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    Clinical Trial Results:
    Randomized parallel-group, multicentre study to evaluate the after-use sensation and safety of carteolol LA 2% versus timolol LA 0.5% in simple intra-ocular hypertension and glaucoma.

    Summary
    EudraCT number
    		 2007-001680-30
    Trial protocol
    		 FR   PT   BE   CZ  
    Global end of trial date
    05 May 2009

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Aug 2020
    First version publication date
    27 Aug 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    529
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bausch and Lomb
    Sponsor organisation address
    Brunsbütteler Damm 165-173, Berlin, Germany,
    Public contact
    Manager Clinical Science, Bausch&Lomb Dr Gerhard Mann chem.-Fabrik GmbH, natasa.orlic-pleyer@bausch.com
    Scientific contact
    Manager Clinical Science, Bausch&Lomb Dr Gerhard Mann chem.-Fabrik GmbH, Raphaele.SiouMermet@bausch.com
    Sponsor organisation name
    Bausch and Lomb
    Sponsor organisation address
    Brunsbütteler Damm 165-173, Berlin, Germany, 13581
    Public contact
    Manager Clinical Science, Bausch and Lomb, 331 60795083,
    Scientific contact
    Manager Clinical Science, Bausch and Lomb, 331 60795083,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    05 May 2009
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 May 2009
    Global end of trial reached?
    Yes
    Global end of trial date
    05 May 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary objective: To evaluate the subjective tolerance upon instillation (rate of patients experiencing symptoms of ocular discomfort ) of carteolol LA compared to timolol LA in patients with simple ocular hypertension or POAG (superiority design)
    Protection of trial subjects
    This study was conducted in compliance with the protocol and in accordance with Good Clinical Practices (GCPs), as described in the ICH Harmonized Tripartite Guidelines for Good Clinical Practice 1996, applicable local regulations, and the Declaration of Helsinki (2004).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 Feb 2008
    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
    Poland: 9
    Country: Number of subjects enrolled
    Portugal: 21
    Country: Number of subjects enrolled
    Belgium: 16
    Country: Number of subjects enrolled
    Czech Republic: 123
    Country: Number of subjects enrolled
    France: 30
    Worldwide total number of subjects
    199
    EEA total number of subjects
    199
    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)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    111
    From 65 to 84 years
    83
    85 years and over
    5

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 After providing informed consent, subjects were screened for inclusion. Subjects with unilateral or bilateral OHT or POAG and whose IOP was being controlled by beta-blocker monotherapy were enrolled in this study. If both eyes were diagnosed with OHT or POAG, both eyes were treated.

    Period 1
    Period 1 title
    Treatment (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
    		 Carteolol LA
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Carteolol LA
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops
    Routes of administration
    Ocular use
    Dosage and administration details
    Subjects were instructed to instill one drop daily into the conjunctival sac at 8:00 AM.

    Arm title
    		 Timolol LA
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Timolol LA
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops
    Routes of administration
    Ocular use
    Dosage and administration details
    Subjects were instructed to instill one drop daily into the conjunctival sac at 8:00 AM.

    Number of subjects in period 1
    		Carteolol LA Timolol LA
    Started
    101
    98
    Completed
    97
    90
    Not completed
    4
    8
         Consent withdrawn by subject
    -
    4
         Adverse event, non-fatal
    1
    3
         Other
    1
    1
         Lost to follow-up
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment
    Reporting group description
    		 -

    Reporting group values
    		 Treatment Total
    Number of subjects
    		 199 199
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 111 111
        From 65-84 years
    		 83 83
        85 years and over
    		 5 5
    Gender categorical
    Units: Subjects
        Female
    		 134 134
        Male
    		 65 65

    End points

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    End points reporting groups
    Reporting group title
    Carteolol LA
    Reporting group description
    		 -

    Reporting group title
    Timolol LA
    Reporting group description
    		 -

    Primary: Number of subjects who felt discomfort upon instillation at 90 days

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    End point title
    		 Number of subjects who felt discomfort upon instillation at 90 days
    End point description
    End point type
    Primary
    End point timeframe
    90 days
    End point values
    		 Carteolol LA Timolol LA
    Number of subjects analysed
    97
    90
    Units: Subjects
    18
    25
    Statistical analysis title
    		 Comparison of treatment arms
    Comparison groups
    Carteolol LA v Timolol LA
    Number of subjects included in analysis
    187
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1354
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Number of subjects who felt discomfort upon instillation at 30 days

