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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 children

    Summary
    EudraCT number
    		 2020-002098-86
    Trial protocol
    		 ES  
    Global end of trial date
    30 Nov 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Apr 2024
    First version publication date
    05 Apr 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BOFT-0520/PED
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 PIP number: EMEA-000347-PIP02-16
    Sponsors
    Sponsor organisation name
    FAES FARMA, S.A.
    Sponsor organisation address
    Avda. Autonomía, 10, Leioa (Bizkaia), Spain, 48940
    Public contact
    Inmaculada Gilaberte, FAES FARMA, S.A., 0034 944818300,
    Scientific contact
    Inmaculada Gilaberte, FAES FARMA, S.A., 0034 944818300,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000347-PIP02-16
    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
    05 Oct 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Nov 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the safety of Bilastine ophthalmic solution 0.6% during long-term use in children
    Protection of trial subjects
    This clinical trial was conducted in accordance with the protocol, the principles established in the current revised version of the Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects (Fortaleza, Brazil; October 2013), the Harmonized Tripartite Guidelines for Good Clinical Practice, and applicable regulatory requirements. The study was not started until approval by the ethics committee and other pertinent authorities was obtained. By signing the protocol, the investigator agreed to adhere to the instructions and procedures described in the protocol and, therefore, to comply with the principles of good clinical practice they entail. Eligible patients were only included in the study after providing written (witnessed, where required by law or regulation), IEC-approved informed consent, or, if incapable of doing so, after such consent was provided by a legally acceptable representative of the patient. In cases where the patient’s representative gave consent, the patient was informed about the study to the extent possible, given his/her understanding. Informed consent was obtained before conducting any study-specific procedures (i.e., all procedures described in the protocol). The process of obtaining informed consent was documented in the patient's source documents.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Feb 2021
    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: 65
    Worldwide total number of subjects
    65
    EEA total number of subjects
    65
    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)
    50
    Adolescents (12-17 years)
    15
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Between March 2021 and November 2022, a total of 65 patients were enrolled in this trial, of which 6 were considered screening failures. Fifty-nine (59) patients were finally randomized: 42 to bilastine group and 17 to placebo group, which formed the Full Analysis population.

    Pre-assignment
    Screening details
    		 This study has been performed in children and adolescent patients aged 2 to under 18 years with a documented history of SAC and/or PAC, documented positive skin prick test and/or positive validated IgE test to seasonal and/or perennial allergen within 6 months before, and signs and symptoms of AC that are likely to continue for the next weeks.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    Treatment was double-blind. Bilastine ophthalmic solution 0.6% and placebo were identical in color and appearance. The packaging and labelling did not allow for any distinction between the test and the reference drug. No person involved in conducting the clinical trial was allowed to have access to the randomisation code before the blind was officially broken. Unblinding was not done unless an actual emergency occurred, and knowledge of the patient’s treatment affected his/her medical treatment.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Bilastine ophthalmic solution 0.6%
    Arm description
    		 In this clinical trial, patients aged 2 to under 18 years with AC could be included and randomised in a 2:1 ratio to treatment with Bilastine ophthalmic solution 0.6% or placebo for 57 days. Patients were divided into cohorts by age (2 to under 6 years [Coh.1], 6 to under 12 years [Coh. 2], 12 to under 18 years [Coh. 3]). Patients were also stratified by indication (SAC or PAC), but no minimum or balanced number of patients in each subgroup was required for analysis.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BIlastine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops, solution
    Routes of administration
    Ocular use
    Dosage and administration details
    The active substance in this study was Bilastine ophthalmic solution 0.6% (6 mg/mL), 1 drop instilled in each eye once daily.

    Arm title
    		 Placebo ophthalmic solution
    Arm description
    		 In this clinical trial, patients aged 2 to under 18 years with AC could be included and randomised in a 2:1 ratio to treatment with Bilastine ophthalmic solution 0.6% or placebo for 57 days. Patients were divided into cohorts by age (2 to under 6 years [Coh.1], 6 to under 12 years [Coh. 2], 12 to under 18 years [Coh. 3]). Patients were also stratified by indication (SAC or PAC), but no minimum or balanced number of patients in each subgroup was required for analysis.
    Arm type
    		 Placebo

    Investigational medicinal product name
    ophthalmic solution
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops, solution
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    The reference therapy in this study was Placebo ophthalmic solution 1 drop instilled in each eye once daily.

