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    Clinical Trial Results:
    Efficacy and safety assessment of T4032 (unpreserved bimatoprost 0.01%) versus Lumigan® 0.01% in ocular hypertensive or glaucomatous patients.

    Summary
    EudraCT number
    		 2017-000846-23
    Trial protocol
    		 FR   GB   DE   LT   GR   BE   PL   ES   SK   CZ   LV   BG   IT  
    Global end of trial date
    24 Feb 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Mar 2022
    First version publication date
    16 Mar 2022
    Other versions
    Summary report(s)
    		 LT4032-301_CSR synopsis

    Trial information

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    Trial identification
    Sponsor protocol code
    LT4032-301
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03825380
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Laboratoires Théa
    Sponsor organisation address
    12 Rue Louis Blériot, Clermont-Ferrand, France, 63017
    Public contact
    Clinical department, Laboratoires THEA, 0033 473981436, Aude.BARDIOT@theapharma.com
    Scientific contact
    Clinical department, Laboratoires THEA, 0033 473981436, Aude.BARDIOT@theapharma.com
    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
    13 Jul 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Feb 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Feb 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the non-inferiority of T4032 unpreserved Bimatoprost 0.01% eye drops compared to Lumigan® 0.01% in terms of efficacy.
    Protection of trial subjects
    Different assessments were done during subject visits in order to ensure subject safety: • Assessment of the conjunctival hyperaemia on McMonnies photographic scale in each eye. • Score of each ocular symptom throughout the day (irritation/burning, stinging, itching, tearing, eye dryness feeling, foreign body sensation) using 0-3 scale. • Score of each ocular symptom upon instillation (irritation/burning, stinging, itching, tearing, eye dryness feeling, foreign body sensation) using 0-3 scale. • Score of each ocular sign (blepharitis, eyelid oedema, iris pigmentation modification, abnormal eyelashes aspect, folliculo-papillary conjunctivitis, other ocular abnormality) in each eye using 0-3 scale. • Corneal fluorescein staining according to Oxford grading scheme in each eye. • Far Best Corrected Visual Acuity in each eye. • Ocular tolerance assessed by the investigator and by the patient. • Ocular and systemic AE reporting. All AEs experienced by a patient, irrespective of the suspected causality, was monitored until the event has resolved, any abnormal laboratory values have returned to baseline or stabilised at a level acceptable to the investigator and Medical expert, until there is a satisfactory explanation for the changes observed, or until the patient is lost to follow-up.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 Nov 2018
    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
    Canada: 7
    Country: Number of subjects enrolled
    Georgia: 12
    Country: Number of subjects enrolled
    Mauritius: 1
    Country: Number of subjects enrolled
    Russian Federation: 61
    Country: Number of subjects enrolled
    Tunisia: 36
    Country: Number of subjects enrolled
    Ukraine: 30
    Country: Number of subjects enrolled
    Poland: 47
    Country: Number of subjects enrolled
    Slovakia: 22
    Country: Number of subjects enrolled
    Spain: 28
    Country: Number of subjects enrolled
    United Kingdom: 1
    Country: Number of subjects enrolled
    Belgium: 8
    Country: Number of subjects enrolled
    Bulgaria: 80
    Country: Number of subjects enrolled
    Czechia: 40
    Country: Number of subjects enrolled
    Estonia: 14
    Country: Number of subjects enrolled
    France: 23
    Country: Number of subjects enrolled
    Germany: 8
    Country: Number of subjects enrolled
    Greece: 13
    Country: Number of subjects enrolled
    Hungary: 2
    Country: Number of subjects enrolled
    Italy: 25
    Country: Number of subjects enrolled
    Latvia: 20
    Country: Number of subjects enrolled
    Lithuania: 7
    Worldwide total number of subjects
    485
    EEA total number of subjects
    337
    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)
    251
    From 65 to 84 years
    226
    85 years and over
    8

    Subject disposition

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    Recruitment
    Recruitment details
    		 485 patients (from 723 screened patients) were included and randomised in the study: 485 patients in the intent-to-treat (ITT) set and Safety set, 469 in the modified ITT (mITT) set. The recruitment started on 23-NOV-2018 and was completed on 28-AUG-2020 and the last patient completed the study on 24-FEB-2021.

    Pre-assignment
    Screening details
    		 Incl/Excl criteria checked at screening visit, then patients discontinued their current treatment to start the run-in period with Azopt, for 5 weeks. The Azopt was stopped 1 or 2 weeks before the randomisation visit (Day 1). Incl/Excl criteria are confirmed at Day 1. 723 screened patients, 485 randomised patients, 238 screen failure patients.

