Double-Masked Trial of NOVA22007 (1mg/mL Ciclosporin/Cyclosporine) Versus Vehicle in Pediatric Patients With Active Severe Vernal Keratoconjunctivitis

PHASE3CompletedINTERVENTIONAL
Enrollment

169

Participants

Timeline

Start Date

April 29, 2013

Primary Completion Date

February 29, 2016

Study Completion Date

February 29, 2016

Conditions
Vernal Keratoconjunctivitis
Interventions
DRUG

NOVA22007 ''Ciclosporin''

Sterile, ophthalmic cationic oil-in-water emulsion containing 1 mg/ml Ciclosporin.

DRUG

Placebo

Sterile, drug-free, cationic ophthalmic oil-in-water emulsion containing 0 mg/ml Ciclosporin.

Trial Locations (46)

10000

Zagreb, City of Zagreb, HR, Zagreb

13008

Marseille, Bouches-du-Rhône, FR, Marseille

15006

A Coruña, A Coruña, ES, A Coruña

16033

Lavagna, Liguria, IT, Lavagna

20014

San Sebastián, Guipúzcoa, ES, San Sebastián

28009

Madrid, Madrid, ES, Madrid

28046

Madrid, Madrid, ES, Madrid

28300

Aranjuez, Madrid, ES, Aranjuez

33136

Miami, FL, USA, Miami

35128

Padova, Veneto, IT, Padua

37044

Tours CEDEX 9, FR, Tours

40138

Bologna, Emilia-Romagna, IT, Bologna

41003

Sevilla, Sevilla, ES, Seville

41110

Larissa, Thessaly, GR, Larissa

45500

Ioannina, Eprius, GR, Ioannina

46014

Valencia, Valencia, ES, Valencia

46015

Valencia, Valencia, ES, Valencia

48903

Barakaldo, Biscay, ES, Barakaldo

49100

Petah-Tikva, IL, Petah Tikva

49933

Angers CEDEX 9, Maine-et-Loire, FR, Angers

50139

Firenze, Tuscany, IT, Florence

54636

Thessaloniki, Macedonia, GR, Thessaloniki

55131

Mainz, Rhineland-Palatinate, DE, Mainz

56124

Cinisello, Pisa, IT, Cinisello Balsamo

64239

Tel-Aviv, IL, Tel Aviv

75877

Paris CEDEX 8, Île-de-France, FR, Paris

76100

Rehovot, IL, Rehovot

80054

Amiens CEDEX, Somme, FR, Amiens

84101

Be'er-Sheva, IL, Beersheba

91120

Jerusalem, IL, Jerusalem

91204

Glendale, CA, USA, Glendale

92697

Irvine, CA, USA, Irvine

95670

Rancho Cordova, CA, USA, Rancho Cordova

98125

Messina, Messina, IT, Messina

110002

New Delhi, National Capitol Territory, IN, New Delhi

226003

Lucknow, Uttar Pradesh, IN, Lucknow

530013

Visakhapatnam, Andhra Pradesh, IN, Visakhapatnam

600006

Chennai, Tamil Nadu, IN, Chennai

H-6720

Szeged, Csongrád, HU, Szeged

H-4031

Debrecen, Hajdú-Bihar, HU, Debrecen

H-1085

Budapest, HU, Budapest

4434-502

Vila Nova de Gaia, Douro Litoral, PT, Vila Nova de Gaia

1150-199

Lisboa, Extremadura, PT, Lisbon

1169-019

Lisboa, Extremadura, PT, Lisbon

03186

Torrevieja, Alicante, ES, Torrevieja

03016

Alicante, Alicante, ES, Alicante

All Listed Sponsors
lead

Santen SAS

INDUSTRY

NCT01751126 - Double-Masked Trial of NOVA22007 (1mg/mL Ciclosporin/Cyclosporine) Versus Vehicle in Pediatric Patients With Active Severe Vernal Keratoconjunctivitis | Biotech Hunter | Biotech Hunter