    Number of subjects in period 1 [1]
    		Bilastine ophthalmic solution 0.6% Placebo ophthalmic solution
    Started
    42
    17
    Completed
    34
    12
    Not completed
    8
    5
         Consent withdrawn by subject
    1
    1
         Adverse event, non-fatal
    3
    2
         Other reasons
    1
    1
         Lost to follow-up
    -
    1
         Use of prohibited concomitant medications
    2
    -
         Lack of efficacy
    1
    -
    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: There were 6 patients who were considered screening failures: 2 patients did not meet at least one of the inclusion criteria, 1 patient met at least one of the exclusion criteria, 1 patient withdrawal of informed consent, and 2 patients for other reasons.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Bilastine ophthalmic solution 0.6%
    Reporting group description
    		 In this clinical trial, patients aged 2 to under 18 years with AC could be included and randomised in a 2:1 ratio to treatment with Bilastine ophthalmic solution 0.6% or placebo for 57 days. Patients were divided into cohorts by age (2 to under 6 years [Coh.1], 6 to under 12 years [Coh. 2], 12 to under 18 years [Coh. 3]). Patients were also stratified by indication (SAC or PAC), but no minimum or balanced number of patients in each subgroup was required for analysis.

    Reporting group title
    Placebo ophthalmic solution
    Reporting group description
    		 In this clinical trial, patients aged 2 to under 18 years with AC could be included and randomised in a 2:1 ratio to treatment with Bilastine ophthalmic solution 0.6% or placebo for 57 days. Patients were divided into cohorts by age (2 to under 6 years [Coh.1], 6 to under 12 years [Coh. 2], 12 to under 18 years [Coh. 3]). Patients were also stratified by indication (SAC or PAC), but no minimum or balanced number of patients in each subgroup was required for analysis.

    Reporting group values
    		 Bilastine ophthalmic solution 0.6% Placebo ophthalmic solution Total
    Number of subjects
    		 42 17 59
    Age categorical
    Units: Subjects
        Cohort 1 (≥2, <6)
    		 4 2 6
        Cohort 2 (≥6, <12)
    		 28 11 39
        Cohort 3 (≥12, <18)
    		 10 4 14
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 10.4 ± 2.69 9.3 ± 3.76 -
    Gender categorical
    Units: Subjects
        Female
    		 19 3 22
        Male
    		 23 14 37
    Race
    Units: Subjects
        White
    		 30 13 43
        Asian
    		 1 1 2
        Black
    		 2 0 2
        Other
    		 9 3 12
    Type of allergic conjunctivitis
    Units: Subjects
        Perennial allergic conjunctivitis (PAC)
    		 31 14 45
        Seasonal allergic conjunctivitis (SAC)
    		 11 3 14

    End points

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    End points reporting groups
    Reporting group title
    Bilastine ophthalmic solution 0.6%
    Reporting group description
    		 In this clinical trial, patients aged 2 to under 18 years with AC could be included and randomised in a 2:1 ratio to treatment with Bilastine ophthalmic solution 0.6% or placebo for 57 days. Patients were divided into cohorts by age (2 to under 6 years [Coh.1], 6 to under 12 years [Coh. 2], 12 to under 18 years [Coh. 3]). Patients were also stratified by indication (SAC or PAC), but no minimum or balanced number of patients in each subgroup was required for analysis.

    Reporting group title
    Placebo ophthalmic solution
    Reporting group description
    		 In this clinical trial, patients aged 2 to under 18 years with AC could be included and randomised in a 2:1 ratio to treatment with Bilastine ophthalmic solution 0.6% or placebo for 57 days. Patients were divided into cohorts by age (2 to under 6 years [Coh.1], 6 to under 12 years [Coh. 2], 12 to under 18 years [Coh. 3]). Patients were also stratified by indication (SAC or PAC), but no minimum or balanced number of patients in each subgroup was required for analysis.

    Primary: Patients with at least one ocular r-TEAE

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    End point title
    		 Patients with at least one ocular r-TEAE [1]
    End point description
    End point type
    Primary
    End point timeframe
    Throughout the study.
    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: There is no statistical analyses for the primary endpoint since it is a descriptive analyses.
    End point values
    		 Bilastine ophthalmic solution 0.6% Placebo ophthalmic solution
    Number of subjects analysed
    42
    17
    Units: patients
    0
    1
    No statistical analyses for this end point