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind [1]
    Roles blinded
    		 Investigator, Data analyst [2]
    Blinding implementation details
    blinded investigator and sponsor.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 T4032 arm
    Arm description
    		 The investigator-masked, 3-month T4032 treatment period lasted from the randomisation visit (Day 1; Visit #2) to the final Week 12 visit (Day 84±7 days; Visit #4). Test product: T4032 •Unpreserved bimatoprost 0.01% eye drops presented in unit dose (UD)
    Arm type
    		 Experimental

    Investigational medicinal product name
    T4032
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye gel in single-dose container
    Routes of administration
    Ocular use
    Dosage and administration details
    1 eyedrop in each eye at 20:00 every day

    Arm title
    		 Lumigan arm
    Arm description
    		 The investigator-masked, 3-month Lumigan treatment period lasted from the randomisation visit (Day 1; Visit #2) to the final Week 12 visit (Day 84±7 days; Visit #4). Reference product: Lumigan •Preserved bimatoprost 0.01% eye drops presented in multidose (MD) container
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Lumigan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops, solution
    Routes of administration
    Ocular use
    Dosage and administration details
    1 drop in each eye at 20:00 every day

    Notes
    [1] - The number of roles blinded appears inconsistent with a single blinded trial. It is expected that there will be one role blinded in a single blind trial.
    Justification: Subject is not blinded. The study is not considered as double blinded study. However investigator and data analyst are blinded.
    [2] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: Subject is not blinded. The study is not considered as double blinded study. However investigator and data analyst are blinded.
    Number of subjects in period 1
    		T4032 arm Lumigan arm
    Started
    236
    249
    Completed
    218
    227
    Not completed
    18
    22
         Consent withdrawn by subject
    1
    3
         Covid crisis
    10
    14
         Adverse event, non-fatal
    6
    4
         Lost to follow-up
    -
    1
         Lack of efficacy
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    T4032 arm
    Reporting group description
    		 The investigator-masked, 3-month T4032 treatment period lasted from the randomisation visit (Day 1; Visit #2) to the final Week 12 visit (Day 84±7 days; Visit #4). Test product: T4032 •Unpreserved bimatoprost 0.01% eye drops presented in unit dose (UD)

    Reporting group title
    Lumigan arm
    Reporting group description
    		 The investigator-masked, 3-month Lumigan treatment period lasted from the randomisation visit (Day 1; Visit #2) to the final Week 12 visit (Day 84±7 days; Visit #4). Reference product: Lumigan •Preserved bimatoprost 0.01% eye drops presented in multidose (MD) container

    Reporting group values
    		 T4032 arm Lumigan arm Total
    Number of subjects
    		 236 249 485
    Age categorical
    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)
    		 126 125 251
        From 65-84 years
    		 104 122 226
        85 years and over
    		 6 2 8
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 63.03 ( 11.85 ) 63.67 ( 10.92 ) -
    Gender categorical
    Units: Subjects
        Female
    		 141 153 294
        Male
    		 95 96 191
    Subject analysis sets

    Subject analysis set title
    Modified intention-to-treat T4032
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    T4032 arm - All randomised patients having received at least one dose of IMP (T4032 or Lumigan®), with at least one baseline and one post-randomisation efficacy assessment on treatment and considered as-randomised (i.e., according to the treatment unit assigned at Day 1). m-ITT set will be the primary population for efficacy analysis.

    Subject analysis set title
    Modified intention-to-treat Lumigan
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Lumigan arm - All randomised patients having received at least one dose of IMP (T4032 or Lumigan®), with at least one baseline and one post-randomisation efficacy assessment on treatment and considered as-randomised (i.e., according to the treatment unit assigned at Day 1). m-ITT set will be the primary population for efficacy analysis.

    Subject analysis sets values
    		 Modified intention-to-treat T4032 Modified intention-to-treat Lumigan
    Number of subjects
    229
    240
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
    124
    121
        From 65-84 years
    100
    117
        85 years and over
    5
    2
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    62.72 ( 11.80 )
    63.75 ( 11.00 )
    Gender categorical
    Units: Subjects
        Female
    137
    148
        Male
    92
    92

    End points

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    End points reporting groups
    Reporting group title
    T4032 arm
    Reporting group description
    		 The investigator-masked, 3-month T4032 treatment period lasted from the randomisation visit (Day 1; Visit #2) to the final Week 12 visit (Day 84±7 days; Visit #4). Test product: T4032 •Unpreserved bimatoprost 0.01% eye drops presented in unit dose (UD)

    Reporting group title
    Lumigan arm
    Reporting group description
    		 The investigator-masked, 3-month Lumigan treatment period lasted from the randomisation visit (Day 1; Visit #2) to the final Week 12 visit (Day 84±7 days; Visit #4). Reference product: Lumigan •Preserved bimatoprost 0.01% eye drops presented in multidose (MD) container

    Subject analysis set title
    Modified intention-to-treat T4032
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    T4032 arm - All randomised patients having received at least one dose of IMP (T4032 or Lumigan®), with at least one baseline and one post-randomisation efficacy assessment on treatment and considered as-randomised (i.e., according to the treatment unit assigned at Day 1). m-ITT set will be the primary population for efficacy analysis.

