Evaluation of Safety and Efficacy of rhNGF in Patients With Stage 2 and 3 Neurotrophic Keratitis.

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

174

Participants

Timeline

Start Date

January 31, 2013

Primary Completion Date

April 30, 2015

Study Completion Date

May 31, 2016

Conditions
Neurotrophic KeratitisKeratitisCorneal Ulcer
Interventions
DRUG

rhNGF 10 μg/ml

rhNGF 10 μg/ml : one drop 6 times a day (one 35 μl drop equals to 0.35 μg of rhNGF)

DRUG

rhNGF 20 μg/ml

one drop 6 times a day (one 35 μl drop equals to 0.70 μg of rhNGF)

OTHER

vehicle

ophthalmic solution of the same composition as the test product without rhNGF

Trial Locations (34)

16132

Dipartimento di Scienze Neurologiche Oftalmologia e Genetica - Universtità di Genova, Genoa

20132

OSPEDALE SAN RAFFAELE di Milano, Milan

20142

Azienda Ospedaliera San Paolo - U.O. Oculistica, Milan

21000

CHU de Dijon - Service ophtalmologie, Dijon

28040

Hospital Clínico San Carlos - Oftalmología. Unidad de Superficie Ocular, Madrid

31059

"CHU Toulouse-Purpan - Service Ophtalmologie", Toulouse

33012

Instituto Oftalmológico Fernández-Vega - Oftalmología, Oviedo

35128

Azienda ospedaliera di Padova - Clinica Oculistica Policlinico 7° Piano, Padua

41092

Cartuja Visión - Oftalmología, Seville

48903

Hospital de Cruces - Oftalmología, Barakaldo

50124

Azienda Ospedaliero Universitaria Careggi, Florence

50924

Universität zu Köln - Zentrum für Augenheilkunde am Universitätsklinikum Köln, Cologne

University Eye Clinic in Düsseldorf, Düsseldorf

55131

Johannes-Gutenberg-Universität Augenklinik und Poliklinik - Department of Ophthalmology, Mainz

66100

Università G. D' Annunzio - Clinica Oftalmologica - Centro regionale di Eccellenza in Oftalmologia, Chieti

75019

"Fondation Ophtalmologique Adolphe de Rothschild - Unité de Recherche Clinique", Paris

79106

Universitäts-Augenklinik Freiburg, Freiburg im Breisgau

80336

Klinikum der Universität München - Augenklinik der Ludwig-Maximilians-Universtiät München, München

87042

CHU Dupuytren - Service Ophtalmologie, Limoges

91054

Universitätsklinikum Erlangen, Erlangen

98125

Azienda Ospedaliero Universitaria di Messina - Dipartimento Specialità Chirurgiche Ambulatorio Studio delle Malattie dela Superficie Oculare Unità Operativa Complessa di Oftalmologia, Messina

75 571

Centre Hospitalier National d'Ophtalmologie - Service d'ophtalmologie, Paris

00128

Università Campus Bio-Medico di Roma, Rome

00161

Policlinico Umberto I, Rome

40-760

District Railway Hospital Katowice - Department of Ophthalmology, Katowice

03-709

"SPKSO Szpital Okulistyczny ul. - SPKSO Szpital Okulistyczny", Warsaw

03016

Vissum Corporación Oftalmológica de Alicante, Alicante

08021

Barraquer Eye center, Barcelona

08028

Hospital Clinic de Barcelona - Oftalmología, Barcelona

"B15 2TT"

University of Birmingham - Academic Unit of Ophthalmology, School of Immunity and Infection, College of Medical and Dental Sciences, University of Birmingham, Birmingham

EC1V 2PD

Moorfields Eye Hospital - Moorfields Eye Hospital, London

M13 9WL

Manchester Royal Eye Hospital - Manchester Royal Eye Hospital, Manchester

NE1 4LP

Royal Victoria Infirmary - Dept. of Ophthalmology, Newcastle upon Tyne

SO16 6YD

University of Southampton Southampton General Hospital - MP104, Eye Unit, Southampton

All Listed Sponsors
lead

Dompé Farmaceutici S.p.A

INDUSTRY

NCT01756456 - Evaluation of Safety and Efficacy of rhNGF in Patients With Stage 2 and 3 Neurotrophic Keratitis. | Biotech Hunter | Biotech Hunter