CompletedPhase 2

REC 0/0559 Eye Drops for Treatment of Moderate and Severe Neurotrophic Keratitis in Adult Patients

United States108 participantsStarted 2020-10-13

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Have read, understood, and signed the informed consent form (ICF).
✓. Be a male or female aged ≥18 years at the time of ICF signature.
✓. 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.
✓. 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.
✓. 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.
✓. Have a BCDVA score ≤ 75 ETDRS letters in the study eye, due to NK.

Exclusion criteria

✕. Have participated in any clinical trial with an investigational drug/device within 2 months before the Screening Visit and throughout the study duration.
✕. 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
✕. 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.
✕. Have a significant history of alcohol abuse or drug/solvent abuse
✕. Be unwilling to comply with any study assessments or procedures.
✕. Be a woman who is pregnant, nursing or planning a pregnancy.
✕. Be a woman of childbearing potential not using a highly effective method of birth control.
✕. 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.

What they're measuring

Corneal Healing

Timeframe: At week 8

Trial details

NCT IDNCT04276558

SponsorRECORDATI GROUP

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-04-29

Results submitted2025-04-02

View on ClinicalTrials.gov More Neurotrophic Keratitis trials