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    Summary
    EudraCT Number:2016-003361-25
    Sponsor's Protocol Code Number:SHP640-303
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-02-28
    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 ConcernedUK - MHRA
    A.2EudraCT number2016-003361-25
    A.3Full title of the trial
    A Phase 3, Multi-center, Randomized, Double-Masked Study to Evaluate the Clinical Efficacy and Safety of SHP640 (PVP-Iodine 0.6% and Dexamethasone 0.1%) Ophthalmic Suspension Compared to Placebo in the Treatment of Bacterial Conjunctivitis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    SHP640 in the Treatment of Bacterial Conjunctivitis
    A.4.1Sponsor's protocol code numberSHP640-303
    A.5.4Other Identifiers
    Name:IND numberNumber:75,723
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/313/2016
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorShire Human Genetic Therapies, Inc.
    B.1.3.4CountryUnited States
    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 supportShire Human Genetic Therapies, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationShire Human Genetic Therapies, Inc.
    B.5.2Functional name of contact pointStudy Manager
    B.5.3 Address:
    B.5.3.1Street Address300 Shire Way
    B.5.3.2Town/ cityLexington
    B.5.3.3Post codeMA 02421
    B.5.3.4CountryUnited States
    B.5.6E-mailsgust-c@shire.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 nameSHP640
    D.3.2Product code SHP640
    D.3.4Pharmaceutical form Eye drops
    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 INNDexamethasone
    D.3.9.1CAS number 50 - 02 - 2
    D.3.9.2Current sponsor codeSRD006094
    D.3.9.3Other descriptive nameDEXAMETHASONE, MICRONIZED, USP
    D.3.9.4EV Substance CodeSUB171170
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.1
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPovidone Iodine
    D.3.9.1CAS number 25655-41-8
    D.3.9.2Current sponsor codeSRD006095, PVP-I
    D.3.9.3Other descriptive namePOVIDONE, IODINATED
    D.3.9.4EV Substance CodeSUB14999MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.6
    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 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 namePVP-I
    D.3.2Product code PVP-I
    D.3.4Pharmaceutical form Eye drops
    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 INNPovidone Iodine
    D.3.9.1CAS number 25655-41-8
    D.3.9.2Current sponsor codeSRD006095, PVP-I
    D.3.9.3Other descriptive namePOVIDONE, IODINATED
    D.3.9.4EV Substance CodeSUB14999MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.6
    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
    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
    Bacterial Conjunctivitis
    E.1.1.1Medical condition in easily understood language
    pink eye
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10061784
    E.1.2Term Conjunctivitis bacterial
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to evaluate the efficacy of SHP640 based on clinical resolution (defined as absence of bulbar conjunctival injection and ocular conjunctival discharge) compared with placebo in the treatment of subjects with bacterial conjunctivitis in the study eye at Visit 3 (Day 5).
    E.2.2Secondary objectives of the trial
    The key secondary objective of this study is to evaluate the efficacy of SHP640 based on bacterial eradication (defined as absence of all bacterial species present at or above pathological threshold at baseline) compared with placebo in the treatment of subjects with bacterial conjunctivitis in the study eye at Visit 3 (Day 5).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Main Inclusion Criteria:
    3. Subjects of any age at Visit 1 (Note: subjects <3 months of age at Visit 1 must have been full-term, ie ≥37 weeks gestational age at birth).
    4. Have a negative AdenoPlus® test in both eyes within 24 hours of Visit 1 or at Visit 1.
    5. Have a clinical diagnosis of suspected bacterial conjunctivitis in at least 1 eye confirmed by the presence of the following minimal clinical signs and symptoms in that same eye:
    5.1. Report presence of signs and/or symptoms of bacterial conjunctivitis for ≤3 days prior to Visit 1
    5.2. Bulbar conjunctival injection: a grade of ≥1 on 0-4 scale of Bulbar Conjunctival Injection Scale
    5.3. Ocular conjunctival discharge: a grade of ≥1 (mild) on a 0-3 scale of Ocular Conjunctival Discharge Scale
    6. Be willing to discontinue contact lens wear for the duration of the study.

    Full list of Inclusion criteria can be found in the protocol.
    E.4Principal exclusion criteria
    Main Exclusion Criteria:
    1. Current or recurrent disease that could affect the action, absorption, or disposition of the investigational product, or clinical or laboratory assessments, per investigator’s discretion.
    2. Current or relevant history of physical or psychiatric illness, any medical disorder that may make the subject unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or procedures.
    3. Have known or suspected intolerance or hypersensitivity to the investigational product, closely related compounds, or any of the stated ingredients.
    6. Have a history of ocular surgical intervention within ≤6 months prior to Visit 1 or planned for the period of the study.
    7. Have a preplanned overnight hospitalization during the period of the study.
    8. Have presence of any intraocular, corneal, or conjunctival ocular inflammation (eg, uveitis, iritis, ulcerative keratitis, chronic blepharoconjunctivitis), other than bacterial conjunctivitis.
    9. Have active or a history of ocular herpes.
    10. Have at enrollment or within ≤30 days of Visit 1, a clinical presentation more consistent with the diagnosis of ocular allergy, toxic conjunctivitis, or non-bacterial ocular infection (eg, viral, fungal, acanthamoebal, other parasitic).
