Clinical trial NCT01751126: Double-Masked Trial of NOVA22007 (1mg/mL Ciclosporin/Cyclosporine) Versus Vehicle in Pediatric Patients With Active Severe Vernal Keratoconjunctivitis
Official title: A Multicenter, Randomized, Double-Masked, 3 Parallel Arms, Placebo Controlled Study to Assess the Efficacy and Safety of NOVA22007 1mg/mL (Ciclosporin/Cyclosporine) Eye Drops, Emulsion Administered in Paediatric Patients With Active Severe Vernal Keratoconjunctivitis With Severe Keratitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vernal Keratoconjunctivitis
Keywords: vernal keratoconjunctivitis
ciclosporin
cyclosporine
Lead sponsor: Santen SAS
Sponsor class: INDUSTRY
First posted: 2012-12-17
Enrollment: 169
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to compare the efficacy of two different dosing regimen of NOVA22007 (1mg/ml ciclosporin/cyclosporine) eye drops, emulsion versus placebo (vehicle of the formulation) administered four times a day in patients with severe vernal keratoconjunctivitis after 4 months of treatment.


Eligibility criteria: Inclusion Criteria:

* Males or females from 4 to less than 18 years of age.
* History of at least one recurrence of vernal keratoconjunctivitis (VKC) in the past year prior to enrolment.
* Patients not receiving any treatment for an established and active VKC; or patients already receiving treatment for their VKC provided treatment is stopped according to the wash-out period specified in the exclusion criteria.
* Active severe VKC consistent with grade 3 or 4 of Bonini scale (Bonini 2007) with severe keratitis (grade 4 or 5 on the modified Oxford scale).
* Mean score of 4 subjective symptoms (photophobia, tearing, itching and mucous discharge) ≥ 60 mm using a 100 mm Visual Analogue Scale (where "0" means no symptom and "100" means the worst that have been ever experienced).

Exclusion Criteria:

* Any relevant ocular anomaly other than VKC interfering with the ocular surface including trauma, post radiation keratitis, severe blepharitis, rosacea, corneal ulcer etc.
* Abnormal lid anatomy, abnormalities of the nasolacrimal drainage system or blinking function in either eye.
* Active herpes keratitis or history of ocular herpes.
* Active ocular infection (viral, bacterial, fungal, protozoal).
* Any ocular diseases other than VKC requiring topical ocular treatment during the course of the study.
* Contact lenses wear during the study.
* Topical and/or systemic use of corticosteroids within one week prior to enrolment.
* Topical ciclosporin (e.g. Restasis®), tacrolimus or sirolimus within 90 days prior to enrolment.
* Scraping of the vernal plaque within one month prior to the Baseline visit.
* Ocular surgery within 6 months prior to the Baseline visit (excluding surgical treatment of the vernal plaque).
* Disease not stabilized within 30 days before the Baseline Visit (e.g., diabetes with glycemia out of range, thyroid malfunction, uncontrolled autoimmune disease, current systemic infections) or judged by the investigator to be incompatible with the study.
* Presence or history of severe systemic allergy.
* Any systemic immunosuppressant drugs within 90 days before the Baseline Visit.
* Known hypersensitivity to one of the components of the study or procedural medications (e.g., fluorescein, etc).
* History of malignancy in the last 5 years.
* Pregnancy or lactation at the Baseline Visit.
* History of ocular varicella-zoster or vaccinia virus infection.

