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    Clinical Trial Results:
    Evaluation of inflammatory markers in patients on topical anti-glaucoma drop therapy; a comparative trial of preserved and non-preserved primary medical treatment (eye drops) in patients with glaucoma and ocular hypertension – a pilot study.

    Summary
    EudraCT number
    		 2013-000581-10
    Trial protocol
    		 GB  
    Global end of trial date
    02 Nov 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 May 2020
    First version publication date
    30 May 2020
    Other versions
    Summary report(s)
    		 Ocular Surface Study - End of Study report

    Trial information

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    Trial identification
    Sponsor protocol code
    12OY006
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Nottingham University NHS Hospitals Trust
    Sponsor organisation address
    Queens Medical Centre, Derby Road, Nottingham, United Kingdom, NG7 2UH
    Public contact
    R&I, Nottingham University Hospitals NHS Trust, +44 115 9249924, researchsponsor@nuh.nhs.uk
    Scientific contact
    R&I, Nottingham University NHS Hospitals Trust, +44 115 9249924 , researchsponsor@nuh.nhs.uk
    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
    31 Aug 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Aug 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Nov 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary outcome: To evaluate the expression of inflammatory markers in the tear film and on the ocular surface of patients undergoing treatment for glaucoma and ocular hypertension using drops containing different types of preservative or no preservative. Secondary Outcome: Trabecular Meshwork (TMW) endothelium cell health following exposure to different preservative regimes Clinical Outcomes: Ocular surface disease index (OSDI) assessment Biomarker outcomes: 1.identification of tear, ocular surface and tissue expression of biomarkers of inflammation between patients using preserved and preservative free medical treatment for glaucoma and the control participants 2.quantification of changes in biomarker expression between different treatment modalities. 3.quantification and identification of profile changes in inflammatory biomarker expression over time and with different drop regimes
    Protection of trial subjects
    None.
    Background therapy
    		 None.
    Evidence for comparator
    		 Treatment-naïve glaucoma patients requiring topical hypotensive medication were enrolled and randomized into three groups each receiving benzalkonium chloride (BAK), polyquad (PQ) or preservative free (PF).
    Actual start date of recruitment
    01 May 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
    United Kingdom: 38
    Worldwide total number of subjects
    38
    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)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    13
    From 65 to 84 years
    24
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 Potential trial participants with ocular hypertension or glaucoma requiring drop treatment were recruited from the glaucoma service at Nottingham University Hospitals from 09/07/2014 to 31/01/2017.

    Pre-assignment
    Screening details
    		 Newly diagnosed patients with glaucoma and ocular hypertension attending the glaucoma service were sent an invitation letter over a 12 month period.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Masking of patients or clinicians to treatment was not possible. However, IC and tear samples were masked to group allocation and the analysis of biomarkers was undertaken in a masked fashion.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Benzalkonium chloride (BAK)
    Arm description
    		 Benzalkonium chloride arm - preserved eye drops
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Bimatoprost
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops
    Routes of administration
    Ocular use
    Dosage and administration details
    xxx

    Arm title
    		 Polyquad (PQ)
    Arm description
    		 Polyquad preservative arm
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Travaprost
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops
    Routes of administration
    Ocular use
    Dosage and administration details
    0.04% Once daily preferably in the evening

    Investigational medicinal product name
    Travaprost + Timolol (Duotrav)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops
    Routes of administration
    Ocular use
    Dosage and administration details
    0.04%/ml plus 0.5%/ml Once daily

    Investigational medicinal product name
    Travaprost
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops
    Routes of administration
    Ocular use
    Dosage and administration details
    0.04% once daily preferably in the evening.

