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REC 0/0559 Eye Drops for Treatment of Moderate and Severe Neurotrophic Keratitis in Adult Patients | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

Efficacy, Safety and Pharmacokinetics of 3 Doses of REC 0/0559 Eye Drops for the Treatment of Stage 2 (Moderate) and 3 (Severe) Neurotrophic Keratitis in Adult Patients

NCT04276558•RECORDATI GROUP

View on ClinicalTrials.gov

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.

Detailed Description

This was a Phase 2, international, multicentre, dose-ranging, double-masked, randomised, parallel-group, vehicle-controlled study designed to evaluate 3 different doses of REC 0/0559 vs vehicle in patients with Stage 2 and Stage 3 neurotrophic keratitis (NK).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+15 more criteria

Locations (41)

Nature Coast Clinical Research

Crystal River, Florida, United States

University of Florida

Gainesville, Florida, United States

University of Maryland School of Medicine UMSOM

Baltimore, Maryland, United States

University of Michigan - Kellogg Eye Center

Ann Arbor, Michigan, United States

Mt. Sinai New York Eye and Ear Infirmary

New York, New York, United States

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States

Toyos Clinic

Nashville, Tennessee, United States

Houston Eye Associates HEA - Gramercy Location

Houston, Texas, United States

University of Wisconsin-Madison

Madison, Wisconsin, United States

Dijon University Hospital CHU Dijon

Dijon, France

Key Dates

Start Date

October 13, 2020

Primary Completion Date

April 29, 2024

Completion Date

April 29, 2024

Last Updated

May 14, 2025

Enrollment

108

ACTUAL participants

Conditions

Neurotrophic Keratitis

Interventions

Udonitrectag

DRUG

Vehicle

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 14, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study Comparing KB801 Verse Placebo in Patients With Stage 2 or 3 Neurotrophic Keratitis

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