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    Clinical Trial Results:
    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 PVP-Iodine and Placebo in the Treatment of Adenoviral Conjunctivitis

    Summary
    EudraCT number
    		 2016-002439-14
    Trial protocol
    		 DE   EE   HU   GB   ES   PL   AT   FR   IT  
    Global end of trial date
    13 May 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Nov 2019
    First version publication date
    27 Nov 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SHP640-301
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02998541
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Shire
    Sponsor organisation address
    300 Shire Way, Lexington, United States, MA 02421
    Public contact
    Study Director, Shire, 1 8668425335, ClinicalTransparency@shire.com
    Scientific contact
    Study Director, Shire, 1 8668425335, ClinicalTransparency@shire.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001936-PIP01-16
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    13 May 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    13 May 2019
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to evaluate the efficacy of SHP640 based on clinical resolution (defined as absence of bulbar conjunctival injection and watery conjunctival discharge) compared with placebo in the treatment of subjects with adenoviral conjunctivitis in the study eye at Visit 3 (Day 6).
    Protection of trial subjects
    The study sponsor and any third party to whom aspects of the study management or monitoring have been delegated undertake their assigned roles for this study in compliance with all applicable industry regulations, ICH GCP Guideline E6 (R2) (2016), EU Directive 2001/20/EC and its updates, as well as all applicable national and local laws and regulations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Mar 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 144
    Country: Number of subjects enrolled
    United Kingdom: 2
    Country: Number of subjects enrolled
    Australia: 2
    Country: Number of subjects enrolled
    Austria: 3
    Country: Number of subjects enrolled
    Canada: 3
    Country: Number of subjects enrolled
    Estonia: 16
    Country: Number of subjects enrolled
    France: 1
    Country: Number of subjects enrolled
    Germany: 2
    Country: Number of subjects enrolled
    India: 21
    Country: Number of subjects enrolled
    Israel: 7
    Country: Number of subjects enrolled
    South Africa: 4
    Country: Number of subjects enrolled
    Spain: 14
    Worldwide total number of subjects
    219
    EEA total number of subjects
    38
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    10
    Adolescents (12-17 years)
    13
    Adults (18-64 years)
    196
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted at 97 sites in 15 countries between 27 March 2017 to 13 May 2019.

    Pre-assignment
    Screening details
    		 A total of 219 subjects were randomized and 196 completed the study. Among which 219 were included in intent-to-treat (ITT) population, 217 in safety population, 83 in modified intent-to-treat (mITT) population. Two subjects were included in ITT population but not in safety population.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 SHP640
    Arm description
    		 Subjects administered one drop of SHP640 (0.1 percent [%] dexamethasone and 0.6% PVP-I) ophthalmic suspension in each eye 4 times daily (QID) for 7 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    SHP640
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops
    Routes of administration
    Ocular use
    Dosage and administration details
    Subjects administered one drop of SHP640 (0.1 % dexamethasone and 0.6% PVP-I) ophthalmic suspension in each eye 4 times daily for 7 days.

    Arm title
    		 PVP-I 0.6%
    Arm description
    		 Subjects administered one drop of 0.6% PVP-I ophthalmic solution in each eye QID for 7 days.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Povidone Iodine (PVP-I)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops
    Routes of administration
    Ocular use
    Dosage and administration details
    Subjects administered one drop of 0.6% PVP-I ophthalmic solution in each eye QID for 7 days.

    Arm title
    		 Placebo
    Arm description
    		 Subjects administered one drop of placebo ophthalmic solution in each eye QID for 7 days.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops
    Routes of administration
    Ocular use
    Dosage and administration details
    Subjects administered one drop of placebo ophthalmic solution in each eye QID for 7 days.

    Number of subjects in period 1
    		SHP640 PVP-I 0.6% Placebo
    Started
    86
    90
    43
    Completed
    78
    81
    37
    Not completed
    8
    9
    6
         Consent withdrawn by subject
    3
    1
    -
         Physician decision
    -
    -
    3
         Adverse event, non-fatal
    4
    5
    1
         Withdrawal by Parent/Guardian
    -
    -
    1
         Lost to follow-up
    -
    3
    1
         Protocol deviation
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    SHP640
    Reporting group description
    		 Subjects administered one drop of SHP640 (0.1 percent [%] dexamethasone and 0.6% PVP-I) ophthalmic suspension in each eye 4 times daily (QID) for 7 days.