    Subject analysis set title
    Modified intention-to-treat Lumigan
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Lumigan arm - All randomised patients having received at least one dose of IMP (T4032 or Lumigan®), with at least one baseline and one post-randomisation efficacy assessment on treatment and considered as-randomised (i.e., according to the treatment unit assigned at Day 1). m-ITT set will be the primary population for efficacy analysis.

    Primary: Change in Intraocular Pressure (IOP) between Day 1 and Week 12 at 8:00 in the worse eye.

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    End point title
    		 Change in Intraocular Pressure (IOP) between Day 1 and Week 12 at 8:00 in the worse eye.
    End point description
    The primary endpoint was defined as the change in IOP between Day 1 and Week 12 at 8:00, 10:00 and 16:00 in the worse eye, therefore 3 definitions needed for describing the primary endpoint. Three independent mixed model with repeated measures (MMRM) were performed, one for each time point (8:00, 10:00 and 16:00). Least Squares (LS) means were adjusted by baseline IOP, wash-out duration as continuous covariates and country, visit and treatment group as categorical fixed effects, as well as visit interaction with treatment group and visit interaction with baseline IOP group, using the restricted maximum likelihood (REML) and unstructured covariance matrix. The worse eye was defined as the eligible eye with the highest IOP at Day 1 at 8:00. In case of no IOP difference between both eyes, the right eye was considered as the worse eye.
    End point type
    Primary
    End point timeframe
    Baseline, Week 12 at 8:00.
    End point values
    		 Modified intention-to-treat T4032 Modified intention-to-treat Lumigan
    Number of subjects analysed
    229
    239
    Units: mmHg
        least squares mean (standard error)
    -9.67 ( 0.19 )
    -9.50 ( 0.18 )
    Statistical analysis title
    		 Analysis of change from BSL in IOP at 8:00 at Wk12
    Statistical analysis description
    Primary analysis of the change from baseline in IOP (mmHg) at 8:00 at Week 12 - MMRM analysis – Worse eye - m-ITT set
    Comparison groups
    Modified intention-to-treat Lumigan v Modified intention-to-treat T4032
    Number of subjects included in analysis
    468
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 Adjusted mean difference
    Point estimate
    -0.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.62
         upper limit
    		 0.28
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.23
    Notes
    [1] - Noninferiority was demonstrated if the upper bound of the two-sided 95% Confidence Interval (CI) for the difference in mean change in IOP between treatment groups (T4032 - Lumigan) was lower than the margin of +1.5 mmHg for each of the 3 time points 8:00, 10:00 and 16:00.

    Primary: Change in Intraocular Pressure (IOP) between Day 1 and Week 12 at 10:00 in the worse eye.

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    End point title
    		 Change in Intraocular Pressure (IOP) between Day 1 and Week 12 at 10:00 in the worse eye.
    End point description
    The primary endpoint was defined as the change in IOP between Day 1 and Week 12 at 8:00, 10:00 and 16:00 in the worse eye, therefore 3 definitions needed for describing the primary endpoint. Three independent mixed model with repeated measures (MMRM) were performed, one for each time point (8:00, 10:00 and 16:00). Least Squares (LS) means were adjusted by baseline IOP, wash-out duration as continuous covariates and country, visit and treatment group as categorical fixed effects, as well as visit interaction with treatment group and visit interaction with baseline IOP group, using the restricted maximum likelihood (REML) and unstructured covariance matrix. The worse eye was defined as the eligible eye with the highest IOP at Day 1 at 8h00. In case of no IOP difference between both eyes, the right eye was considered as the worse eye
    End point type
    Primary
    End point timeframe
    Baseline, Week 12 at 10:00
    End point values
    		 Modified intention-to-treat T4032 Modified intention-to-treat Lumigan
    Number of subjects analysed
    229
    240
    Units: mmHg
        least squares mean (standard error)
    -9.41 ( 0.18 )
    -9.26 ( 0.17 )
    Statistical analysis title
    		 Analysis change from BSL in IOP at 10:00 at Wk12
    Statistical analysis description
    Primary analysis of the change from baseline in IOP (mmHg) at 10:00 at Week 12 - MMRM analysis – Worse eye - m-ITT set
    Comparison groups
    Modified intention-to-treat Lumigan v Modified intention-to-treat T4032
    Number of subjects included in analysis
    469
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    Method
    Parameter type
    		 Adjusted mean difference
    Point estimate
    -0.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.58
         upper limit
    		 0.27
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.22
    Notes
    [2] - Noninferiority was demonstrated if the upper bound of the two-sided 95% Confidence Interval (CI) for the difference in mean change in IOP between treatment groups (T4032 - Lumigan) was lower than the margin of +1.5 mmHg for each of the 3 time points 8:00, 10:00 and 16:00.

