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    Clinical Trial Results:
    An open, non-randomized study on the effect of preservative free tafluprost (Saflutan® Augentropfen) in patients with ocular hypertension or with primary open angle glaucoma with an uncontrolled intraocular pressure of 30 mmHg and more

    Summary
    EudraCT number
    		 2013-003157-16
    Trial protocol
    		 AT  
    Global end of trial date
    01 Apr 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Mar 2016
    First version publication date
    19 Mar 2016
    Other versions
    Summary report(s)
    		 Publication

    Trial information

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    Trial identification
    Sponsor protocol code
    OPHT-260213
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01979913
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Ordination Dr. Hommer
    Sponsor organisation address
    Albertgasse 39, Vienna, Austria, 1080
    Public contact
    Dr. Anton Hommer, Ordination Dr. Hommer, +43 1408347715,
    Scientific contact
    Dr. Anton Hommer, Ordination Dr. Hommer, +43 1408347715,
    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
    22 Sep 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Apr 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Apr 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the effect of saflutan eye drops on intraocular pressure
    Protection of trial subjects
    Measurement of intraocular pressure
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Oct 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
    Austria: 16
    Worldwide total number of subjects
    16
    EEA total number of subjects
    16
    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)
    7
    From 65 to 84 years
    9
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 17 patients was recruited and screened. 16 of them were included in the study, since 1 patient did not fulfill all inclusion criteria.

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 16
    Number of subjects completed
    		 16

    Period 1
    Period 1 title
    Treatment period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Patients with glaucoma or ocular hypertension
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Saflutan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops
    Routes of administration
    Ocular use
    Dosage and administration details
    1 drop (0.3ml)/day

    Number of subjects in period 1
    		Patients with glaucoma or ocular hypertension
    Started
    16
    Completed
    16

    Baseline characteristics

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

    Reporting group values
    		 Treatment period Total
    Number of subjects
    		 16 16
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 62.3 ( 11.8 ) -
    Gender categorical
    Units: Subjects
        Female
    		 8 8
        Male
    		 8 8
    Intraocular pressure after the washout period in the morning
    Baseline value for IOP in the morning
    Units: mmHg
        arithmetic mean (standard deviation)
    		 35.6 ( 4.5 ) -
    Intraocular pressure after the washout period in the evening
    Baseline value for IOP in the evening
    Units: mmHg
        arithmetic mean (standard deviation)
    		 32.9 ( 5.4 ) -

    End points

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    End points reporting groups
    Reporting group title
    Patients with glaucoma or ocular hypertension
    Reporting group description
    		 -

    Primary: Intraocular pressure after 8 weeks treatment in the morning

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    End point title
    		 Intraocular pressure after 8 weeks treatment in the morning [1]
    End point description
    End point type
    Primary
    End point timeframe
    8 weeks
    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: Please see attached reference
    End point values
    		 Patients with glaucoma or ocular hypertension
    Number of subjects analysed
    16
    Units: mmHg
        arithmetic mean (standard deviation)
    24.3 ( 4.6 )
    No statistical analyses for this end point

    Primary: Intraocular pressure after 8 weeks treatment in the evening

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    End point title
    		 Intraocular pressure after 8 weeks treatment in the evening [2]
    End point description
    End point type
    Primary
    End point timeframe
    8 weeks
    Notes
    [2] - 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: Please see attached reference
    End point values
    		 Patients with glaucoma or ocular hypertension
    Number of subjects analysed
    16
    Units: mmHg
        arithmetic mean (standard deviation)
    21.9 ( 3.9 )
    No statistical analyses for this end point

    Secondary: Intraocular pressure after 4 weeks treatment in the morning

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    End point title
    		 Intraocular pressure after 4 weeks treatment in the morning
    End point description
    End point type
    Secondary
    End point timeframe
    4 weeks
    End point values
    		 Patients with glaucoma or ocular hypertension
    Number of subjects analysed
    16
    Units: mmHg
        arithmetic mean (standard deviation)
    24.4 ( 4.6 )
    No statistical analyses for this end point

    Secondary: Intraocular pressure after 4 weeks treatment in the evening

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    End point title
    		 Intraocular pressure after 4 weeks treatment in the evening
    End point description
    End point type
    Secondary
    End point timeframe
    4 weeks
    End point values
    		 Patients with glaucoma or ocular hypertension
    Number of subjects analysed
    16
    Units: mmHg
        arithmetic mean (standard deviation)
    21.6 ( 4.6 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    During the whole treatment period
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedlinePlus
    Dictionary version
    18.04.12
    Reporting groups
    Reporting group title
    Patients included in the study
    Reporting group description
    		 -

    Serious adverse events
    		 Patients included in the study
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 16 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Patients included in the study
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 16 (50.00%)
    Eye disorders
    Pruritus
    Additional description: Itching after instillation
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Hyperemia
    Additional description: Conjunctival hyperemia in both eyes
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Burning sensation
    Additional description: Burning after instillation
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Photophobia
    Additional description: Light sensitivity
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Blepharitis
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Common cold
         subjects affected / exposed
    2 / 16 (12.50%)
         occurrences all number
    2
    Rhinitis
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    2
    Skin and subcutaneous tissue disorders
    Gingivitis
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Stomal mucosa wound
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Exanthema and pruritus
    Additional description: Exanthema and pruritus (limbs)
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    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
    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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