    Reporting group title
    PVP-I 0.6%
    Reporting group description
    		 Subjects administered one drop of 0.6% PVP-I ophthalmic solution in each eye QID for 7 days.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects administered one drop of placebo ophthalmic solution in each eye QID for 7 days.

    Reporting group values
    		 SHP640 PVP-I 0.6% Placebo Total
    Number of subjects
    		 86 90 43
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 41.3 ( 19.56 ) 42.7 ( 21.43 ) 43.4 ( 23.67 ) -
    Gender categorical
    Units: Subjects
        Female
    		 46 47 24 117
        Male
    		 40 43 19 102
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 2 0 2
        Asian
    		 14 11 5 30
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0
        Black or African American
    		 9 11 5 25
        White
    		 62 64 30 156
        More than one race
    		 0 0 3 3
        Unknown or Not Reported
    		 1 2 0 3
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 23 16 10 49
        Not Hispanic or Latino
    		 63 73 31 167
        Unknown or Not Reported
    		 0 1 2 3

    End points

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    End points reporting groups
    Reporting group title
    SHP640
    Reporting group description
    		 Subjects administered one drop of SHP640 (0.1 percent [%] dexamethasone and 0.6% PVP-I) ophthalmic suspension in each eye 4 times daily (QID) for 7 days.

    Reporting group title
    PVP-I 0.6%
    Reporting group description
    		 Subjects administered one drop of 0.6% PVP-I ophthalmic solution in each eye QID for 7 days.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects administered one drop of placebo ophthalmic solution in each eye QID for 7 days.

    Primary: Number of Subjects With Clinical Resolution Among Who Received SHP640 or Placebo on Day 6

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    End point title
    		 Number of Subjects With Clinical Resolution Among Who Received SHP640 or Placebo on Day 6 [1]
    End point description
    Clinical resolution of adenoviral conjunctivitis was defined as the absence (score=0) of bulbar conjunctival injection and watery conjunctival discharge in the study eye. The study eye was defined based on subjects bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline. Bulbar conjunctival injection was assessed based on a 0 (Normal conjunctival vascular pattern)-4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from the validated bulbar redness (VBR) scale. Watery conjunctival discharge was assessed based on a 0-3 scale (0 – None and 3 - Severe: Abundant quantity of watery discharge observed in the lower conjunctival fornix and in the lower lid margin). Higher score represent worse symptoms for both scores. mITT population was analyzed. Here,the number of subjects analyzed refer to subjects evaluable for this endpoint at specific arm group.
    End point type
    Primary
    End point timeframe
    Day 6
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The statistical analysis was not planned and not calculated.
    End point values
    		 SHP640 PVP-I 0.6% Placebo
    Number of subjects analysed
    32
    0 [2]
    14
    Units: Subjects
        Subjects
    3
    1
    Notes
    [2] - No subject was analyzed for this reporting group in the endpoint.
    No statistical analyses for this end point

    Secondary: Number of Subjects With Clinical Resolution Among Who Received SHP640 or Povidone-Iodine (PVP-I) on Day 6

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    End point title
    		 Number of Subjects With Clinical Resolution Among Who Received SHP640 or Povidone-Iodine (PVP-I) on Day 6
    End point description
    Clinical resolution of adenoviral conjunctivitis was defined as the absence (score=0) of bulbar conjunctival injection and watery conjunctival discharge in the study eye. The study eye was defined based on subjects bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline. Bulbar conjunctival injection was assessed based on a 0 (Normal conjunctival vascular pattern)-4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from the validated bulbar redness (VBR) scale. Watery conjunctival discharge was assessed based on a 0-3 scale (0 – None and 3 - Severe: Abundant quantity of watery discharge observed in the lower conjunctival fornix and in the lower lid margin). Higher score represent worse symptoms for both scores. mITT population was analyzed. Here,the number of subjects analyzed refer to subjects evaluable for this endpoint at specific arm group.
    End point type
    Secondary
    End point timeframe
    Day 6
    End point values
    		 SHP640 PVP-I 0.6% Placebo
    Number of subjects analysed
    32
    28
    0 [3]
    Units: Subjects
        Subjects
    3
    1
    Notes
    [3] - No subject was analyzed for this reporting group in the endpoint.
    No statistical analyses for this end point

    Secondary: Number of Subjects With Clinical Resolution Among Who Received Povidone-Iodine (PVP-I) or Placebo on Day 6

