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    Clinical Trial Results:
    Open, Observer-blind, two Parallel Group, Randomized, Multicentric Clinical Phase III Trial on the Comparison of Efficacy and Tolerability of a New Preservative-free Formulation of the Fixed Combination Latanoprost 50 µg/ml and Timolol 5 mg/ml Eye Drops vs. Xalacom? Eye Drops in Patients with Primary Open Angle Glaucoma or Ocular Hypertension

    Summary
    EudraCT number
    		 2011-005339-15
    Trial protocol
    		 ES  
    Global end of trial date
    05 Mar 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Apr 2021
    First version publication date
    12 Apr 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    QTM/OMN0211
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    OmniVision GmbH
    Sponsor organisation address
    Lindberghstraße 9, Puchheim, Germany, 82178
    Public contact
    Sponsor, OmniVision GmbH, clinicalconsultant@omnivision.de
    Scientific contact
    Sponsor, OmniVision GmbH, clinicalconsultant@omnivision.de
    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
    02 Apr 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Mar 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To confirm the clinical non-inferiority of the preservative-free fixed combination Latanoprost/ Timolol eye drops compared with the marketed preservative-containing Xalacom? eye drops by the average decrease of diurnal IOP measured between the first and last visit
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Jan 2012
    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
    Spain: 165
    Worldwide total number of subjects
    165
    EEA total number of subjects
    165
    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)
    165
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 All patients provided written informed consent to participate in the study prior to being screened. At screening, IOP evaluation was performed by two separate measurements one hour apart to confirm the eligibility of the patient concerning the inclusion criterion IOP ≤21 mmHg. 170 patients were assessed for eligibility, 165 were randomized.

    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
    Blinding implementation details
    The clinical trial was performed as observer-blind because of the differences in the packaging of both drugs. The investigational medicinal product is a preservative-free preparation, which has a special container closure system. Patients and non-blind personnel were cautioned not to reveal the clinical trial assignment to the blind evaluator.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Latanoprost 50 µg/ml and Timolol 5 mg/ml
    Arm description
    		 New Preservative-free Formulation of the Fixed Combination Latanoprost 50 µg/ml and Timolol 5 mg/ml Eye Drops
    Arm type
    		 Experimental

    Investigational medicinal product name
    preservative-free combination of Latanoprost (50 µg/ml), Timolol (5 µg/ml)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops
    Routes of administration
    Topical use
    Dosage and administration details
    Dose: One drop in each eye once daily in the evening at 21:00 (± 15 minutes)

    Arm title
    		 Xalacom
    Arm description
    		 The current preparations of Xalacom™ contain latanoprost 50 micrograms, 6.8 mg timolol maleate equivalent to 5 mg timolol and 200 microgram of the excipient benzalkonium chloride (BAC) in 1ml solution.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Xalacom™ (Pfizer)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops
    Routes of administration
    Topical use
    Dosage and administration details
    Dose: One drop in each eye once daily in the evening at 21:00 (± 15 minutes)

    Number of subjects in period 1
    		Latanoprost 50 µg/ml and Timolol 5 mg/ml Xalacom
    Started
    82
    83
    Completed
    73
    75
    Not completed
    9
    8
         Did not receive allocated intervention
    1
    -
         Lost to follow-up
    8
    8

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Latanoprost 50 µg/ml and Timolol 5 mg/ml
    Reporting group description
    		 New Preservative-free Formulation of the Fixed Combination Latanoprost 50 µg/ml and Timolol 5 mg/ml Eye Drops

    Reporting group title
    Xalacom
    Reporting group description
    		 The current preparations of Xalacom™ contain latanoprost 50 micrograms, 6.8 mg timolol maleate equivalent to 5 mg timolol and 200 microgram of the excipient benzalkonium chloride (BAC) in 1ml solution.

    Reporting group values
    		 Latanoprost 50 µg/ml and Timolol 5 mg/ml Xalacom Total
    Number of subjects
    		 82 83 165
    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)
    		 66.961 ( 9.5297 ) 65.824 ( 12.3016 ) -
    Gender categorical
    Units: Subjects
        Female
    		 53 51 104
        Male
    		 20 24 44
        Not recorded
    		 9 8 17

    End points

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    End points reporting groups
    Reporting group title
    Latanoprost 50 µg/ml and Timolol 5 mg/ml
    Reporting group description
    		 New Preservative-free Formulation of the Fixed Combination Latanoprost 50 µg/ml and Timolol 5 mg/ml Eye Drops

    Reporting group title
    Xalacom
    Reporting group description
    		 The current preparations of Xalacom™ contain latanoprost 50 micrograms, 6.8 mg timolol maleate equivalent to 5 mg timolol and 200 microgram of the excipient benzalkonium chloride (BAC) in 1ml solution.

    Subject analysis set title
    Difference_evaluation
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Non inferiority of diurnal intraocular pressure difference between baseline and end of treatment (day 28) for the investigational drug compared with the comparator have been calculated. To calculate non inferiority, treatment difference and a two-sided 95% confidence interval (CI) for the difference have been calculated.