    Primary: Change in Intraocular Pressure (IOP) between Day 1 and Week 12 at 16:00 in the worse eye.

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    End point title
    		 Change in Intraocular Pressure (IOP) between Day 1 and Week 12 at 16:00 in the worse eye.
    End point description
    The primary endpoint was defined as the change in IOP between Day 1 and Week 12 at 8:00, 10:00 and 16:00 in the worse eye, therefore 3 definitions needed for describing the primary endpoint. Three independent mixed model with repeated measures (MMRM) were performed, one for each time point (8:00, 10:00 and 16:00). Least Squares (LS) means were adjusted by baseline IOP, wash-out duration as continuous covariates and country, visit and treatment group as categorical fixed effects, as well as visit interaction with treatment group and visit interaction with baseline IOP group, using the restricted maximum likelihood (REML) and unstructured covariance matrix. The worse eye was defined as the eligible eye with the highest IOP at Day 1 at 8h00. In case of no IOP difference between both eyes, the right eye was considered as the worse eye.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1), Week 12 at 16:00
    End point values
    		 Modified intention-to-treat T4032 Modified intention-to-treat Lumigan
    Number of subjects analysed
    229
    239
    Units: mmHg
        least squares mean (standard error)
    -8.97 ( 0.18 )
    -8.78 ( 0.18 )
    Statistical analysis title
    		 Analysis change from BSL in IOP at 16:00 at Wk12
    Statistical analysis description
    Primary analysis of the change from baseline in IOP (mmHg) at 16:00 at Week 12 - MMRM analysis – Worse eye - m-ITT set
    Comparison groups
    Modified intention-to-treat T4032 v Modified intention-to-treat Lumigan
    Number of subjects included in analysis
    468
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    Method
    Parameter type
    		 Adjusted mean difference
    Point estimate
    -0.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.61
         upper limit
    		 0.23
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.22
    Notes
    [3] - Noninferiority was demonstrated if the upper bound of the two-sided 95% Confidence Interval (CI) for the difference in mean change in IOP between treatment groups (T4032 - Lumigan) was lower than the margin of +1.5 mmHg for each of the 3 time points 8:00, 10:00 and 16:00.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse event reporting extends from start of the treatment until Day 112 follow-up phone call.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    T4032
    Reporting group description
    		 The investigator-masked, 3-month treatment period lasted from the randomisation visit (Day 1; Visit#2) to the final Week 12 visit (Day 84±7 days; Visit #4). Test product: T4032 •Unpreserved bimatoprost 0.01% eye drops presented in unit dose (UD)

    Reporting group title
    Lumigan
    Reporting group description
    		 The investigator-masked, 3-month Lumigan treatment period lasted from the randomisation visit (Day 1; Visit #2) to the final Week 12 visit (Day 84±7 days; Visit #4). Reference product: Lumigan •Preserved bimatoprost 0.01% eye drops presented in multidose (MD)

    Serious adverse events
    		 T4032 Lumigan
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 236 (0.42%)
    2 / 249 (0.80%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 236 (0.42%)
    0 / 249 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    0 / 236 (0.00%)
    1 / 249 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 236 (0.00%)
    1 / 249 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 T4032 Lumigan
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    13 / 236 (5.51%)
    17 / 249 (6.83%)
    Eye disorders
    Conjunctival hyperaemia
         subjects affected / exposed
    13 / 236 (5.51%)
    17 / 249 (6.83%)
         occurrences all number
    13
    17

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Jul 2019
    On 05-JUL-2019 a new protocol version (Version 3.0) was created with the following updates: -Increase the number of countries and sites involved in the study -Extension of the study duration -Increase of the planned number of screened patients: 668 instead of 434 -Prolongation of the run-in/wash-out period: 49 days instead of 42 days, including 2 weeks ofwash-out instead of 1 week -Clarification regarding premature discontinuation visit -Clarification regarding analysis (efficacy analysis – washout duration)

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    18 Mar 2020
    The World Health Organization (WHO) declared on Wednesday, 11 March 2020 that the Covid-19 epidemic is now considered a pandemic. To stop the Covid-19 spread, governmental authorities have implemented restrictive measures (closure of borders and shops, self-isolation of people …). The situation is evolving quickly and measures differ in each country. In this exceptional, unexpected situation that could affect the benefit/risk ratio of the clinical trial, Laboratoires Théa decided to: - Temporary stop recruitment - Temporary stop onsite monitoring visits. Please note that for already included patients, the decision to continue the study according to the protocol requirements or to withdraw the patient will be assessed by the investigator and based on the regulatory situation in the concerned country.
    27 May 2020

    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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