Primary outcomes:
measure: Average Penalties Adjusted Composite Efficacy Score (CFS) Score Over the 4 Months
timeFrame: over the 4 months
Secondary outcomes:
measure: Best Corrected Distance Visual Acuity (BCDVA) in 4-month Randomized Period I
timeFrame: Up to Month4
measure: Best Corrected Distance Visual Acuity (BCDVA) in 8-month Safety FU Period- Period II
timeFrame: Up to Month12
measure: Number of Courses of Rescue Medication in Period I
timeFrame: Up to Month4
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Glendale, CA, USA
state: California
city: Irvine
country: United States
facility: Irvine, CA, USA
state: California
city: Rancho Cordova
country: United States
facility: Rancho Cordova, CA, USA
state: California
city: Miami
country: United States
facility: Miami, FL, USA
state: Florida
city: Zagreb
country: Croatia
facility: Zagreb, City of Zagreb, HR
state: City Of Zagreb
city: Marseille
country: France
facility: Marseille, Bouches-du-Rhône, FR
state: Bouches-du-Rhône
city: Angers CEDEX 9
country: France
facility: Angers CEDEX 9, Maine-et-Loire, FR
state: Maine-et-Loire
city: Amiens CEDEX
country: France
facility: Amiens CEDEX, Somme, FR
state: Somme
city: Tours
country: France
facility: Tours CEDEX 9, FR
city: Paris CEDEX 8
country: France
facility: Paris CEDEX 8, Île-de-France, FR
state: Île-de-France
city: Mainz
country: Germany
facility: Mainz, Rhineland-Palatinate, DE
state: Rhineland-Palatinate
city: Ioannina
country: Greece
facility: Ioannina, Eprius, GR
state: Eprius
city: Thessaloniki
country: Greece
facility: Thessaloniki, Macedonia, GR
state: Macedonia
city: Larissa
country: Greece
facility: Larissa, Thessaly, GR
state: Thessaly
city: Szeged
country: Hungary
facility: Szeged, Csongrád, HU
state: Csongrád
city: Debrecen
country: Hungary
facility: Debrecen, Hajdú-Bihar, HU
state: Hajdú-Bihar
city: Budapest
country: Hungary
facility: Budapest, HU
city: Visakhapatnam
country: India
facility: Visakhapatnam, Andhra Pradesh, IN
state: Andhra Pradesh
city: New Delhi
country: India
facility: New Delhi, National Capitol Territory, IN
state: National Capitol Territory
city: Chennai
country: India
facility: Chennai, Tamil Nadu, IN
state: Tamil Nadu
city: Lucknow
country: India
facility: Lucknow, Uttar Pradesh, IN
state: Uttar Pradesh
city: Be'er-Sheva
country: Israel
facility: Be'er-Sheva, IL
city: Jerusalem
country: Israel
facility: Jerusalem, IL
city: Petah-Tikva
country: Israel
facility: Petah-Tikva, IL
city: Rehovot
country: Israel
facility: Rehovot, IL
city: Tel-Aviv
country: Israel
facility: Tel-Aviv, IL
city: Bologna
country: Italy
facility: Bologna, Emilia-Romagna, IT
state: Emilia-Romagna
city: Lavagna
country: Italy
facility: Lavagna, Liguria, IT
state: Liguria
city: Cinisello
country: Italy
facility: Cinisello, Pisa, IT
state: Pisa
city: Firenze
country: Italy
facility: Firenze, Tuscany, IT
state: Tuscany
city: Padova
country: Italy
facility: Padova, Veneto, IT
state: Veneto
city: Messina
country: Italy
facility: Messina, Messina, IT
city: Vila Nova de Gaia
country: Portugal
facility: Vila Nova de Gaia, Douro Litoral, PT
state: Douro Litoral
city: Lisboa
country: Portugal
facility: Lisboa, Extremadura, PT
state: Extremadura
city: Lisboa
country: Portugal
facility: Lisboa, Extremadura, PT
state: Extremadura
city: Torrevieja
country: Spain
facility: Torrevieja, Alicante, ES
state: Alicante
city: Barakaldo
country: Spain
facility: Barakaldo, Biscay, ES
state: Biscay
city: San Sebastián
country: Spain
facility: San Sebastián, Guipúzcoa, ES
state: Guipúzcoa
city: Aranjuez
country: Spain
facility: Aranjuez, Madrid, ES
state: Madrid
city: A Coruña
country: Spain
facility: A Coruña, A Coruña, ES
city: Alicante
country: Spain
facility: Alicante, Alicante, ES
city: Madrid
country: Spain
facility: Madrid, Madrid, ES
city: Madrid
country: Spain
facility: Madrid, Madrid, ES
city: Sevilla
country: Spain
facility: Sevilla, Sevilla, ES
city: Valencia
country: Spain
facility: Valencia, Valencia, ES
city: Valencia
country: Spain
facility: Valencia, Valencia, ES
Study officials:
References: