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    Summary
    EudraCT Number:2011-003278-10
    Sponsor's Protocol Code Number:192024-056
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2011-09-30
    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 ConcernedFrance - ANSM
    A.2EudraCT number2011-003278-10
    A.3Full title of the trial
    A Multicenter, Double-masked, Randomized, Active-controlled, Parallel Study of the Safety and Efficacy of Once-daily Bimatoprost Preservative-free Ophthalmic Solution Compared to Twice-daily Timolol Ophthalmic Solution in Paediatric Patients With Glaucoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study assessing the safety and efficacy of the study drug (Once-daily Bimatoprost Preservative-free Ophthalmic Solution) compared to Twice-daily Timolol Ophthalmic Solution (an already approved drug) in paediatric patients with glaucoma (an eye disorder in which the nerve to the eye suffers damage)
    A.3.2Name or abbreviated title of the trial where available
    Bimatoprost 0.03% Preservative-free Ophthalmic Solution in Paediatric Glaucoma
    A.4.1Sponsor's protocol code number192024-056
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/56/2011
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAllergan Ltd.
    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 supportAllergan Inc.
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportAllergan Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAllergan Limited
    B.5.2Functional name of contact pointAllergan Limited EU Regulatory Dept
    B.5.3 Address:
    B.5.3.1Street Address1st Floor, Marlow International, The Parkway
    B.5.3.2Town/ cityMarlow, Bucks
    B.5.3.3Post codeSL7 1YL
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 1628 494444
    B.5.5Fax number+44 1628 494449
    B.5.6E-mailml-eu_reg_affairs@allergan.com
    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 nameBimatoprost 0.03% PF ophthalmic solution
    D.3.2Product code 10037X
    D.3.4Pharmaceutical form Eye drops, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOcular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 155206-00-1
    D.3.9.2Current sponsor code10037X
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.3
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Timolol
    D.2.1.1.2Name of the Marketing Authorisation holderPacific Pharma
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameTimolol
    D.3.4Pharmaceutical form Eye drops, solution
    D.3.4.1Specific paediatric formulation No
    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 INNTIMOLOL MALEATE
    D.3.9.1CAS number 26921-17-5
    D.3.9.2Current sponsor code8771X
    D.3.9.4EV Substance CodeSUB04875MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Timolol
    D.2.1.1.2Name of the Marketing Authorisation holderPacific Pharma
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameTimolol
    D.3.4Pharmaceutical form Eye drops, solution
    D.3.4.1Specific paediatric formulation No
    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 INNTIMOLOL MALEATE
    D.3.9.1CAS number 26921-17-5
    D.3.9.2Current sponsor code8770X
    D.3.9.4EV Substance CodeSUB04875MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5.0
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    Glaucoma
    E.1.1.1Medical condition in easily understood language
    An eye disorder that occurs if increased pressure of the fluid in the eye builds up causing damage to the optic nerve. This can permanently damage vision and progress to blindness if untreated.
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10018304
    E.1.2Term Glaucoma
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the safety and intraocular pressure (IOP)-lowering efficacy of once-daily bimatoprost 0.03% preservative-free (PF) ophthalmic solution compared with twice-daily timolol (0.5% or 0.25%, based on age group) ophthalmic solution for 12 weeks in paediatric patients with glaucoma.
    E.2.2Secondary objectives of the trial
    N/A
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female patients, 2 months (age adjusted for prematurity, if applicable, for children younger than 1 year postnatal) to < 18 years of age at the baseline (day -1) visit (To adjust for prematurity, subtract the infant’s gestational age in weeks from 40 and then subtract this from the child’s postnatal age in weeks.)
    2. Written parental/legal guardian consent and minor assent (if applicable) has been obtained in accordance with any applicable state and local laws/regulations. At IRB/IEC’s discretion, a minor’s oral assent my be obtained in lieu of a written assent.
    3. Written documentation for use of health information has been obtained in accordance with the relevant country and local privacy requirements, where applicable (eg, Allergan’s Authorization for Use and Disclosure of Protected Health Information, or its equivalent, and Research Study Information [US sites] and written Data Protection consent [European Union sites]).
    4. Good general health as determined by the investigator from medical history and physical examination
    5. Patient has been diagnosed by an ophthalmologist to have congenital, juvenile, primary or secondary (except as excluded in Section 4.4 of the protocol), aphakic or pseudophakic glaucoma, requiring IOP lowering therapy in one or both eyes.
    6. Based on the patient’s medical history and the investigator’s opinion, IOP is likely to be controlled for the next 12 weeks (after baseline) by a single IOP-lowering topical ophthalmic medication.
    7. Patient can go without IOP-lowering therapy from 4 days to 2 weeks, without significant risk to the patient.
    8. Ability of patient and/or parent(s)/legal guardian(s) to follow study instructions and willingness to complete all required procedures and visits
    9. Baseline: Females of childbearing potential (ie, post-menarche) must have a urine pregnancy test result confirmed as negative prior to the start of treatment on day 1.
