- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01751126
Double-Masked Trial of NOVA22007 (1mg/mL Ciclosporin/Cyclosporine) Versus Vehicle in Pediatric Patients With Active Severe Vernal Keratoconjunctivitis
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
City Of Zagreb
-
Zagreb, City Of Zagreb, Croatia, 10000
- Zagreb, City of Zagreb, HR
-
-
-
-
-
Tours, France, 37044
- Tours CEDEX 9, FR
-
-
Bouches-du-Rhône
-
Marseille, Bouches-du-Rhône, France, 13008
- Marseille, Bouches-du-Rhône, FR
-
-
Maine-et-Loire
-
Angers CEDEX 9, Maine-et-Loire, France, 49933
- Angers CEDEX 9, Maine-et-Loire, FR
-
-
Somme
-
Amiens CEDEX, Somme, France, 80054
- Amiens CEDEX, Somme, FR
-
-
Île-de-France
-
Paris CEDEX 8, Île-de-France, France, 75877
- Paris CEDEX 8, Île-de-France, FR
-
-
-
-
Rhineland-Palatinate
-
Mainz, Rhineland-Palatinate, Germany, 55131
- Mainz, Rhineland-Palatinate, DE
-
-
-
-
Eprius
-
Ioannina, Eprius, Greece, 45500
- Ioannina, Eprius, GR
-
-
Macedonia
-
Thessaloniki, Macedonia, Greece, 54636
- Thessaloniki, Macedonia, GR
-
-
Thessaly
-
Larissa, Thessaly, Greece, 41110
- Larissa, Thessaly, GR
-
-
-
-
-
Budapest, Hungary, H-1085
- Budapest, HU
-
-
Csongrád
-
Szeged, Csongrád, Hungary, H-6720
- Szeged, Csongrád, HU
-
-
Hajdú-Bihar
-
Debrecen, Hajdú-Bihar, Hungary, H-4031
- Debrecen, Hajdú-Bihar, HU
-
-
-
-
Andhra Pradesh
-
Visakhapatnam, Andhra Pradesh, India, 530013
- Visakhapatnam, Andhra Pradesh, IN
-
-
National Capitol Territory
-
New Delhi, National Capitol Territory, India, 110002
- New Delhi, National Capitol Territory, IN
-
-
Tamil Nadu
-
Chennai, Tamil Nadu, India, 600006
- Chennai, Tamil Nadu, IN
-
-
Uttar Pradesh
-
Lucknow, Uttar Pradesh, India, 226003
- Lucknow, Uttar Pradesh, IN
-
-
-
-
-
Be'er-Sheva, Israel, 84101
- Be'er-Sheva, IL
-
Jerusalem, Israel, 91120
- Jerusalem, IL
-
Petah-Tikva, Israel, 49100
- Petah-Tikva, IL
-
Rehovot, Israel, 76100
- Rehovot, IL
-
Tel-Aviv, Israel, 64239
- Tel-Aviv, IL
-
-
-
-
-
Messina, Italy, 98125
- Messina, Messina, IT
-
-
Emilia-Romagna
-
Bologna, Emilia-Romagna, Italy, 40138
- Bologna, Emilia-Romagna, IT
-
-
Liguria
-
Lavagna, Liguria, Italy, 16033
- Lavagna, Liguria, IT
-
-
Pisa
-
Cinisello, Pisa, Italy, 56124
- Cinisello, Pisa, IT
-
-
Tuscany
-
Firenze, Tuscany, Italy, 50139
- Firenze, Tuscany, IT
-
-
Veneto
-
Padova, Veneto, Italy, 35128
- Padova, Veneto, IT
-
-
-
-
Douro Litoral
-
Vila Nova de Gaia, Douro Litoral, Portugal, 4434-502
- Vila Nova de Gaia, Douro Litoral, PT
-
-
Extremadura
-
Lisboa, Extremadura, Portugal, 1150-199
- Lisboa, Extremadura, PT
-
Lisboa, Extremadura, Portugal, 1169-019
- Lisboa, Extremadura, PT
-
-
-
-
-
A Coruña, Spain, 15006
- A Coruña, A Coruña, ES
-
Alicante, Spain, 03016
- Alicante, Alicante, ES
-
Madrid, Spain, 28009
- Madrid, Madrid, ES
-
Madrid, Spain, 28046
- Madrid, Madrid, ES
-
Sevilla, Spain, 41003
- Sevilla, Sevilla, ES
-
Valencia, Spain, 46014
- Valencia, Valencia, ES
-
Valencia, Spain, 46015
- Valencia, Valencia, ES
-
-
Alicante
-
Torrevieja, Alicante, Spain, 03186
- Torrevieja, Alicante, ES
-
-
Biscay
-
Barakaldo, Biscay, Spain, 48903
- Barakaldo, Biscay, ES
-
-
Guipúzcoa
-
San Sebastián, Guipúzcoa, Spain, 20014
- San Sebastián, Guipúzcoa, ES
-
-
Madrid
-
Aranjuez, Madrid, Spain, 28300
- Aranjuez, Madrid, ES
-
-
-
-
California
-
Glendale, California, United States, 91204
- Glendale, CA, USA
-
Irvine, California, United States, 92697
- Irvine, CA, USA
-
Rancho Cordova, California, United States, 95670
- Rancho Cordova, CA, USA
-
-
Florida
-
Miami, Florida, United States, 33136
- Miami, FL, USA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ciclosporin
One drop of ciclosporin (NOVA22007) 1 mg/ml 4 times a day as monotherapy (morning, noon, afternoon and evening).
|
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.
|
Sterile, ophthalmic cationic oil-in-water emulsion containing 1 mg/ml Ciclosporin.