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    End point title
    		 Number of Subjects With Clinical Resolution Among Who Received Povidone-Iodine (PVP-I) or Placebo on Day 6
    End point description
    Clinical resolution of adenoviral conjunctivitis was defined as the absence (score=0) of bulbar conjunctival injection and watery conjunctival discharge in the study eye. The study eye was defined based on subjects bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline. Bulbar conjunctival injection was assessed based on a 0 (Normal conjunctival vascular pattern)-4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from the validated bulbar redness (VBR) scale. Watery conjunctival discharge was assessed based on a 0-3 scale (0 – None and 3 - Severe: Abundant quantity of watery discharge observed in the lower conjunctival fornix and in the lower lid margin). Higher score represent worse symptoms for both scores. mITT population was analyzed. Here,the number of subjects analyzed refer to subjects evaluable for this endpoint at specific arm group.
    End point type
    Secondary
    End point timeframe
    Day 6
    End point values
    		 SHP640 PVP-I 0.6% Placebo
    Number of subjects analysed
    0 [4]
    28
    14
    Units: Subjects
        Subjects
    1
    1
    Notes
    [4] - No subject was analyzed for this reporting group in the endpoint.
    No statistical analyses for this end point

    Secondary: Number of Subjects With Adenoviral Eradication Among Who Received Povidone-Iodine (PVP-I) or Placebo on Day 3

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    End point title
    		 Number of Subjects With Adenoviral Eradication Among Who Received Povidone-Iodine (PVP-I) or Placebo on Day 3
    End point description
    Adenoviral eradication for the study eye was defined as negative Cell Culture- Immunofluorescence Assay (CC-IFA) in that eye. Positive CC-IFA is considered not reaching adenoviral eradication. CC-IFA for each eye was conducted using conjunctival swab samples collected at each visit to determine the presence of adenovirus. The study eye was defined based on subjects bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline. mITT population consisted of of a subset of the ITT population (ITT population consisted of all screened subjects who were randomized) who received at least one dose of investigational product (IP) and had a positive CC-IFA adenovirus test at baseline in the study eye. Here, the number of subjects analyzed refer to the subjects evaluable for this endpoint at specific reporting arm.
    End point type
    Secondary
    End point timeframe
    Day 3
    End point values
    		 SHP640 PVP-I 0.6% Placebo
    Number of subjects analysed
    0 [5]
    27
    15
    Units: Subjects
        Subjects
    8
    2
    Notes
    [5] - No subject was analyzed for this reporting group in the endpoint.
    No statistical analyses for this end point

    Secondary: Number of Subjects With Adenoviral Eradication Among Who Received SHP640 or Placebo on Day 6

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    End point title
    		 Number of Subjects With Adenoviral Eradication Among Who Received SHP640 or Placebo on Day 6
    End point description
    Adenoviral eradication for the study eye was defined as negative CC-IFA in that eye. CC-IFA for each eye was conducted using conjunctival swab samples collected at each visit to determine the presence of adenovirus. The study eye was defined based on subjects bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline. mITT population consisted of of a subset of the ITT population who received at least one dose of investigational product (IP) and had a positive CC-IFA adenovirus test at baseline in the study eye. Here, the number of subjects analyzed refer to the subjects evaluable for this endpoint at specific reporting arm.
    End point type
    Secondary
    End point timeframe
    Day 6
    End point values
    		 SHP640 PVP-I 0.6% Placebo
    Number of subjects analysed
    30
    0 [6]
    14
    Units: Subjects
        Subjects
    14
    7
    Notes
    [6] - No subject was analyzed for this reporting group in the endpoint.
    No statistical analyses for this end point

    Secondary: Number of Subjects With Adenoviral Eradication Among Who Received SHP640 or Povidone-Iodine (PVP-I) on Day 6

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    End point title
    		 Number of Subjects With Adenoviral Eradication Among Who Received SHP640 or Povidone-Iodine (PVP-I) on Day 6
    End point description
    Adenoviral eradication for the study eye was defined as negative CC-IFA in that eye. CC-IFA for each eye was conducted using conjunctival swab samples collected at each visit to determine the presence of adenovirus. The study eye was defined based on subjects bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline. mITT population consisted of of a subset of the ITT population who received at least one dose of investigational product (IP) and had a positive CC-IFA adenovirus test at baseline in the study eye. Here, the number of subjects analyzed refer to the subjects evaluable for this endpoint at specific reporting arm.
    End point type
    Secondary
    End point timeframe
    Day 6
    End point values
    		 SHP640 PVP-I 0.6% Placebo
    Number of subjects analysed
    30
    28
    0 [7]
    Units: Subjects
        Subjects
    14
    20
    Notes
    [7] - No subject was analyzed for this reporting group in the endpoint.
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in Adenovirus Viral Titer as Assessed by Quantitative Polymerase Chain Reaction (qPCR) at Day 6 and 8