    Primary: Diurnal IOP difference between baseline and end of treatment (day 28)

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    End point title
    		 Diurnal IOP difference between baseline and end of treatment (day 28) [1]
    End point description
    Non inferiority of diurnal intraocular pressure difference between baseline and end of treatment (day 28) for the investigational drug compared with the comparator have been calculated. To calculate non inferiority, treatment difference and a two-sided 95% confidence interval (CI) for the difference have been calculated . The preservative-free fixed composition of Latanoprost/Timolol eye drops is considered to be non-inferior to the marketed Xalacom™ including preservative because the upper limit of the 95% CI of the difference is <1.5 mmHg. To be reported: the difference between both eyes intraocular pressure measured after 28 days of treatment with Latanoprost/Timolol versus Xalacom (covariate: initial intraocular pressure).
    End point type
    Primary
    End point timeframe
    difference between baseline and end of treatment (day 28)
    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: Due to missing data concerning the statistical analysis this section cannot be completed.
    End point values
    		 Difference_evaluation
    Number of subjects analysed
    148
    Units: mmHg
        arithmetic mean (confidence interval 95%)
    0.317 (-0.198 to 0.832)
    No statistical analyses for this end point

    Secondary: Average decrease of diurnal IOP measured between baseline and day 7

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    End point title
    		 Average decrease of diurnal IOP measured between baseline and day 7
    End point description
    End point type
    Secondary
    End point timeframe
    From baseline to day 7.
    End point values
    		 Latanoprost 50 µg/ml and Timolol 5 mg/ml Xalacom
    Number of subjects analysed
    73
    75
    Units: mmHg
    arithmetic mean (standard error)
        Mean IOP day 1
    17.562 ( 0.226 )
    17.988 ( 0.223 )
        Mean IOP day 7
    17.217 ( 0.237 )
    17.342 ( 0.234 )
    No statistical analyses for this end point

    Secondary: Average decrease of diurnal IOP measured between baseline and day 14

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    End point title
    		 Average decrease of diurnal IOP measured between baseline and day 14
    End point description
    End point type
    Secondary
    End point timeframe
    From baseline to day 14.
    End point values
    		 Latanoprost 50 µg/ml and Timolol 5 mg/ml Xalacom
    Number of subjects analysed
    73
    75
    Units: mmHg
    arithmetic mean (standard error)
        Mean IOP day 1
    17.562 ( 0.226 )
    17.988 ( 0.223 )
        Mean IOP day 7
    17.217 ( 0.237 )
    17.342 ( 0.234 )
        Mean IOP day 14
    17.210 ( 0.221 )
    17.444 ( 0.218 )
    No statistical analyses for this end point

    Secondary: Proportion of patients with measured IOP <21 mmHg at the end of study (week 4)

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    End point title
    		 Proportion of patients with measured IOP <21 mmHg at the end of study (week 4)
    End point description
    End point type
    Secondary
    End point timeframe
    At the end of the study.
    End point values
    		 Latanoprost 50 µg/ml and Timolol 5 mg/ml Xalacom
    Number of subjects analysed
    82
    83
    Units: percent
    number (not applicable)
        percent
    100
    100
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All adverse events (AEs) that occurred during the study were documented.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 not specified
    Dictionary version
    N/A
    Reporting groups
    Reporting group title
    Latanoprost/Timolol
    Reporting group description
    		 -

    Reporting group title
    Xalacom
    Reporting group description
    		 -

    Serious adverse events
    		 Latanoprost/Timolol Xalacom
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 83 (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: 0%
    Non-serious adverse events
    		 Latanoprost/Timolol Xalacom
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 81 (3.70%)
    1 / 83 (1.20%)
    Injury, poisoning and procedural complications
    Trauma
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 83 (1.20%)
         occurrences all number
    0
    1
    Eye disorders
    Gritty sensation in the left eye
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 83 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 83 (0.00%)
         occurrences all number
    1
    0
    Stomach discomfort
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 83 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 83 (0.00%)
         occurrences all number
    1
    0
    irritative cough
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 83 (1.20%)
         occurrences all number
    0
    1
    Hepatobiliary disorders
    Headache
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 83 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Pruritus on face
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 83 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Influenza
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 83 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Apr 2012
    V1. 1-03-2012 New Sites included: H. San Carlos, H. Reina Sofía
    10 May 2012
    V2. 2-04-2012 New Sites included: Puerta del Mar, V. Macarena, Carlos Haya, Torrecárdenas, Virgen de las Nieves
    10 Oct 2012
    V3. 8-08-2012 Change in a Inclusion Criterion
    13 Dec 2012
    V4. 22-10-2012 New Sites included: H. La Paz, H. La Fe, ICR
    07 Mar 2013
    V5. 17-01-2013 New Principal Investigator of Torrecárdenas hospital
    09 May 2013
    V6. 4-04-2013 New sites included: H. Morales Meseguer, H. de La Vega

    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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