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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Novagali Pharma
Sponsor:
Information provided by (Responsible Party):
Novagali Pharma
ClinicalTrials.gov Identifier:
NCT01751126
First received: December 13, 2012
Last updated: April 25, 2014
Last verified: April 2014
  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:


Further study details as provided by Novagali Pharma:

Primary Outcome Measures:
  • Compare the composite efficacy score over 4 months of treatment base on keratitis and need for rescue medication for two different dosing regimens of NOVA22007 versus placebo (vehicle of the formulation). [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tolerability of will be assessed monthly through slit lamp examination, BCDVA, IOP and safety through vital signs, AE reporting, CsA blood levels and biological tests. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • The main secondary endpoints are the assessment of the corneal keratitis, the use of rescue therapy and the occurrence of ulcer which will be assessed monthly. [ 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.
  • History of ocular varicella-zoster or vaccinia virus infection.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
Glendale, CA, USA Recruiting
Glendale, California, United States, 91204
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Irvine, CA, USA Recruiting
Irvine, California, United States, 92697
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Rancho Cordova, CA, USA Recruiting
Rancho Cordova, California, United States, 95670
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France
Marseille, Bouches-du-Rhône, FR Recruiting
Marseille, Bouches-du-Rhône, France, 13008
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Angers CEDEX 9, Maine-et-Loire, FR Recruiting
Angers CEDEX 9, Maine-et-Loire, France, 49933
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Amiens CEDEX, Somme, FR Recruiting
Amiens CEDEX, Somme, France, 80054
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Tours CEDEX 9, FR Recruiting
Tours, France, 37044
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Paris CEDEX 8, Île-de-France, FR Recruiting
Paris CEDEX 8, Île-de-France, France, 75877
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Hungary
Szeged, Csongrád, HU Recruiting
Szeged, Csongrád, Hungary, H-6720
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Debrecen, Hajdú-Bihar, HU Recruiting
Debrecen, Hajdú-Bihar, Hungary, H-4031
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Budapest, HU Recruiting
Budapest, Hungary, H-1085
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Israel
Be'er-Sheva, IL Recruiting
Be'er-Sheva, Israel, 84101
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Jerusalem, IL Recruiting
Jerusalem, Israel, 91120
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Petah-Tikva, IL Recruiting
Petah-Tikva, Israel, 49100
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Rehovot, IL Recruiting
Rehovot, Israel, 76100
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Tel-Aviv, IL Recruiting
Tel-Aviv, Israel, 64239
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Italy
Bologna, Emilia-Romagna, IT Recruiting
Bologna, Emilia-Romagna, Italy, 40138
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Lavagna, Liguria, IT Recruiting
Lavagna, Liguria, Italy, 16033
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Firenze, Tuscany, IT Recruiting
Firenze, Tuscany, Italy, 50139
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Padova, Veneto, IT Recruiting
Padova, Veneto, Italy, 35128
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Portugal
Vila Nova de Gaia, Douro Litoral, PT Recruiting
Vila Nova de Gaia, Douro Litoral, Portugal, 4434-502
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Lisboa, Extremadura, PT Recruiting
Lisboa, Extremadura, Portugal, 1500-473
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Lisboa, Extremadura, PT Recruiting
Lisboa, Extremadura, Portugal, 1169-019
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Lisboa, Extremadura, PT Recruiting
Lisboa, Extremadura, Portugal, 1150-199
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Spain
Torrevieja, Alicante, ES Recruiting
Torrevieja, Alicante, Spain, 03186
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Barakaldo, Biscay, ES Recruiting
Barakaldo, Biscay, Spain, 48903
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San Sebastián, Guipúzcoa, ES Recruiting
San Sebastián, Guipúzcoa, Spain, 20014
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Aranjuez, Madrid, ES Recruiting
Aranjuez, Madrid, Spain, 28300
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A Coruña, A Coruña, ES Recruiting
A Coruña, Spain, 15006
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Alicante, Alicante, ES Recruiting
Alicante, Spain, 03016
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Madrid, Madrid, ES Recruiting
Madrid, Spain, 28046
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Madrid, Madrid, ES Recruiting
Madrid, Spain, 28009
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Sevilla, Sevilla, ES Recruiting
Sevilla, Spain, 41003
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Valencia, Valencia, ES Recruiting
Valencia, Spain, 46014
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Valencia, Valencia, ES Recruiting
Valencia, Spain, 46015
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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: April 25, 2014
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 July 23, 2014