    Secondary: Patients with at least one TEAE

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    End point title
    		 Patients with at least one TEAE
    End point description
    End point type
    Secondary
    End point timeframe
    Throughout the study.
    End point values
    		 Bilastine ophthalmic solution 0.6% Placebo ophthalmic solution
    Number of subjects analysed
    42
    17
    Units: patients with at least one event
    10
    4
    No statistical analyses for this end point

    Secondary: Patients with at least one ocular TEAE

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    End point title
    		 Patients with at least one ocular TEAE
    End point description
    End point type
    Secondary
    End point timeframe
    Throughout the study.
    End point values
    		 Bilastine ophthalmic solution 0.6% Placebo ophthalmic solution
    Number of subjects analysed
    42
    17
    Units: patients
    7
    3
    No statistical analyses for this end point

    Secondary: Patients with at least one r-TEAE

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    End point title
    		 Patients with at least one r-TEAE
    End point description
    End point type
    Secondary
    End point timeframe
    Throughout the study
    End point values
    		 Bilastine ophthalmic solution 0.6% Placebo ophthalmic solution
    Number of subjects analysed
    42
    17
    Units: patients
    0
    1
    No statistical analyses for this end point

    Secondary: Incidence of clinically abnormal findings in opthalmic examinations

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    End point title
    		 Incidence of clinically abnormal findings in opthalmic examinations
    End point description
    Clinical significant (CS) abnormal finding
    End point type
    Secondary
    End point timeframe
    Visit 1a and visit 5b.
    End point values
    		 Bilastine ophthalmic solution 0.6% Placebo ophthalmic solution
    Number of subjects analysed
    42 [2]
    17 [3]
    Units: Number of CS abnormal findings
    number (not applicable)
        Best-Corrected Visual Acuity, V1a (N1=41; N2=17)
    0
    0
        Best-Corrected Visual Acuity, V5b (N1=34; N2=12)
    0
    0
        Slit lamp (Cornea), V1a (N1=82; N2=34)
    4
    0
        Slit lamp (Cornea), V5b (N1=68; N2=24)
    0
    2
        Slit lamp (Conjunctiva), V1a (N1=82; N2=34)
    28
    10
        Slit lamp (Conjunctiva), V5b (N1=68; N2=24)
    15
    6
        Slit lamp (Crystalline lens), V1a (N1=82; N2=34)
    0
    0
        Slit lamp (Crystalline lens), V5b (N1=68; N2=24)
    0
    0
        Slit lamp (Eyelid), V1a (N1=82; N2=34)
    3
    0
        Slit lamp (Eyelid), V5b (N1=68; N2=24
    0
    0
        Slit lamp (Ant. chamber), V1a (N1=82; N2=34)
    0
    0
        Slit lamp (Ant. chamber), V5b (N1=68; N2=24)
    0
    0
    Notes
    [2] - Number of patients indicated in every visit. N1: bilastine arm; N2: placebo arm.
    [3] - Number of patients indicated in every visit. N1: bilastine arm; N2: placebo arm.
    No statistical analyses for this end point

    Secondary: Intraocular pressure (IOP)

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    End point title
    		 Intraocular pressure (IOP)
    End point description
    End point type
    Secondary
    End point timeframe
    V1a and V5b
    End point values
    		 Bilastine ophthalmic solution 0.6% Placebo ophthalmic solution
    Number of subjects analysed
    42 [4]
    17 [5]
    Units: mmHg
    arithmetic mean (standard deviation)
        V1a (N1=35; N2=12)
    14.71 ± 2.197
    16.25 ± 2.454
        V5b (N1=29; N2=9)
    14.45 ± 2.273
    14.72 ± 2.293
    Notes
    [4] - Number of patients indicated in every visit. N1: bilastine arm; N2: placebo arm.
    [5] - Number of patients indicated in every visit. N1: bilastine arm; N2: placebo arm.
    No statistical analyses for this end point

    Secondary: Peak ocular discomfort

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    End point title
    		 Peak ocular discomfort
    End point description
    Patients with no or slight ocular discomfort (scores 0-2). V1b_0= immediately after IMP; V1b_+1= 1 minute after IMP; V1b_+5= 5 minutes after IMP; V5a_0= immediately after IMP; V5a_+1= 1 minute after IMP; V5a_+5= 5 minutes after IMP.
    End point type
    Secondary
    End point timeframe
    V1b and V5a
    End point values
    		 Bilastine ophthalmic solution 0.6% Placebo ophthalmic solution
    Number of subjects analysed
    42 [6]
    17 [7]
    Units: Percentage of patients
    number (not applicable)
        V1b_0 (N1=42; N2=17)
    78.5
    82.3
        V1b_+1 (N1=42; N2=17)
    92.9
    100
        V1b_+5 (N1=42; N2=17)
    92.9
    100
        V5a_0 (N1=32; N2=12)
    87.5
    100
        V5a_+1 (N1=32; N2=12)
    87.5
    100
        V5a_+5 (N1=32; N2=12)
    87.5
    100
    Notes
    [6] - Number of patients indicated in every visit. N1: bilastine arm; N2: placebo arm.
    [7] - Number of patients indicated in every visit. N1: bilastine arm; N2: placebo arm.
    No statistical analyses for this end point

