3-year Study in Dry Eye Disease Patients With Severe Keratitis Receiving Ikervis® (1mg/mL Ciclosporin)

PHASE3CompletedINTERVENTIONAL
Enrollment

350

Participants

Timeline

Start Date

May 31, 2019

Primary Completion Date

July 14, 2023

Study Completion Date

July 14, 2023

Conditions
Dry Eye Disease With Severe Keratitis
Interventions
DRUG

Open-label Ikervis

NOVA22007, IKERVIS® is a sterile, ophthalmic cationic oil-in-water emulsion containing 1mg/ml CsA.

DRUG

Masked Ikervis

NOVA22007, IKERVIS® is a sterile, ophthalmic cationic oil-in-water emulsion containing 1mg/ml CsA.

OTHER

Vehicle Comparator: Masked Vehicle

Vehicle of IKERVIS® - sterile, ophthalmic cationic oil-in-water emulsion containing no active substance.

Trial Locations (45)

1364

Retina Szpital Okulistyczny, Warsaw

4001

Masarykova nemocnice, Ocni oddeleni, Ústí nad Labem

6620

Ankara Üniversitesi Tıp Fakültesi Göz Hastalıkları Anabilim Dalı Vehbi Koç Göz Hastanesi, Mamak

6680

Bayındır Kavaklidere Hospital Ophthalmology department, Ankara

8017

Institut Catala de Retina, Barcelona

8021

Centro de Oftalmología Barraquer, Barcelona

8036

Hospital Clinic de Barcelona (Hospital Clinic i Provincial), Barcelona

10800

MEDOKO s.r.o., Prague

15000

Axon clinical s.r.o., Prague

20014

Hospital Universitario Donostia, Oftalmalogia, Donostia / San Sebastian

20079

Samodzielny Publiczny Szpital Kliniczny Nr 1 Klinika Diagnostyki i Mikrochirurgii Jaskry Oddział Okulistyki, Lublin

20122

Universita degli Studi di Milano - Clinica Oculistica I, Milan

20123

Universita degli Studi di Milano - Ospedale San Giuseppe - Clinica Oculistica (University Eye Clinic), Milan

20142

ASST Santi Paolo e Carlo - Ospedale San Paolo Polo Universitario - Clinica Oculistica III, Milan

20157

Polo Universita degli Studi di Milano - Ospedale Luigi Sacco - Clinica Oculistica (Eye Clinic), Milan

27100

Universita degli Studi di Pavia - Fondazione IRCCS Policlinico San Matteo - Clinica Oculistic, Pavia

30644

Niepubliczny Zaklad Opieki Zdrowotnej Oko-Laser, Krakow

35100

Ege Universitesi Tip Fakultesi Hastanesi Goz Hastaliklari Anabilim Dali, Bornova

35128

Universita degli Studi di Padova - Azienda Ospedaliera di Padova - Clinica Oculistica, Padua

40594

Gabinet Okulistyczny Prof. Edward Wylęgała, Katowice

40952

Uniwersyteckie Centrum Kliniczne Śląskiego Uniwersytetu Medycznego w Katowicach, Katowice

41004

Saratov Railway Clinic, Saratov

41092

Cartujavision Oftalmologia, Seville

41505

Nemocnice Teplice, Ocni Oddeleni, Teplice

42130

Selcuk University School of Medicine Ophthalmology department, Konya

46015

Fundación Oftalmológica del Mediterráneo, Valencia

50005

University Hospital Hradec Kralove, Hradec Králové

50009

Hospital Clinico Universitario Lozano Blesa de Zaragoza, Zaragoza

50556

Uniwersytecki Szpital Kiliniczny IM. Jana Milkulicza-Radeckiego we Wroclawiu, Wroclaw

53002

Ocni klinika OFTEX, Pardubice

62500

Fakultní Nemocnice Brno, Brno

69317

Hospices Civils de Lyon - Hopital de la Croix-Rousse, Lyon

70800

Fakultni Nemocnice Ostrava, Oční Klinika, Ostrava

75012

Hôpital des Quinze-Vingts, Paris

75877

Hopitaux Universitaires Paris Nord Val de Seine - Hopital Bichat - Claude Bernard, Paris

94270

Hopitaux Universitaires Paris-Sud - Hopital Bicetre, Le Kremlin-Bicêtre

98128

Azienda Ospedaliera Universitaria Policlinico Gaetano Martino - Messina, Messina

111398

State Budget Educational Institution of High Professional Education Moscow State Medical Stomatology University named after A.I.Evdokimov of MoH of RF, Moscow

126486

NMRC ISTC Eye Microsurgery n. a. Fyodorov - Moscow, Moscow

153040

Ivanovo Regional Clinical Hospital, Ivanov

194100

Saint Petersburg State Pediatric Medical University, Saint Petersburg

197002

First Saint Petersburg State Medical University named after academician I.P. Pavlov, Saint Petersburg

428028

Federal State Institution Intersectoral Research and Technology Complex Eye microsurgery n.a. academician S.N. Fyodorov - Cheboksary, Cheboksary

630120

FSBI The Academician S.N. Fyodorov IRTC Eye Microsurgery of the Minzdrava - Novosibirsk, Novosibirsk

644024

GBOU VPO Omsk State Medical Academy, Ophthalmology Department, Omsk

All Listed Sponsors
lead

Santen SAS

INDUSTRY

NCT04144413 - 3-year Study in Dry Eye Disease Patients With Severe Keratitis Receiving Ikervis® (1mg/mL Ciclosporin) | Biotech Hunter | Biotech Hunter