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    Summary
    EudraCT Number:2009-012446-23
    Sponsor's Protocol Code Number:192371-016
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-07-29
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2009-012446-23
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Masked, Parallel-Group Study Evaluating the Efficacy and Safety of Cyclosporine Ophthalmic Solution 0.010% Compared with its Vehicle Administered QID for 3 months Followed by a 9 Month Open-Label Phase in Patients with Atopic Keratoconjunctivitis.

    Estudio multicéntrico, aleatorizado, doble ciego, de grupos paralelos para evaluar la eficacia y seguridad de Ciclosporina Solución oftálmica 0,010% en comparación con su vehículo administrada cuatro veces al día durante 3 meses, seguido de una fase abierta de 9 meses en pacientes con queratoconjuntivitis atópica.
    A.4.1Sponsor's protocol code number192371-016
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAllergan Limited
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCiclosporin 0.01% Ophthalmic Solution
    D.3.2Product code 9917X
    D.3.4Pharmaceutical form Eye drops, solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOcular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCiclosporin
    D.3.9.1CAS number 059865-13-3
    D.3.9.2Current sponsor codeAGN-192371
    D.3.9.3Other descriptive nameCiclosporin A
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.010
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboEye drops, solution
    D.8.4Route of administration of the placeboOcular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Atopic Keratoconjunctivitis (AKC)

    Queratoconjuntivitis atópica (QCA)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10023348
    E.1.2Term Keratoconjunctivitis
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy and safety of COS 0.010% compared to its vehicle in the treatment of Atopic Keratoconjunctivitis (AKC).
    E.2.2Secondary objectives of the trial
    N/A
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female patients at least 12 years of age
    - Female of childbearing potential must use a reliable form of contraception throughout the study period.
    - A negative urine pregnancy test result at Screening (Day -14) and Baseline (Day 1) for women of childbearing potential.
    - Best-corrected Visual Acuity of 20/800 or better in both eyes.
    - Written informed consent has been obtained.
    - Written Data Protection Consent has been obtained.
    - Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable.
    - Ability to follow study instructions and likely to complete all required study visits.
    - Clinical diagnosis of AKC, in which each of the following have been documented in the ophthalmic and medical histories (each ophthalmic sign could have been present in either eye):
    Chronic blepharoconjunctivitis
    Bulbar conjunctival hyperemia
    Punctuate keratitis (punctuate corneal staining)
    Presence or documented history of upper tarsal papillary hypertrophy
    Presence or documented history of atopic dermatitis
    - Presence of all the following in the same eye for at least one eye:
    At least Grade 2 punctuate corneal staining on a scale of 0-5
    At least Grade 1 bulbar conjunctival hyperemia on a scale of 0-3
    A composite symptom score of at least 4 or more (The composite symptom score is the sum of the severity scores for Itching, Tearing, Ocular Discomfort, Photophobia, and Mucous Discharge scored on a scale of 0-3 with a composite range of 0-15.)
    - At least one of the following in the same eye meeting inclusion criteria #11:
    Stable doses of topical ophthalmic steroid for treatment of AKC during the 2 weeks prior to Baseline (Day 1)
    Or,
    Patient has required at least 4 weeks of steroid to treat any previous exacerbation of AKC
    Or,
    History of intolerance to topical ophthalmic steroid use (e.g., hypersensitivity, steroid response glaucoma).
    - Stable doses of topical ophthalmic or systemic mast cell stabilizers, antihistamines, NSAIDs, or any combination of these medications are allowed if on stable doses for 2 weeks prior to Baseline (Day 1) in the eligible eye.
    - Stable doses of topical calcineurin inhibitors (e.g. topical tacrolimus or topical pimecrolimus) for dermatological use are allowed if on stable doses for 4 weeks prior to Baseline (Day 1). However, they are not allowed on the ocular surface or ocular adnexa including eyelids.
    - Stable doses of systemic immunosuppressives or systemic steroids are allowed if on stable doses for 4 weeks prior to Baseline (Day 1) except those meeting Exclusion Criteria 4. Adjustments to nasal or inhaled steroids are allowed during the screening period.
    E.4Principal exclusion criteria
    - Uncontrolled systemic disease (except for atopic dermatitis)
    - Female patients who are pregnant, nursing, or planning a pregnancy during the study
    - Use of contact lenses within 48 hours prior to Baseline (Day 1) or anticipated use of contact lenses during the study in either eye
    - Use of systemic or topical ophthalmic ciclosporin, systemic or topical ophthalmic tacrolimus, topical ophthalmic pimecrolimus (e.g., topical ophthalmic ciclosporin, tacrolimus, or pimecrolimus formulations prepared by pharmacists), or systemic sirolimus within 4 weeks prior to Baseline (Day 1) or anticipated use during the study in either eye
    - Use of topical calcineurin inhibitors (e.g. topical tacrolimus or topical pimecrolimus) on the ocular surface or ocular adnexa including eyelids within 4 weeks prior to Baseline (Day 1) or anticipated use during the study in either eye
    - Current enrollment in an investigational drug or device study or participation in such within 30 days prior to entry into this study
    - Known allergy or sensitivity to the study medication(s) or its components
    - Anticipated use of glaucoma medications or other chronic topical ophthalmic medications (except artificial tears and those meeting Inclusion Criteria 12, 13 or 14)
    - History of inflammatory corneal ulcers not related to AKC, herpetic keratitis, recent or recurrent uveitis, or other severe or serious ocular pathology or other medical condition in either eye that could result in the patient?s inability to safely complete the study.
    - Active ocular disease not related to AKC, (e.g., infectious corneal ulcers, herpetic keratitis, uveitis, or ocular infection) in either eye
    - Patient has a situation or condition, which in the investigator?s opinion, may put the patient at a significant risk, may confound the study result or may interfere significantly with the participation in the study.
    E.5 End points
    E.5.1Primary end point(s)
    - Punctuate corneal staining score responders (defined as the proportion of patients with a 2 or more grade improvement in punctuate corneal staining)
    - Composite symptom score responders (defined as the proportion of patients with a 4 or more grade improvement in composite symptom score)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last subject last visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    For subjects between 12 and 17 years, parents or guardians will be given adult patient information sheet and consent form to consent the subject. Assent forms will be provided according to the particular individual?s level of understanding.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 124
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    The study doctor will discuss with the patient the best treatment available at the end of the study. Ciclosporin Ophthalmic Solution 0.010% is not anticipated to be provided as compassionate use at the end of the study.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2009-10-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-09-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-07-29
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