    Secondary: Ocular Tolerability

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    End point title
    		 Ocular Tolerability
    End point description
    Patients with no or slight ocular symptoms (scores from 0-2).
    End point type
    Secondary
    End point timeframe
    V1b and V5a
    End point values
    		 Bilastine ophthalmic solution 0.6% Placebo ophthalmic solution
    Number of subjects analysed
    42 [8]
    17 [9]
    Units: percentage of patients
    number (not applicable)
        Burning, V1b (N1=42; N2=17)
    88
    94.2
        Burning, V5a (N1=33; N2= 12)
    90.9
    100
        Stinging, V1b (N1=42; N2=17)
    87.5
    94.2
        Stinging, V5a (N1=33; N2= 12)
    97
    100
        Tearing, V1b (N1=42; N2=17)
    92.8
    88.3
        Tearing, V5a (N1=33; N2= 12)
    90.9
    91.7
        Blurring, V1b (N1=42; N2=17)
    95.2
    94.1
        Blurring, V5a (N1=33; N2= 12)
    96.9
    100
        Stickiness, V1b (N1=42; N2=17)
    90.5
    94.1
        Stickiness, V5a (N1=33; N2= 12)
    87.9
    75
    Notes
    [8] - Number of patients indicated in every visit. N1: bilastine arm; N2: placebo arm.
    [9] - Number of patients indicated in every visit. N1: bilastine arm; N2: placebo arm.
    No statistical analyses for this end point

    Secondary: Summary of TESS

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    End point title
    		 Summary of TESS
    End point description
    End point type
    Secondary
    End point timeframe
    8-weeks study period
    End point values
    		 Bilastine ophthalmic solution 0.6% Placebo ophthalmic solution
    Number of subjects analysed
    42 [10]
    17 [11]
    Units: Score
    arithmetic mean (standard deviation)
        Baseline (N1=42; N2=17)
    18.7 ± 5.25
    19.0 ± 5.06
        Overall (N1=38; N2=16)
    4.5 ± 4.22
    3.8 ± 4.16
    Notes
    [10] - Number of patients indicated in every visit. N1: bilastine arm; N2: placebo arm.
    [11] - Number of patients indicated in every visit. N1: bilastine arm; N2: placebo arm.
    Statistical analysis title
    		 MMRM Analysis
    Comparison groups
    Bilastine ophthalmic solution 0.6% v Placebo ophthalmic solution
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.651
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.556
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.897
         upper limit
    		 3.009

    Secondary: Absolute Change from Baseline

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    End point title
    		 Absolute Change from Baseline
    End point description
    End point type
    Secondary
    End point timeframe
    8-weeks study period
    End point values
    		 Bilastine ophthalmic solution 0.6% Placebo ophthalmic solution
    Number of subjects analysed
    38
    16
    Units: score
        arithmetic mean (standard deviation)
    -15.7 ± 9.53
    -15.4 ± 5.22
    Statistical analysis title
    		 MMRM Analysis
    Comparison groups
    Bilastine ophthalmic solution 0.6% v Placebo ophthalmic solution
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.651
    Method
    		 Mixed models analysis
    Parameter type
    		 Median difference (final values)
    Point estimate
    0.556
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.897
         upper limit
    		 3.009

    Secondary: Relative Change from Baseline (%)

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    End point title
    		 Relative Change from Baseline (%)
    End point description
    End point type
    Secondary
    End point timeframe
    8-weeks study period
    End point values
    		 Bilastine ophthalmic solution 0.6% Placebo ophthalmic solution
    Number of subjects analysed
    38
    16
    Units: percentage
        arithmetic mean (standard deviation)
    -76.2 ± 21.61
    -81.0 ± 20.13
    Statistical analysis title
    		 MMRM Analysis
    Comparison groups
    Bilastine ophthalmic solution 0.6% v Placebo ophthalmic solution
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.447
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    4.943
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.01
         upper limit
    		 17.895

