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    Clinical Trial Results:
    LONG-TERM 24-HOUR INTRAOCULAR PRESSURE CONTROL AND PROGRESSION RATE OBTAINED WITH THE ASSOCIATION OF COMBIGAN IN THE MORNING AND GANFORT IN THE EVENING COMPARED WITH LATANOPROST IN HIGH RISK OPEN-ANGLE GLAUCOMA.

    Summary
    EudraCT number
    		 2013-001634-17
    Trial protocol
    		 IT  
    Global end of trial date
    19 Dec 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Jul 2026
    First version publication date
    15 Jul 2026
    Other versions
    Summary report(s)
    		 Report MAF-ISS-OPH-GLA-035

    Trial information

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    Trial identification
    Sponsor protocol code
    MAF/ISS/OPH/GLA/035
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AZIENDA OSPEDALIERA SAN PAOLO
    Sponsor organisation address
    Via Antonio di rudinì 8, Milan, Italy, 20142
    Public contact
    Director of ophthalmology, AZIENDA OSPEDALIERA SAN PAOLO, 02 50323150, luca.rossetti@unimi.it
    Scientific contact
    Director of ophthalmology, AZIENDA OSPEDALIERA SAN PAOLO, 02 50323150, luca.rossetti@unimi.it
    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
    01 Feb 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Oct 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Dec 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare for the first time the quality of 24-hour IOP control obtained after 3 and 24 months of therapy with the combined administration of Combigan in the morning and Ganfort in the evening versus latanoprost administered once in the evening, in high risk newly diagnosed untreated patients with primary open-angle glaucoma (POAG), or exfoliative glaucoma (XFG) with IOP equal to or greater than 27 mm Hg and a visual field defect with an MD of at least -5 dB.
    Protection of trial subjects
    Not applicable
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Apr 2013
    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
    Italy: 30
    Country: Number of subjects enrolled
    Greece: 30
    Worldwide total number of subjects
    60
    EEA total number of subjects
    60
    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)
    30
    From 65 to 84 years
    30
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 patient screened with the medical chart and recruited during visits in clinic

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm A
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Latanaprost
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    One drop in the evening

    Arm title
    		 Arm b
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ganfort and combigan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    one drops of combigan in the morning and one drop of ganfort in the evening

    Number of subjects in period 1
    		Arm A Arm b
    Started
    30
    30
    Completed
    28
    27
    Not completed
    2
    3
         Physician decision
    2
    3

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 -

    Reporting group title
    Arm b
    Reporting group description
    		 -

    Primary: 24 hour iop control difference between group

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    End point title
    		 24 hour iop control difference between group
    End point description
    End point type
    Primary
    End point timeframe
    24 hour iop measure at 3, 8, 12,18 and 24 months from starting therapy
    End point values
    		 Arm A Arm b
    Number of subjects analysed
    28
    27
    Units: mmhg
        arithmetic mean (standard deviation)
    19.2 ( 2.2 )
    17.2 ( 2.2 )
    Statistical analysis title
    		 multivariate linear mixed model
    Comparison groups
    Arm A v Arm b
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 ≤ 0.05
    Method
    		 Mixed models analysis
    Confidence interval
    Notes
    [1] - multivariate linear mixed model that had the Arm, the Visit and the Time of day as predictors and the IOP as the response variable

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    30-apr-2013 to 19-Dec-2016
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16
    Reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 -

    Reporting group title
    Arm b
    Reporting group description
    		 -

    Serious adverse events
    		 Arm A Arm b
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Arm A Arm b
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 30 (6.67%)
    3 / 30 (10.00%)
    Eye disorders
    hyperemia
         subjects affected / exposed
    2 / 30 (6.67%)
    3 / 30 (10.00%)
         occurrences all number
    1
    1
    uncontrolled iop
         subjects affected / exposed
    2 / 30 (6.67%)
    3 / 30 (10.00%)
         occurrences all number
    1
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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
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    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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