood, and signed the informed consent form (ICF).
2. Be a male or female aged ≥18 years at the time of ICF signature.
3. Have stage 2 moderate (PED) or stage 3 severe (corneal ulcer) NK involving only 1 eye
(study eye) and of at least 2 weeks duration. Patients with Stage 1 NK in the fellow
eye can be enrolled.
for the study eye
4. Have no objective clinical evidence of improvement in the PED or corneal ulceration
within the 2 weeks before the screening visit despite use of conventional non-surgical
treatment (eg, nonpreserved ocular lubricants, nonpreserved topical antibiotics, oral
doxycycline, patching, serum tears, and/or therapeutic contact lenses) as determined
by the investigator's or referring physician's medical record.
5. Have decreased corneal sensitivity (≤ 4 cm using the Cochet-Bonnet aesthesiometer)
within the area of the PED or corneal ulcer and outside of the area of the defect in
at least one corneal quadrant.
6. Have a BCDVA score ≤ 75 ETDRS letters in the study eye, due to NK.
Exclusion Criteria:
1. Have participated in any clinical trial with an investigational drug/device within 2
months before the Screening Visit and throughout the study duration.
2. Have a known hypersensitivity to one of the components of the study drug or procedural
medications (eg, fluorescein), including to a compound chemically related to MT8
3. Have a presence or history of any ocular or systemic disorder or condition that might
hinder the efficacy of the study treatment or its evaluation, could possibly interfere
with the interpretation of study results, or could be judged by the investigator to be
incompatible with the study visit schedule or conduct (eg, progressive or degenerative
corneal or retinal conditions, lagophthalmos, uveitis, optic neuritis, poorly
controlled diabetes, autoimmune disease, systemic infection, neoplastic diseases), or
that may compromise the safety of the patient.
4. Have a significant history of alcohol abuse or drug/solvent abuse
5. Be unwilling to comply with any study assessments or procedures.
6. Be a woman who is pregnant, nursing or planning a pregnancy.
7. Be a woman of childbearing potential not using a highly effective method of birth
control.
8. Be a male patient who is not permanently sterile and who is not willing to use condoms
during the study and for 4 weeks after the end of study treatment.
For the study eye:
9. Have any active ocular infection (bacterial, viral, fungal or protozoal) or active
inflammation not related to NK in the study eye.
10. Have any other ocular disease requiring topical ocular treatment in the study eye
during the course of the study treatment period, except for glaucoma if treated by
preservative-free eye drop (single-agent treatment, once daily, stable regimen 4 weeks
before screening and during the study),
11. Receive topical ophthalmological treatments other than the study drug provided by the
study Sponsor and the treatments allowed by the study protocol (eg, preservative-free
artificial tears; preservative-free eye drop (single-agent treatment, once daily,
stable regimen 4 weeks before screening and during the study) for glaucoma; topical
antibiotics; other than tetracycline).
12. Have severe blepharitis and/or severe meibomian gland disease in the study eye.
13. Have severe vision loss in the study eye with no potential for visual improvement in
the opinion of the investigator as a result of the study treatment.
14. Have evidence of corneal ulceration/melting involving the posterior third of the
corneal stroma, or perforation in the study eye.
15. Have a history of any ocular surgery (including laser or refractive surgical
procedures) within 3 months before the Screening Visit in the study eye. An exception
to the preceding statement will be allowed if the ocular surgery is considered to be
the cause of the Stage 2 or 3 NK.
16. Have a history of corneal transplantation in the study eye, except if performed to
treat NK and at least 6 months prior screening.
17. Have had prior surgical procedures for the treatment of NK (eg, tarsorrhaphy,
conjunctival flap, etc.) except AMT, if at least 2 wks after the membrane has
disappeared within the area of the PED or corneal ulcer (and at least 6 weeks after
the procedure) in the study eye.
18. Use therapeutic contact lenses or wear contact lenses for refractive correction during
the study treatment periods in the eye(s) with NK.
19. Have an anticipated need for punctal occlusion during the study treatment period.
Patients with punctal occlusion or punctal plugs inserted before the study are
eligible for enrolment provided that the punctal occlusion is maintained during the
study.
20. Have an uncontrolled glaucoma at the Screening Visit. (Patients suffering from
glaucoma requiring ophthalmic drops for topical treatment at the Screening Visit or
during the study are not eligible, except if the ophthalmic drops is a
preservative-free treatment administered maximum once daily as a single-agent
treatment and at a stable regimen 4 weeks before screening and at the same dose during
the study. Patients treated with oral intraocular pressure-lowering drugs at the
Screening Visit and during the study may be enrolled if their glaucoma status is
assessed as stable and controlled.
For the fellow eye
21. Have Stage 2 or 3 NK or perforation.
For any eye:
22. Have a history of ocular cancer.
23. Have had prior treatment with Oxervate™