    10. Baseline: For patients able to perform recognition acuity, a best corrected visual acuity score equivalent to a Snellen acuity of 20/100 or better in each eye, using a logarithmic letter visual acuity chart, LEA symbol chart, or Allen pictures. For preverbal patients or patients who may be unable to be tested using standard methodology, patient must be able to at least fixate on and briefly follow an object
    (eg, small toy, “fix and follow”)
    11. Baseline (morning): IOP ≥ 22 mm Hg and ≤ 36 mm Hg in one or both eyes
    12. Baseline: Patient has been appropriately washed out of all IOP lowering medications in each eye.
    E.4Principal exclusion criteria
    1. Uncontrolled systemic disease
    2. Contraindications to beta-adrenoceptor antagonist therapy such as chronic obstructive pulmonary disease, bronchial asthma, history of bronchial asthma, sinus bradycardia, second and third degree atrioventricular block, overt cardiac failure or cardiogenic shock or uncontrolled congestive heart failure. Clearance for participation in the study from the patient’s primary paediatrician or primary care physician must be documented for all patients.
    3. Clinically relevant low or high blood pressure or pulse rate for age as determined by the investigator
    4. Females who are pregnant, nursing, or planning a pregnancy or who are of childbearing potential not using a reliable means of contraception throughout the study
    5. Abnormally low body weight for age (below 5th percentile)
    6. Patients in whom surgical intervention is indicated or anticipated for IOP lowering within 12 weeks after baseline. Note: Patients with primary congenital glaucoma will be excluded from the study unless surgery has already been performed.
    7. Patients with lens-induced glaucoma, steroid-induced glaucoma, or retinoblastoma
    8. Patients with secondary angle closure glaucoma due to anatomical abnormalities
    9. Patients with secondary glaucoma associated with increased episcleral pressure (eg, Sturge-Weber, cavernous fistula, orbital disease)
    10. Any other active or recurrent ocular disease (eg, iritis, uveitis, ocular infection, chronic moderate to severe blepharitis or severe dry eye, ocular seasonal allergies, diabetic retinopathy) in either eye that would interfere with the interpretation of the study data. However, ocular conditions of myopia, hyperopia, and strabismus (excluding cases where surgery is planned within the next 12 weeks) are allowed.
    11. History or evidence of severe ocular trauma in either eye
    12. Corneal or other ocular abnormalities (eg, bullous keratopathy, refractive surgery, corneal graft) that would preclude accurate readings with either Goldmann applanation tonometer or a hand-held tonometer. Note: A well-healed corneal scar or Haab’s striae will not exclude a patient.
    13. Any ocular anterior segment (including glaucoma) surgery in the study eye(s) within 3 months prior to baseline
    14. Patients who have had a cyclodestructive procedure
    15. Known allergy or sensitivity to the study medication(s) or their components
    16. Known allergy or contraindication to use of fluorescein
    17. Contraindication to pupil dilation
    18. Required chronic use of other ocular medications (post-screening visit) during the study. Note: Occasional use of artificial tear products is allowed but not within 24 hours prior to a scheduled visit through the week 12 visit.
    19. Current enrollment in an investigational drug or device study or participation in such a study at or past the screening visit, or within 30 days prior to the baseline (day -1) visit
    20. For patients with visual field test records, visual field loss that in the opinion of the investigator is functionally significant, or evidence of progressive visual field loss within the year prior to baseline (day -1)
    21. Patient’s IOP was previously uncontrolled on bimatoprost or timolol monotherapy
    22. Intermittent use of oral, intramuscular, or intravenous corticosteroids within 21 days prior to baseline or anticipated use within 21 days prior to a postbaseline study visit through the week 12
    23. Use of topical ophthalmic corticosteroids from 2 months prior to the screening visit through the week 12 visit
    24. Anticipated use of contact lenses during the study through the week 12 visit (use of soft lenses should be discontinued at least 24 hours prior to baseline, and use of rigid gas permeable or hard contact lenses should be discontinued at least 1 week prior to baseline)
    25. Introduction or anticipated alteration of existing chronic systemic medications (topical or injection) that may have a substantial effect on IOP from 2 months prior to screening visit through the week 12 visit
    26. Use or anticipated use of systemic beta-blocker medication from 2 months prior to screening visit through the week 12 visit
    27. Patient has a condition or is in a situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient’s participation in the study.
    28. In the judgment of the investigator, patient is unwilling or unable to cooperate for study-related procedures, including IOP measurement and biomicroscopic examination.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline (follow-up minus baseline) in the study eye IOP at week 12 (hour 2) is the primary efficacy variable. Note that a negative change from baseline indicates an IOP-lowering effect.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12 (hour 2)
    E.5.2Secondary end point(s)
    The secondary variable is IOP response. A patient is considered to be an IOP responder if he/she demonstrates at least a 15% reduction from baseline study eye IOP at week 12 (hour 2). Patients who received escape medication for the study eye prior to the week 12 visit will be classified as non-responders.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 12 (hour 2)
    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 Yes
    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 No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Brazil
    Canada
    France
    Germany
    Italy
    Korea, Republic of
    Philippines
    Spain
    Taiwan
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    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 Patient, 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 months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 84
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 4
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 46
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 34
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 54
    F.4.2.2In the whole clinical trial 84
    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)
    Patients will return to their standard clinical care as prescribed by their doctor once they finish participation in the study.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Medicines for Children Research Network
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-11-24
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
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