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    End point title
    		 Percent Change From Baseline in Adenovirus Viral Titer as Assessed by Quantitative Polymerase Chain Reaction (qPCR) at Day 6 and 8
    End point description
    Percent change from baseline in adenovirus viral titer as assessed by qPCR was reported. The sponsor discontinued the SHP640 clinical development program and, thus, terminated this study. Hence, for this endpoint, the planned data collection and analysis was not performed.
    End point type
    Secondary
    End point timeframe
    Day 6, 8
    End point values
    		 SHP640 PVP-I 0.6% Placebo
    Number of subjects analysed
    0 [8]
    0 [9]
    0 [10]
    Units: Subjects
    Notes
    [8] - The analysis was not performed due to study termination.
    [9] - The analysis was not performed due to study termination.
    [10] - The analysis was not performed due to study termination.
    No statistical analyses for this end point

    Secondary: Number of Subjects with Adenoviral Eradication on Day 8 and 12

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    End point title
    		 Number of Subjects with Adenoviral Eradication on Day 8 and 12
    End point description
    Adenoviral eradication for the study eye was defined as negative CC-IFA in that eye. CC-IFA for each eye was conducted using conjunctival swab samples collected at each visit to determine the presence of adenovirus. The study eye was defined based on subjects bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline. mITT population consisted of of a subset of the ITT population who received at least one dose of investigational product (IP) and had a positive CC-IFA adenovirus test at baseline in the study eye. Here, n = subjects evaluable for specified category for each arm, respectively. ET=Early Termination
    End point type
    Secondary
    End point timeframe
    Day 8 and 12/ET
    End point values
    		 SHP640 PVP-I 0.6% Placebo
    Number of subjects analysed
    36
    32
    15
    Units: Subjects
        Day 8 (n=28, 28, 15)
    20
    22
    13
        Day 12/ET (n= 31, 31, 14)
    28
    28
    13
    No statistical analyses for this end point

    Secondary: Number of Subjects With Clinical Resolution on Day 3, 8, 12

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    End point title
    		 Number of Subjects With Clinical Resolution on Day 3, 8, 12
    End point description
    Clinical resolution of adenoviral conjunctivitis was defined as the absence (score=0) of bulbar conjunctival injection and watery conjunctival discharge in the study eye. The study eye was defined based on subjects bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline. Bulbar conjunctival injection was assessed based on a 0 (Normal conjunctival vascular pattern)-4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from the validated bulbar redness (VBR) scale. Watery conjunctival discharge was assessed based on a 0-3 scale (0 – None and 3 - Severe: Abundant quantity of watery discharge observed in the lower conjunctival fornix and in the lower lid margin). Higher score represent worse symptoms for both scores. mITT population was analyzed. Here, n = subjects evaluable for specified category for each arm, respectively. ET=Early Termination
    End point type
    Secondary
    End point timeframe
    Day 3, 8, 12/ET
    End point values
    		 SHP640 PVP-I 0.6% Placebo
    Number of subjects analysed
    36
    32
    15
    Units: Subjects
        Day 3 (n=34, 30, 15)
    0
    0
    0
        Day 8 (n=29, 28, 15)
    6
    5
    3
        Day 12/ET (n=32, 31, 14)
    20
    13
    8
    No statistical analyses for this end point

    Secondary: Change from Baseline in Individual Clinical Signs Score at Day 3, 6, 8, 12

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    End point title
    		 Change from Baseline in Individual Clinical Signs Score at Day 3, 6, 8, 12
    End point description
    The Individual clinical signs score (bulbar conjunctival injection and watery conjunctival discharge) in the study were reported. The study eye was defined based on subjects bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline. The sponsor discontinued the SHP640 clinical development program and, thus, terminated this study. Hence, for this endpoint, the planned data collection and analysis was not performed.
    End point type
    Secondary
    End point timeframe
    Day 3, 6, 8, 12
    End point values
    		 SHP640 PVP-I 0.6% Placebo
    Number of subjects analysed
    0 [11]
    0 [12]
    0 [13]
    Units: Subjects
    Notes
    [11] - The analysis was not performed due to study termination.
    [12] - The analysis was not performed due to study termination.
    [13] - The analysis was not performed due to study termination.
    No statistical analyses for this end point

