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

Purpose

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.

Condition	Intervention	Phase
Vernal Keratoconjunctivitis	Drug: NOVA22007 ''Ciclosporin'' Drug: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: keratitis-ichthyosis-deafness syndrome

Drug Information available for: Cyclosporine

U.S. FDA Resources

Further study details as provided by Novagali Pharma:

Primary Outcome Measures:

Compare the efficacy of two different dosing regimens of NOVA22007 versus placebo (vehicle of the formulation) on both the evolution of severe keratitis and the need for rescue medication. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assess the safety and tolerability including ocular tolerance of 2 dosing regimens of NOVA22007 versus placebo. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Assess the efficacy of 2 dosing regimens of NOVA22007 versus placebo on other signs and symptoms of vernal keratoconjunctivitis not covered in the primary objective. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	168
Study Start Date:	March 2013
Estimated Study Completion Date:	July 2014
Estimated Primary Completion Date:	July 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Ciclosporin One drop of ciclosporin (NOVA22007) 1 mg/ml 4 times a day as monotherapy (morning, noon, afternoon and evening).	Drug: NOVA22007 ''Ciclosporin'' Sterile, ophthalmic cationic oil-in-water emulsion containing 1 mg/ml Ciclosporin.
Experimental: Ciclosporin/Placebo One drop of ciclosporin (NOVA22007) 1 mg/ml twice a day and one drop of placebo twice a day (active study treatment morning and evening and placebo noon and afternoon) as monotherapy.	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.
Placebo Comparator: Placebo One drop of placebo 4 times a day as monotherapy (morning, noon, afternoon and evening).	Drug: Placebo Sterile, drug-free, cationic ophthalmic oil-in-water emulsion containing 0 mg/ml Ciclosporin.

Eligibility

Ages Eligible for Study:	4 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01751126

Contacts

Contact: Mourad Amrane, MD

+33 (0)1 69 87 40 20

mourad.amrane@novagali.com

Sponsors and Collaborators

Novagali Pharma

More Information

No publications provided

Responsible Party:	Novagali Pharma
ClinicalTrials.gov Identifier:	NCT01751126 History of Changes
Other Study ID Numbers:	NVG09B113
Study First Received:	December 13, 2012
Last Updated:	December 13, 2012
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Hungary: National Institute of Pharmacy Italy: The Italian Medicines Agency India: Drugs Controller General of India Israel: Ministry of Health Portugal: National Pharmacy and Medicines Institute Singapore: Health Sciences Authority Spain: Agencia Española de Medicamentos y Productos Sanitarios Turkey: Ministry of Health United States: Food and Drug Administration

Keywords provided by Novagali Pharma:

vernal keratoconjunctivitis
ciclosporin
cyclosporine

Additional relevant MeSH terms:

Keratoconjunctivitis
Conjunctivitis, Allergic
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Cyclosporins
Cyclosporine

Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 21, 2013