    Secondary: Summary of TESS from baseline at each week

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    End point title
    		 Summary of TESS from baseline at each week
    End point description
    End point type
    Secondary
    End point timeframe
    8-weeks period
    End point values
    		 Bilastine ophthalmic solution 0.6% Placebo ophthalmic solution
    Number of subjects analysed
    42 [12]
    17 [13]
    Units: Score
    arithmetic mean (standard deviation)
        Baseline (N1=42; N2=17)
    18.7 ± 5.25
    19.0 ± 5.06
        Week 1 (N1=36; N2=15)
    5.4 ± 4.86
    5.9 ± 6.31
        Week 2 (N1=37; N2=12)
    5.8 ± 5.90
    3.1 ± 3.42
        Week 3 (N1=36; N2=14)
    4.6 ± 5.14
    2.7 ± 3.73
        Week 4 (N1=34; N2=12)
    4.0 ± 4.45
    2.7 ± 3.31
        Week 5 (N1=33; N2=12)
    3.1 ± 3.65
    2.4 ± 3.34
        Week 6 (N1=27; N2=11)
    2.9 ± 3.36
    2.1 ± 3.05
        Week 7 (N1=27; N2=11)
    2.6 ± 3.19
    2.8 ± 3.21
        Week 8 (N1=28; N2=12)
    2.5 ± 3.33
    2.5 ± 3.79
    Notes
    [12] - Number of patients indicated in every visit. N1: bilastine arm; N2: placebo arm.
    [13] - Number of patients indicated in every visit. N1: bilastine arm; N2: placebo arm.
    No statistical analyses for this end point

    Secondary: Absolute change from baseline week

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    End point title
    		 Absolute change from baseline week
    End point description
    End point type
    Secondary
    End point timeframe
    8-week study period
    End point values
    		 Bilastine ophthalmic solution 0.6% Placebo ophthalmic solution
    Number of subjects analysed
    36
    14
    Units: score
    arithmetic mean (standard deviation)
        Week 1
    -13.3 ± 7.03
    -13.1 ± 6.33
        Week 2
    -12.8 ± 6.95
    -15.1 ± 4.03
        Week 3
    -13.9 ± 6.53
    -16.3 ± 4.60
        Week 4
    -14.7 ± 6.36
    -15.5 ± 4.05
        Week 5
    -15.6 ± 6.47
    -15.9 ± 3.90
        Week 6
    -16.1 ± 5.87
    -16.2 ± 4.27
        Week 7
    -16.4 ± 5.05
    -15.5 ± 5.48
        Week 8
    -15.7 ± 9.53
    -15.4 ± 5.22
    No statistical analyses for this end point

    Secondary: Relative change from baseline week (%)

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    End point title
    		 Relative change from baseline week (%)
    End point description
    End point type
    Secondary
    End point timeframe
    8-weeks study period
    End point values
    		 Bilastine ophthalmic solution 0.6% Placebo ophthalmic solution
    Number of subjects analysed
    36
    15
    Units: percentage
    arithmetic mean (standard deviation)
        Week 1
    -68.3 ± 30.49
    -69.7 ± 30.32
        Week 2
    -67.7 ± 30.60
    -84.5 ± 13.25
        Week 3
    -74.6 ± 27.11
    -87.4 ± 15.10
        Week 4
    -78.0 ± 23.72
    -86.7 ± 12.20
        Week 5
    -81.5 ± 22.45
    -88.9 ± 12.93
        Week 6
    -84.1 ± 18.96
    -90.3 ± 12.32
        Week 7
    -86.8 ± 14.74
    -84.6 ± 14.84
        Week 8
    -86.9 ± 14.97
    -87.2 ± 16.85
    No statistical analyses for this end point

    Secondary: Ocular Symptom Scores (Itching)

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    End point title
    		 Ocular Symptom Scores (Itching)
    End point description
    End point type
    Secondary
    End point timeframe
    8-week study period
    End point values
    		 Bilastine ophthalmic solution 0.6% Placebo ophthalmic solution
    Number of subjects analysed
    42 [14]
    17 [15]
    Units: score
    arithmetic mean (standard deviation)
        Baseline (N1=42; N2=17)
    6.5 ± 1.90
    6.5 ± 2.00
        Overall (N1=38; N2=16)
    1.8 ± 1.48
    1.5 ± 1.93
    Notes
    [14] - Number of patients indicated in every visit. N1: bilastine arm; N2: placebo arm.
    [15] - Number of patients indicated in every visit. N1: bilastine arm; N2: placebo arm.
    No statistical analyses for this end point