    Secondary: Number of Subjects with at Least 2 Point Reduction From Baseline in the Global Clinical Score at Day 3, 6, 8 and 12

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    End point title
    		 Number of Subjects with at Least 2 Point Reduction From Baseline in the Global Clinical Score at Day 3, 6, 8 and 12
    End point description
    Global clinical score was the sum of bulbar conjunctival injection and watery conjunctival discharge. The study eye was defined based on subjects bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline. mITT population consisted of of a subset of the ITT population who received at least one dose of investigational product (IP) and had a positive CC-IFA adenovirus test at baseline in the study eye. Here, n = subjects evaluable for specified category for each arm, respectively. ET=Early Termination
    End point type
    Secondary
    End point timeframe
    Day 3, 6, 8 and 12/ET
    End point values
    		 SHP640 PVP-I 0.6% Placebo
    Number of subjects analysed
    36
    32
    15
    Units: Subjects
        Day 3 (n=34, 30, 15)
    15
    5
    7
        Day 6 (n=32,28,14)
    22
    20
    11
        Day 8 (n=29, 28, 15)
    24
    23
    13
        Day 12/ET (n=32, 31,14)
    30
    27
    12
    No statistical analyses for this end point

    Secondary: Number of Subjects with Modified Clinical Resolution on Day 3, 6, 8, 12

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    End point title
    		 Number of Subjects with Modified Clinical Resolution on Day 3, 6, 8, 12
    End point description
    Modified clinical resolution was defined as a global clinical score of 0 or 1. Global clinical score was the sum of bulbar conjunctival injection and watery conjunctival discharge. The study eye was defined based on subjects bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline. The sponsor discontinued the SHP640 clinical development program and, thus, terminated this study. Hence, for this endpoint, the planned data collection and analysis was not performed.
    End point type
    Secondary
    End point timeframe
    Day 3, 6, 8, 12
    End point values
    		 SHP640 PVP-I 0.6% Placebo
    Number of subjects analysed
    0 [14]
    0 [15]
    0 [16]
    Units: Subjects
    Notes
    [14] - The analysis was not performed due to study termination.
    [15] - The analysis was not performed due to study termination.
    [16] - The analysis was not performed due to study termination.
    No statistical analyses for this end point

    Secondary: Number of Subjects with Expanded Clinical Resolution on Day 3, 6, 8, 12

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    End point title
    		 Number of Subjects with Expanded Clinical Resolution on Day 3, 6, 8, 12
    End point description
    Expanded clinical resolution was defined as a global clinical score of 0, 1, or 2 with neither injection nor discharge having a score of 2. Global clinical score was the sum of bulbar conjunctival injection and watery conjunctival discharge. The study eye was defined based on subjects bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline. The sponsor discontinued the SHP640 clinical development program and, thus, terminated this study. Hence, for this endpoint, the planned data collection and analysis was not performed.
    End point type
    Secondary
    End point timeframe
    Day 3, 6, 8, 12
    End point values
    		 SHP640 PVP-I 0.6% Placebo
    Number of subjects analysed
    0 [17]
    0 [18]
    0 [19]
    Units: Subjects
    Notes
    [17] - The analysis was not performed due to study termination.
    [18] - The analysis was not performed due to study termination.
    [19] - The analysis was not performed due to study termination.
    No statistical analyses for this end point

    Secondary: Number of Subjects with Status of Cross-over Infection on Day 3, 6, 8, 12

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    End point title
    		 Number of Subjects with Status of Cross-over Infection on Day 3, 6, 8, 12
    End point description
    Number of subjects with status of cross-over infection to a subject’s fellow eye. Subjects with only 1 infected eye at baseline were reported. The sponsor discontinued the SHP640 clinical development program and, thus, terminated this study. Hence, for this endpoint, the planned data collection and analysis was not performed.
    End point type
    Secondary
    End point timeframe
    Day 3, 6, 8, 12
    End point values
    		 SHP640 PVP-I 0.6% Placebo
    Number of subjects analysed
    0 [20]
    0 [21]
    0 [22]
    Units: Subjects
    Notes
    [20] - The analysis was not performed due to study termination.
    [21] - The analysis was not performed due to study termination.
    [22] - The analysis was not performed due to study termination.
    No statistical analyses for this end point