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    End point title
    		 Number of subjects who felt discomfort upon instillation at 30 days
    End point description
    End point type
    Secondary
    End point timeframe
    30 days
    End point values
    		 Carteolol LA Timolol LA
    Number of subjects analysed
    98
    93
    Units: Subjects
    21
    37
    No statistical analyses for this end point

    Secondary: Global subjective tolerance upon instillation at 90 days

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    End point title
    		 Global subjective tolerance upon instillation at 90 days
    End point description
    End point type
    Secondary
    End point timeframe
    90 days
    End point values
    		 Carteolol LA Timolol LA
    Number of subjects analysed
    97
    90
    Units: Subjects
        Very Bad
    1
    2
        Bad
    2
    2
        Good
    27
    20
        Very Good
    67
    66
    No statistical analyses for this end point

    Secondary: Global subjective tolerance upon instillation at 30 days

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    End point title
    		 Global subjective tolerance upon instillation at 30 days
    End point description
    End point type
    Secondary
    End point timeframe
    30 days
    End point values
    		 Carteolol LA Timolol LA
    Number of subjects analysed
    98
    93
    Units: Subjects
        Very Bad
    2
    0
        Bad
    1
    4
        Good
    31
    28
        Very Good
    64
    61
    No statistical analyses for this end point

    Secondary: Blurry/Dim Vision According to the Glaucoma Symptom Scale at 90 days

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    End point title
    		 Blurry/Dim Vision According to the Glaucoma Symptom Scale at 90 days
    End point description
    End point type
    Secondary
    End point timeframe
    90 days
    End point values
    		 Carteolol LA Timolol LA
    Number of subjects analysed
    18
    25
    Units: Subjects
        Very Bothersome
    0
    3
        Somewhat Bothersome
    1
    1
        A Little Bothersome
    1
    9
        Not at All Bothersome
    16
    12
    No statistical analyses for this end point

    Secondary: Blurry/Dim Vision According to the Glaucoma Symptom Scale at 30 days

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    End point title
    		 Blurry/Dim Vision According to the Glaucoma Symptom Scale at 30 days
    End point description
    End point type
    Secondary
    End point timeframe
    30 days
    End point values
    		 Carteolol LA Timolol LA
    Number of subjects analysed
    21
    37
    Units: Subjects
        Very Bothersome
    0
    2
        Somewhat Bothersome
    0
    5
        A Little Bothersome
    5
    14
        Not at All Bothersome
    16
    16
    No statistical analyses for this end point

    Secondary: ''Inflammation of eyelids" at external eye examination at 90 days

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    End point title
    		 ''Inflammation of eyelids" at external eye examination at 90 days
    End point description
    End point type
    Secondary
    End point timeframe
    90 days
    End point values
    		 Carteolol LA Timolol LA
    Number of subjects analysed
    97
    90
    Units: Subjects
    3
    6
    No statistical analyses for this end point

    Secondary: "Bulbar motility" at external eye examination at 90 days

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    End point title
    		 "Bulbar motility" at external eye examination at 90 days
    End point description
    End point type
    Secondary
    End point timeframe
    90 days
    End point values
    		 Carteolol LA Timolol LA
    Number of subjects analysed
    97
    90
    Units: Subjects
    0
    1
    No statistical analyses for this end point

    Secondary: Severe 'Lens' abnormality by slit lamp examination by 90 days

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    End point title
    		 Severe 'Lens' abnormality by slit lamp examination by 90 days
    End point description
    End point type
    Secondary
    End point timeframe
    90 days
    End point values
    		 Carteolol LA Timolol LA
    Number of subjects analysed
    97
    90
    Units: Subjects
    3
    3
    No statistical analyses for this end point

    Secondary: Tear film break-up time at 90 days

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    End point title
    		 Tear film break-up time at 90 days
    End point description
    End point type
    Secondary
    End point timeframe
    90 days
    End point values
    		 Carteolol LA Timolol LA
    Number of subjects analysed
    97
    90
    Units: Seconds
        arithmetic mean (standard deviation)
    13.822 ± 5.048
    13.802 ± 5.558
    No statistical analyses for this end point

    Secondary: Tear film break-up time at 30 days

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    End point title
    		 Tear film break-up time at 30 days
    End point description
    End point type
    Secondary
    End point timeframe
    30 days
    End point values
    		 Carteolol LA Timolol LA
    Number of subjects analysed
    98
    93
    Units: Seconds
        arithmetic mean (standard error)
    13.541 ± 5.188
    13.608 ± 5.294
    No statistical analyses for this end point

