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 - REC0559-B-001

Recordati Rare Diseases0 个研究点目标入组 108 人开始时间: 2021年1月28日最近更新: 2021年4月5日

研究概览

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•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

•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).

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