    Arm title
    		 Preservative free
    Arm description
    		 Preservative free arm
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Latanoprost
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops
    Routes of administration
    Ocular use
    Dosage and administration details
    0.005% Once daily preferably in the evening

    Number of subjects in period 1 [1]
    		Benzalkonium chloride (BAK) Polyquad (PQ) Preservative free
    Started
    7
    8
    8
    Baseline
    7
    8
    8
    1 month
    7
    8
    8
    3 months
    7
    8
    8
    6 months
    7
    8
    8
    12 months
    7
    8
    8
    24 months
    7
    8
    8
    Completed
    7
    8
    8
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Please see end of study report.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Benzalkonium chloride (BAK)
    Reporting group description
    		 Benzalkonium chloride arm - preserved eye drops

    Reporting group title
    Polyquad (PQ)
    Reporting group description
    		 Polyquad preservative arm

    Reporting group title
    Preservative free
    Reporting group description
    		 Preservative free arm

    Reporting group values
    		 Benzalkonium chloride (BAK) Polyquad (PQ) Preservative free Total
    Number of subjects
    		 7 8 8 23
    Age categorical
    Of the 38 original participants 13 participants were between the ages of 18 and 64. The youngest of these was 46 years of age, 24 participants were between the ages of 65 and 84 and there was just one patient who was 85 and over. The oldest participant in this study was 86 years of age.
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 3 2 4 9
        From 65-84 years
    		 4 5 4 13
        85 years and over
    		 0 1 0 1
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 61 (46 to 76) 68 (50 to 86) 65 (56 to 74) -
    Gender categorical
    See End of study report
    Units: Subjects
        Female
    		 3 6 3 12
        Male
    		 4 2 5 11
    Subject analysis sets

    Subject analysis set title
    Benzalkonium (BAK)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Benzalkonium preserved eyedrops

    Subject analysis set title
    Polyquad (PQ)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Preserved eye drop

    Subject analysis set title
    Preservative free
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Preservative free eyedrop

    Subject analysis sets values
    		 Benzalkonium (BAK) Polyquad (PQ) Preservative free
    Number of subjects
    7
    8
    8
    Age categorical
    Of the 38 original participants 13 participants were between the ages of 18 and 64. The youngest of these was 46 years of age, 24 participants were between the ages of 65 and 84 and there was just one patient who was 85 and over. The oldest participant in this study was 86 years of age.
    Units: Subjects
        In utero
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    0
        Children (2-11 years)
    0
    0
    0
        Adolescents (12-17 years)
    0
    0
    0
        Adults (18-64 years)
    3
    2
    4
        From 65-84 years
    4
    5
    4
        85 years and over
    0
    1
    0
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    65 (56 to 74)
    61 (46 to 76)
    68 (50 to 86)
    Gender categorical
    See End of study report
    Units: Subjects
        Female
    3
    6
    3
        Male
    4
    2
    5

    End points

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    End points reporting groups
    Reporting group title
    Benzalkonium chloride (BAK)
    Reporting group description
    		 Benzalkonium chloride arm - preserved eye drops

    Reporting group title
    Polyquad (PQ)
    Reporting group description
    		 Polyquad preservative arm

    Reporting group title
    Preservative free
    Reporting group description
    		 Preservative free arm

    Subject analysis set title
    Benzalkonium (BAK)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Benzalkonium preserved eyedrops

    Subject analysis set title
    Polyquad (PQ)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Preserved eye drop

    Subject analysis set title
    Preservative free
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Preservative free eyedrop

    Primary: Cytokine Results

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    End point title
    		 Cytokine Results [1]
    End point description
    The expression of inflammatory markers in the tear film, on the ocular surface and on the conjunctiva and Tenons’ tissue of patients undergoing treatment for glaucoma using drops containing different types of preservative or no preservative.
    End point type
    Primary
    End point timeframe
    24 months
    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: Full statistical analysis can be found in the attached End of Study report.
    End point values
    		 Benzalkonium (BAK) Polyquad (PQ) Preservative free
    Number of subjects analysed
    Units: decimals
        arithmetic mean (standard deviation)
    83.34 ± 55.63
    1119.40 ± 674.68
    2.06 ± 5.65
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Non serious adverse events did not have a specified timeframe for reporting. Serious adverse events were required to be reported within 24 hours of participating site becoming aware of the event.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16
    Frequency threshold for reporting non-serious adverse events: 5%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No adverse events of any kind were reported please see attached end of study report.

    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.
    1. Recruitment was not to time and target and therefore the study may be underpowered to show affect. 2. Neither the patients nor the clinicians were masked to treatment allocation. 3 Significant number of samples were not adequate for analysis
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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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