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    Clinical Trial Results:
    Multi-centre, randomised, double blind, placebo-controlled, parallel, phase III study to assess the safety, tolerability and efficacy of bilastine ophthalmic solution 0.6% in adults

    Summary
    EudraCT number
    		 2018-002248-95
    Trial protocol
    		 LT   HU   SK   PL  
    Global end of trial date
    10 Dec 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Aug 2021
    First version publication date
    20 Aug 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BOFT-0418-SAFE
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    FAES FARMA S.A.
    Sponsor organisation address
    Avda. Autornomía, 10, Leioa, Spain, 48940
    Public contact
    R&D+i Department, Irune Temprano , FAES FARMA S.A., +34 944818300, itemprano@faes.es
    Scientific contact
    R&D+i Department, Nieves Fernández, FAES FARMA S.A., +34 944818300, nfernandez@faes.es
    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
    10 Dec 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Dec 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Dec 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this trial is to assess the safety of bilastine ophthalmic solution 0.6% during long-term use.
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Patients, adopted by the General Assembly of the World Medical Association, Fortaleza, Brazil 2013 as well as with the valid national law(s) of the participating country/ies, with the International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice (GCP) (E6), and with the Commission Directives 2001/20/EC and 2005/28/EC. Additionally, the trial was conducted in compliance with the trial protocol, by trial personnel, who were qualified by education, training, and experienced in their roles. The patients were closely monitored during the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Jun 2019
    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
    Ukraine: 76
    Country: Number of subjects enrolled
    Poland: 111
    Country: Number of subjects enrolled
    Slovakia: 47
    Country: Number of subjects enrolled
    Hungary: 49
    Country: Number of subjects enrolled
    Lithuania: 50
    Worldwide total number of subjects
    333
    EEA total number of subjects
    257
    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)
    321
    From 65 to 84 years
    12
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 At screening, after giving informed consent, the patients were checked for elegibility. Patients were randomised to IMP only if they satisfied all the inclusion criteria and were not precluded from participation by any of the exclusion criteria.

    Pre-assignment
    Screening details
    		 In this trial, 333 adult patients with seasonal or perennial allergic conjunctivitis were included and randomised on a 2:1 ratio (stratified by indication [SAC/PAC]) to treatment with bilastine ophthalmic solution 0.6% or placebo for 56 days.

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Arm title
    		 Overall population
    Arm description
    		 Participants were randomised to receive treatment with bilastine ophthalmic solution 0.6% or placebo for 56 days. All randomised patients received at least one dose of IMP.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bilastine ophtalmic solution 0,6%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops, solution
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    1 drop instilled in each eye once daily in the morning.

    Investigational medicinal product name
    Placebo ophtalmic solution
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops, solution
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    1 drop instilled in each eye once daily in the morning.

    Number of subjects in period 1
    		Overall population
    Started
    333
    Completed
    320
    Not completed
    13
         Adverse event, non-fatal
    13

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall study (overall period)
    Reporting group description
    		 Participants were randomised to receive treatment with bilastine ophthalmic solution 0.6% or placebo for 56 days. All randomised patients received at least one dose of IMP.

    Reporting group values
    		 Overall study (overall period) Total
    Number of subjects
    		 333 333
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 321 321
        From 65-84 years
    		 12 12
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 39 ± 13.66 -
    Gender categorical
    Units: Subjects
        Female
    		 212 212
        Male
    		 121 121
    Subject analysis sets

    Subject analysis set title
    Bilastine ophtalmic solution 0,6%
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety analysis set includes all randomised patients with IMP administration (bilastine ophtalmic solution or placebo). Data from all 333 subjects were included in the safety evaluation.

    Subject analysis set title
    Placebo ophtalmic solution
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety analysis set includes all randomised patients with IMP administration (bilastine ophtalmic solution or placebo). Data from all 333 subjects were included in the safety evaluation.

    Subject analysis sets values
    		 Bilastine ophtalmic solution 0,6% Placebo ophtalmic solution
    Number of subjects
    218
    115
    Age categorical
    Units: Subjects
        In utero
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
        Newborns (0-27 days)
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
        Children (2-11 years)
    0
    0
        Adolescents (12-17 years)
    0
    0
        Adults (18-64 years)
    210
    111
        From 65-84 years
    8
    4
        85 years and over
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    39.4 ± 14.01
    38.4 ± 13.01
    Gender categorical
    Units: Subjects
        Female
    149
    63
        Male
    69
    52

    End points

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    End points reporting groups
    Reporting group title
    Overall population
    Reporting group description
    		 Participants were randomised to receive treatment with bilastine ophthalmic solution 0.6% or placebo for 56 days. All randomised patients received at least one dose of IMP.

    Subject analysis set title
    Bilastine ophtalmic solution 0,6%
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety analysis set includes all randomised patients with IMP administration (bilastine ophtalmic solution or placebo). Data from all 333 subjects were included in the safety evaluation.

    Subject analysis set title
    Placebo ophtalmic solution
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety analysis set includes all randomised patients with IMP administration (bilastine ophtalmic solution or placebo). Data from all 333 subjects were included in the safety evaluation.