    11. Neonates or infants (ie. subjects less than 12 months of age) who have suspected or confirmed (based on the result of any test conducted prior to screening) conjunctivitis of gonococcal, chlamydial, herpetic or chemical origin.
    12. Neonates or infants (ie. subjects less than 12 months of age) whose birth mothers had any sexually transmitted disease within 1 month of delivery or any history of genital herpes.
    13. Presence of nasolacrimal duct obstruction at Visit 1 (Day 1).
    14. Presence of any significant ophthalmic condition (eg, Retinopathy of Prematurity, congenital cataract, congenital glaucoma) or other congenital disorder with ophthalmic involvement that could affect study variables.
    15. Be a known intraocular pressure (IOP) steroid responder, have a known history of glaucoma, be a glaucoma suspect, or have a known history of an elevated IOP >21 mmHg
    16. Have any known clinically significant optic nerve defects.
    17. Have a history of recurrent corneal erosion syndrome, either idiopathic or secondary to previous corneal trauma or dry eye syndrome; presence of corneal epithelial defect or any significant corneal opacity at Visit 1.
    18. Presence of significant, active condition in the posterior segment that requires invasive treatment (eg, intravitreal treatment with vascular endothelial growth factor inhibitors or corticosteroids) and may progress during the study participation period.

    Full list of Exclusion criteria can be found in the protocol.
    E.5 End points
    E.5.1Primary end point(s)
    Clinical resolution status (defined as absence of bulbar conjunctival injection and ocular conjunctival discharge) in the study eye at Visit 3 (Day 5) between SHP640 and placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visit 3 (Day 5)
    E.5.2Secondary end point(s)
    Key Secondary Efficacy Endpoints:
    1.Bacterial eradication status (defined as absence of all bacterial species present at or above pathological threshold at baseline) in the study eye at Visit 3 (Day 5) between SHP640 and placebo.
    Secondary Efficacy Endpoints:
    2. Clinical resolution status of bacterial conjunctivitis at Visits 2 (Day 3), 4 (Day 8), and 5 (Day 12) in the study eye
    3. Bacterial eradication status (defined as absence of all bacterial species present at or above pathological threshold at baseline) as assessed by bacterial culture at Visits 2 (Day 3), 4 (Day 8), and 5 (Day 12) in the study eye
    4. Absolute and change from baseline of the individual clinical signs (bulbar conjunctival injection and ocular conjunctival discharge) at Visits 2 (Day 3), 3 (Day 5), 4 (Day 8), and 5 (Day 12) in the study eye
    5.The global clinical score (defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge) and change from baseline in the global clinical score at Visits 2 (Day 3), 3 (Day 5), 4 (Day 8), and 5 (Day 12) in the study eye
    6. Modified clinical resolution status, defined as a global clinical score of 0 or 1, at Visits 2 (Day 3), 3 (Day 5), 4 (Day 8), and 5 (Day 12) in the study eye
    7. Expanded clinical resolution status, defined as a global clinical score of 0, 1, or 2 with neither injection nor discharge having a score of 2, at Visits 2 (Day 3), 3 (Day 5), 4 (Day 8), and 5 (Day 12) in the study eye
    8. Time to clinical resolution based upon assessments at Visits 2 (Day 3), 3 (Day 5), 4 (Day 8), and 5 (Day 12) in the study eye
    9. Use of rescue medication
    Safety Endpoints:
    - BCVA
    - Slit lamp biomicroscopy
    - Non-dilated/dilated fundus examination
    - Urine pregnancy testing
    - Adverse events
    E.5.2.1Timepoint(s) of evaluation of this end point
    1.Visit 3 (Day 5)
    2. Visits 2 (Day 3), 4 (Day 8), and 5 (Day 12)
    3. Visits 2 (Day 3), 4 (Day 8), and 5 (Day 12)
    4. Visits 2 (Day 3), 3 (Day 5), 4 (Day 8), and 5 (Day 12)
    5. Visits 2 (Day 3), 3 (Day 5), 4 (Day 8), and 5 (Day 12)
    6. Visits 2 (Day 3), 3 (Day 5), 4 (Day 8), and 5 (Day 12)
    7. Visits 2 (Day 3), 3 (Day 5), 4 (Day 8), and 5 (Day 12)
    8. Visits 2 (Day 3), 3 (Day 5), 4 (Day 8), and 5 (Day 12)
    9. throughout the study duration
    Safety Endpoints: throughout the study duration
    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 Yes
    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 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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    PVP-I
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA32
    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
    Australia
    Austria
    Canada
    Colombia
    Estonia
    France
    Germany
    Hungary
    India
    Israel
    Italy
    Peru
    Philippines
    Poland
    South Africa
    Spain
    United Kingdom
    United States
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months20
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months9
    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: 135
    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) Yes
    F.1.1.3.1Number of subjects for this age range: 8
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 25
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 69
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 33
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 634
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 85
    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
    newborns and infants
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 118
    F.4.2.2In the whole clinical trial 854
    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)
    None
    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 Decision2017-08-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-10-01
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