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-IT
• Lead Sponsor: Recordati Rare Diseases

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-28
• Last Update Posted: 5 April 2021

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 (= 4cm 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 52

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