    Primary: Incidence of related treatment-emergent ocular adverse events (ocular r-TEAEs)

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    End point title
    		 Incidence of related treatment-emergent ocular adverse events (ocular r-TEAEs) [1]
    End point description
    Incidence (percent of patients) of related treatment-emergent ocular adverse events (ocular r-TEAEs).
    End point type
    Primary
    End point timeframe
    The period for evaluating ocular r-TEAEs started when the study drug was administered and ended with last follow-up.
    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: No statistical analyses were performed for the comparison of ocular r-TEAE incidences between the two treatment groups due to the low numbers of TEAEs in relation to the sample size.
    End point values
    		 Overall population Bilastine ophtalmic solution 0,6% Placebo ophtalmic solution
    Number of subjects analysed
    333
    218
    115
    Units: Percent of patients
    number (not applicable)
        Dry eye
    1.2
    0.9
    1.7
        Eye discharge
    0.6
    0.9
    0
        Eye irritation
    0.6
    0.5
    0.9
        Conjunctivitis allergic
    0.3
    0
    0.9
        Eye pruritus
    0.3
    0
    0.9
        Lacrimation increased
    0.3
    0.5
    0
        Ocular discomfort
    0.3
    0.5
    0
        Patients with at least one ocular r-TEAE
    3.3
    2.8
    4.3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The period for evaluating adverse events started when the study drug was administered and ended with last follow-up.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    Bilastine ophtalmic solution 0.6%
    Reporting group description
    		 Adverse events occured during Bilastine ophtalmic solution 0.6% administration

    Reporting group title
    Placebo ophtalmic solution
    Reporting group description
    		 Adverse events occured during Placebo ophtalmic solution administration

    Reporting group title
    Overall population
    Reporting group description
    		 -

    Serious adverse events
    		 Bilastine ophtalmic solution 0.6% Placebo ophtalmic solution Overall population
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 218 (0.00%)
    0 / 115 (0.00%)
    0 / 333 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Bilastine ophtalmic solution 0.6% Placebo ophtalmic solution Overall population
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    28 / 218 (12.84%)
    18 / 115 (15.65%)
    46 / 333 (13.81%)
    Vascular disorders
    Vascular disorders
         subjects affected / exposed
    1 / 218 (0.46%)
    1 / 115 (0.87%)
    2 / 333 (0.60%)
         occurrences all number
    1
    1
    2
    General disorders and administration site conditions
    General disorders and administration site conditions
         subjects affected / exposed
    1 / 218 (0.46%)
    0 / 115 (0.00%)
    1 / 333 (0.30%)
         occurrences all number
    1
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Respiratory, thoracic and mediastinal disorders
         subjects affected / exposed
    1 / 218 (0.46%)
    2 / 115 (1.74%)
    3 / 333 (0.90%)
         occurrences all number
    1
    2
    3
    Investigations
    Investigations
         subjects affected / exposed
    1 / 218 (0.46%)
    0 / 115 (0.00%)
    1 / 333 (0.30%)
         occurrences all number
    1
    0
    1
    Injury, poisoning and procedural complications
    Injury, poisoning and procedural complications
         subjects affected / exposed
    2 / 218 (0.92%)
    1 / 115 (0.87%)
    3 / 333 (0.90%)
         occurrences all number
    2
    1
    3
    Cardiac disorders
    Cardiac disorders
         subjects affected / exposed
    0 / 218 (0.00%)
    1 / 115 (0.87%)
    1 / 333 (0.30%)
         occurrences all number
    0
    1
    1
    Nervous system disorders
    Nervous system disorders
         subjects affected / exposed
    4 / 218 (1.83%)
    0 / 115 (0.00%)
    4 / 333 (1.20%)
         occurrences all number
    5
    0
    5
    Ear and labyrinth disorders
    Ear and labyrinth disorders
         subjects affected / exposed
    1 / 218 (0.46%)
    0 / 115 (0.00%)
    1 / 333 (0.30%)
         occurrences all number
    1
    0
    1
    Eye disorders
    Eye disorders
         subjects affected / exposed
    12 / 218 (5.50%)
    6 / 115 (5.22%)
    18 / 333 (5.41%)
         occurrences all number
    15
    6
    21
    Gastrointestinal disorders
    Gastrointestinal disorders
         subjects affected / exposed
    2 / 218 (0.92%)
    1 / 115 (0.87%)
    3 / 333 (0.90%)
         occurrences all number
    3
    1
    4
    Skin and subcutaneous tissue disorders
    Skin and subcutaneous tissue disorders
         subjects affected / exposed
    1 / 218 (0.46%)
    2 / 115 (1.74%)
    3 / 333 (0.90%)
         occurrences all number
    2
    2
    4
    Musculoskeletal and connective tissue disorders
    Musculoskeletal and connective tissue disorders
         subjects affected / exposed
    1 / 218 (0.46%)
    0 / 115 (0.00%)
    1 / 333 (0.30%)
         occurrences all number
    1
    0
    1
    Infections and infestations
    Infections and infestations
         subjects affected / exposed
    7 / 218 (3.21%)
    6 / 115 (5.22%)
    13 / 333 (3.90%)
         occurrences all number
    7
    7
    14
    Metabolism and nutrition disorders
    Metabolism and nutrition disorders
         subjects affected / exposed
    0 / 218 (0.00%)
    1 / 115 (0.87%)
    1 / 333 (0.30%)
         occurrences all number
    0
    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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