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).
|
Sterile, drug-free, cationic ophthalmic oil-in-water emulsion containing 0 mg/ml Ciclosporin.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Average Penalties Adjusted Composite Efficacy Score (CFS) Score Over the 4 Months
Time Frame: over the 4 months
|
Efficacy was assessed every month during the 4-month treatment phase and compared with Baseline using a composite criterion based on:
An efficacy score was calculated as follows: Patient's score at month X = CFS (Baseline) - CFS (Month X) + penalty (ies) Penalty for rescue medication: -1 (per course, with a maximum of 2 courses between 2 scheduled visits) Penalty for corneal ulceration: -1 (per occurrence). A positive value indicated improvement. The maximum CFS is five and the minimum cannot be set due to the number of rescue medication and ulceration which decreases the penalty adjusted CFS. |
over the 4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Best Corrected Distance Visual Acuity (BCDVA) in 4-month Randomized Period I
Time Frame: Up to Month4
|
Best corrected distance visual acuity (BCDVA) was measured with the patient's best correction and recorded in LogMAR (log of the Minimum Angle of Resolution) A negative LogMar BCDVA measure shows an improvement, whereas positive values indicates poor vision.
|
Up to Month4
|
Best Corrected Distance Visual Acuity (BCDVA) in 8-month Safety FU Period- Period II
Time Frame: Up to Month12
|
Best corrected distance visual acuity (BCDVA) was measured with the patient's best correction and recorded in LogMAR (log of the Minimum Angle of Resolution) A negative LogMar BCDVA measure shows an improvement, whereas positive values indicate poor vision.
|
Up to Month12
|
Number of Courses of Rescue Medication in Period I
Time Frame: Up to Month4
|
Use of rescue medication: the total number of topical corticosteroid courses was assessed at each visit during the 4-month efficacy evaluation treatment period.
|
Up to Month4
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Hypersensitivity, Immediate
- Eye Diseases
- Hypersensitivity
- Conjunctivitis
- Conjunctival Diseases
- Keratitis
- Corneal Diseases
- Conjunctivitis, Allergic
- Keratoconjunctivitis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antirheumatic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Dermatologic Agents
- Antifungal Agents
- Calcineurin Inhibitors
- Cyclosporine
- Cyclosporins
Other Study ID Numbers
- NVG09B113
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Vernal Keratoconjunctivitis
-
Laboratoires TheaCompletedKeratoconjunctivitis, Vernal
-
Santen SASCompletedConjunctivitis, VernalFrance
-
Fondazione IRCCS Ca' Granda, Ospedale Maggiore...Completed
-
National Taiwan University HospitalUnknownTacrolimus | Vernal Keratoconjunctivitis | Atopic KeratoconjunctivitisTaiwan
-
Astellas Pharma IncCompletedKeratoconjunctivitis | ConjunctivitisJapan
-
Siriraj HospitalCompletedKeratoconjunctivitis, VernalThailand
-
Astellas Pharma IncCompletedKeratoconjunctivitis | ConjunctivitisJapan
-
Campus Bio-Medico UniversityUniversity of Padova; University of GenovaCompletedVernal KeratoconjunctivitisItaly
-
Allakos Inc.CompletedVernal Keratoconjunctivitis | Perennial Allergic Conjunctivitis | Atopic KeratoconjunctivitisUnited States
-
Fondation Ophtalmologique Adolphe de RothschildCompletedVernal KeratoconjunctivitisFrance
Clinical Trials on NOVA22007 ''Ciclosporin''
-
Santen SASCompletedModerate to Severe Dry Eye SyndromeFrance
-
Santen SASCompletedConjunctivitis, VernalFrance
-
Jiangsu HengRui Medicine Co., Ltd.Recruiting
-
Maruho Europe LimitedCompleted
-
NeuroVive Pharmaceutical ABCompleted
-
Santen SASCompletedDry EyeUnited States
-
Imperial College LondonMedical Research Council; Imperial College Healthcare NHS Trust; University Hospital...CompletedHTLV I Associated MyelopathyUnited Kingdom
-
Novartis PharmaceuticalsCompletedSevere Atopic Dermatitis
-
PerioC LimitedCompleted
-
Novartis PharmaceuticalsCompletedSevere Atopic Dermatitis