    Secondary: Ocular Symptom Scores (Redness)

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    End point title
    		 Ocular Symptom Scores (Redness)
    End point description
    End point type
    Secondary
    End point timeframe
    8-weeks study period
    End point values
    		 Bilastine ophthalmic solution 0.6% Placebo ophthalmic solution
    Number of subjects analysed
    42 [16]
    17 [17]
    Units: score
    arithmetic mean (standard deviation)
        Baseline (N1=42; N2=17)
    6.5 ± 1.89
    7.0 ± 2.32
        Overall (N1=38; N2=16)
    1.8 ± 1.71
    1.4 ± 1.31
    Notes
    [16] - Number of patients indicated in every visit. N1: bilastine arm; N2: placebo arm.
    [17] - Number of patients indicated in every visit. N1: bilastine arm; N2: placebo arm.
    No statistical analyses for this end point

    Secondary: Ocular Symptom Scores (Tearing)

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    End point title
    		 Ocular Symptom Scores (Tearing)
    End point description
    End point type
    Secondary
    End point timeframe
    8-weeks study period
    End point values
    		 Bilastine ophthalmic solution 0.6% Placebo ophthalmic solution
    Number of subjects analysed
    42 [18]
    17 [19]
    Units: score
    arithmetic mean (standard deviation)
        Baseline (N1=42; N2=17)
    5.8 ± 2.7
    5.5 ± 3.1
        Overall (N1=38; N2=16)
    1.1 ± 1.31
    1.0 ± 1.21
    Notes
    [18] - Number of patients indicated in every visit. N1: bilastine arm; N2: placebo arm.
    [19] - Number of patients indicated in every visit. N1: bilastine arm; N2: placebo arm.
    No statistical analyses for this end point

    Secondary: Absolute Change from Baseline

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    End point title
    		 Absolute Change from Baseline
    End point description
    End point type
    Secondary
    End point timeframe
    8-weeks study
    End point values
    		 Bilastine ophthalmic solution 0.6% Placebo ophthalmic solution
    Number of subjects analysed
    38
    16
    Units: score
    arithmetic mean (standard deviation)
        Itching
    -4.8 ± 2.31
    -5.0 ± 2.65
        Redness
    -4.6 ± 2.30
    -5.6 ± 2.12
        Tearing
    -4.7 ± 2.77
    -4.8 ± 2.77
    No statistical analyses for this end point

    Secondary: Relative Change from Baseline (%)

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    End point title
    		 Relative Change from Baseline (%)
    End point description
    End point type
    Secondary
    End point timeframe
    8-weeks study
    End point values
    		 Bilastine ophthalmic solution 0.6% Placebo ophthalmic solution
    Number of subjects analysed
    38
    16
    Units: percentage
    number (not applicable)
        Itching
    -70.5
    -76.4
        Redness
    -71.2
    -77.4
        Tearing
    -78.1
    -82.2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    8-weeks study period
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    Safety population (Bilastine)
    Reporting group description
    		 -

    Reporting group title
    Safety population (Placebo)
    Reporting group description
    		 -

    Serious adverse events
    		 Safety population (Bilastine) Safety population (Placebo)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 17 (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: 1%
    Non-serious adverse events
    		 Safety population (Bilastine) Safety population (Placebo)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 42 (23.81%)
    4 / 17 (23.53%)
    Injury, poisoning and procedural complications
    Allergy to vaccine
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Surgical and medical procedures
    Tonsillectomy
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    2 / 42 (4.76%)
    1 / 17 (5.88%)
         occurrences all number
    2
    1
    Blepharitis
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Conjunctival hyperaemia
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Eye irritation
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Eyelid oedema
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Ocular discomfort
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Ocular hyperaemia
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Scleral oedema
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    1 / 42 (2.38%)
    1 / 17 (5.88%)
         occurrences all number
    1
    1
    H1N1 influenza
         subjects affected / exposed
    1 / 42 (2.38%)
    1 / 17 (5.88%)
         occurrences all number
    1
    1
    Conjunctivitis
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 17 (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
    04 Dec 2020
    Expansion of participating sites. Changes to the financial report.
    24 Feb 2021
    Expansion of participating sites.
    23 Jun 2021
    Expansion of participating sites.
    29 Dec 2021
    Expansion of participating sites. Changes to the financial report.

    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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