    Secondary: Fluorescein staining at 90 days

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    End point title
    		 Fluorescein staining at 90 days
    End point description
    End point type
    Secondary
    End point timeframe
    90 days
    End point values
    		 Carteolol LA Timolol LA
    Number of subjects analysed
    97
    90
    Units: Grade
        arithmetic mean (standard error)
    0.2 ± 0.5
    0.3 ± 0.6
    No statistical analyses for this end point

    Secondary: Fluorescein staining at 30 days

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    End point title
    		 Fluorescein staining at 30 days
    End point description
    End point type
    Secondary
    End point timeframe
    30 days
    End point values
    		 Carteolol LA Timolol LA
    Number of subjects analysed
    98
    93
    Units: Grade
        arithmetic mean (standard deviation)
    0.3 ± 0.5
    0.3 ± 0.7
    No statistical analyses for this end point

    Secondary: Overall lissamine test result at 90 days

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    End point title
    		 Overall lissamine test result at 90 days
    End point description
    End point type
    Secondary
    End point timeframe
    90 days
    End point values
    		 Carteolol LA Timolol LA
    Number of subjects analysed
    97
    90
    Units: Grade
        arithmetic mean (standard deviation)
    0.6 ± 1.4
    0.5 ± 1.0
    No statistical analyses for this end point

    Secondary: Overall lissamine test result at 30 days

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    End point title
    		 Overall lissamine test result at 30 days
    End point description
    End point type
    Secondary
    End point timeframe
    30 days
    End point values
    		 Carteolol LA Timolol LA
    Number of subjects analysed
    98
    93
    Units: Grade
        arithmetic mean (standard deviation)
    0.7 ± 1.4
    0.5 ± 0.9
    No statistical analyses for this end point

    Secondary: Result of examination of the macula by fundoscopy at 90 days

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    End point title
    		 Result of examination of the macula by fundoscopy at 90 days
    End point description
    End point type
    Secondary
    End point timeframe
    90 days
    End point values
    		 Carteolol LA Timolol LA
    Number of subjects analysed
    97
    89
    Units: Subjects
        Normal
    94
    86
        Abnormal
    3
    3
    No statistical analyses for this end point

    Secondary: "Lid Closure" at external eye examination at 90 days

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    End point title
    		 "Lid Closure" at external eye examination at 90 days
    End point description
    End point type
    Secondary
    End point timeframe
    90 days
    End point values
    		 Carteolol LA Timolol LA
    Number of subjects analysed
    97
    90
    Units: Subjects
    1
    2
    No statistical analyses for this end point

    Secondary: "Lid motility" at external eye examination at 90 days

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    End point title
    		 "Lid motility" at external eye examination at 90 days
    End point description
    End point type
    Secondary
    End point timeframe
    90 days
    End point values
    		 Carteolol LA Timolol LA
    Number of subjects analysed
    97
    90
    Units: Subjects
    2
    3
    No statistical analyses for this end point

    Secondary: "Conjunctival injection" at external eye examination at 90 days

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    End point title
    		 "Conjunctival injection" at external eye examination at 90 days
    End point description
    End point type
    Secondary
    End point timeframe
    90 days
    End point values
    		 Carteolol LA Timolol LA
    Number of subjects analysed
    97
    90
    Units: Subjects
    6
    3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    90 days
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    NA
    Reporting groups
    Reporting group title
    Carteolol LA
    Reporting group description
    		 -

    Reporting group title
    Timolol LA
    Reporting group description
    		 -

    Serious adverse events
    		 Carteolol LA Timolol LA
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 99 (0.00%)
    0 / 95 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Carteolol LA Timolol LA
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 99 (1.01%)
    2 / 95 (2.11%)
    Eye disorders
    Cataract
         subjects affected / exposed
    1 / 99 (1.01%)
    2 / 95 (2.11%)
         occurrences all number
    1
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Nov 2007
    Czech Republic only: • the Exclusion Criterion for pregnant or lactating women was changed so that a urine pregnancy test was required for women of childbearing potential • in the Withdrawal of Subjects from Therapy or Assessment section (Section 6.3), a sentence was added stating that women that become pregnant during the study would be discontinued from treatment but would continue to be followed for safety evaluation per the protocol defined visits • in the Baseline Visit section, that a urine pregnancy test must be administered if applicable

    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.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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