    Secondary: Time to Clinical Resolution on Day 3, 6, 8, 12

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    End point title
    		 Time to Clinical Resolution on Day 3, 6, 8, 12
    End point description
    Time to clinical resolution were reported based on the assessments in the study eye. The sponsor discontinued the SHP640 clinical development program and, thus, terminated this study. Hence, for this endpoint, the planned data collection and analysis was not performed.
    End point type
    Secondary
    End point timeframe
    Day 3, 6, 8, 12
    End point values
    		 SHP640 PVP-I 0.6% Placebo
    Number of subjects analysed
    0 [23]
    0 [24]
    0 [25]
    Units: Hours
        median (full range (min-max))
    ( to )
    ( to )
    ( to )
    Notes
    [23] - The analysis was not performed due to study termination.
    [24] - The analysis was not performed due to study termination.
    [25] - The analysis was not performed due to study termination.
    No statistical analyses for this end point

    Secondary: Number of Subjects with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Event (SAEs) of SHP640

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    End point title
    		 Number of Subjects with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Event (SAEs) of SHP640
    End point description
    An Adverse Event (AE) was any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. A SAE was any untoward medical occurrence (whether considered to be related to investigational product or not) that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect, is an important medical event. Any AE that occured after the first dose of IP instillation was considered a TEAE. Safety Population consisted of all subjects who received at least one dose of investigational product (IP).
    End point type
    Secondary
    End point timeframe
    From start of the study up to Day 14
    End point values
    		 SHP640 PVP-I 0.6% Placebo
    Number of subjects analysed
    86
    90
    41
    Units: Subjects
        Number of subjects with TEAEs
    23
    28
    10
        Number of subjects with SAEs
    0
    1
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From start of the study up to Day 14
    Adverse event reporting additional description
    219 subjects were included in ITT population but only 217 subjects were included in safety population.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    SHP640
    Reporting group description
    		 Subjects administered one drop of SHP640 (0.1 percent [%] dexamethasone and 0.6% PVP-I) ophthalmic suspension in each eye 4 times daily (QID) for 7 days.

    Reporting group title
    PVP-I 0.6%
    Reporting group description
    		 Subjects administered one drop of PVP-I ophthalmic solution in each eye QID (with a minimum of 2 hours between doses) for 7 days.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects administered one drop of placebo ophthalmic solution in each eye QID (with a minimum of 2 hours between doses) for 7 days.

    Serious adverse events
    		 SHP640 PVP-I 0.6% Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 90 (1.11%)
    0 / 41 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Infections and infestations
    Pneumonia bacterial
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 90 (1.11%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 SHP640 PVP-I 0.6% Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 86 (13.95%)
    8 / 90 (8.89%)
    1 / 41 (2.44%)
    General disorders and administration site conditions
    Instillation site pain
         subjects affected / exposed
    12 / 86 (13.95%)
    8 / 90 (8.89%)
    1 / 41 (2.44%)
         occurrences all number
    12
    8
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Jun 2016
    -No subjects were enrolled under the original protocol, and Amendment 1 was the initial effective protocol for this study.
    28 Nov 2016
    -Added the discontinuation of subjects less than 2 months old who tested positive for the presence of chlamydia or gonorrhea. - Added the discontinuation of subjects who tested positive for Herpes simplex virus (HSV) in either eye at baseline and added testing for HSV by qPCR in all subjects at baseline.
    13 Dec 2017
    -Inclusion criterion stated that subjects must have had a clinical diagnosis of suspected adenoviral conjunctivitis in at least 1 eye. This must have been confirmed by the presence of minimal clinical signs and symptoms in that same eye. The window for one of these (presence of adenoviral conjunctivitis) was increased from less than or equal to (< or =) 3 days prior to Visit 1 to < or = 4 days prior to Visit 1. -Clarified the exclusion criterion relating to a clinical presentation more consistent with the diagnosis of non-infectious conjunctivitis. -Removed the exclusion criterion relating to subjects with a known history of elevated intraocular pressure greater than (>) 21 millimeters of mercury (mmHg). -Added windows for Study Visit 2, 4, and 5, and changed the window for the inclusion criterion relating to adenoviral conjunctivitis. -Clarified the safety follow-up to be conducted for subjects who tested positive for HSV in either eye.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The study was terminated as the clinical development of SHP640 was discontinued.
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