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

Phase 1

Conditions: eurotrophic Keratitis
MedDRA version: 20.0Level: PTClassification code 10069732Term: Neurotrophic keratopathySystem Organ Class: 10015919 - Eye disorders
Therapeutic area: Diseases [C] - Eye Diseases [C11]

Registration Number: EUCTR2019-002475-34-HU

Lead Sponsor: Recordati Rare Diseases

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 108

Inclusion Criteria

1. Be a male or female aged = 18 years
2. 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.
3. 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.
4. 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.
5. Have a BCDVA score = 75 ETDRS letters in the study eye, due to NK.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 54
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 54

Exclusion Criteria

Individuals meeting any of the following criteria at the Screening Visit are ineligible to participate in this study.
For the study eye:
1. Have severe blepharitis and/or severe meibomian gland disease in the study eye.
2. 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.
3. Have evidence of corneal ulceration/melting involving the posterior third of the corneal stroma, or perforation in the study eye.
4. Have a history of corneal transplantation in the study eye.
5. Have had prior surgical procedures for the treatment of NK (except amniotic membrane transplantation,
6. Have an uncontrolled glaucoma at the Screening Visit
7. Have Stage 2 or 3 NK or perforation.
8. Have had prior treatment with Oxervate (cenegermin eye drops).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: • In the first 24 patients, to determine the safety, tolerability and PK profile of REC 0/0559 (MT8) given as 1 drop 4 times a day (QID) of escalating doses up to 50 µg/mL.<br>• To determine the efficacy and safety of MT8 given as 1 drop QID at 5, 25, and 50 µg/mL during 8 weeks and select the dose with the best benefit risk ratio.;Secondary Objective: Not applicable;Primary end point(s): The primary endpoint of this study is the percentage of patients achieving complete corneal healing of persistent epithelial defects (PED) or corneal ulcer at Week 8, defined as no corneal fluorescein staining in the area of the PED or corneal ulcer as assessed by an independent central reading centre.;Timepoint(s) of evaluation of this end point: week 8

Secondary Outcome Measures

Name	Time	Method

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