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    Clinical Trial Results:
    A prospective, observer-masked, randomized clinical trial to investigate and compare the clinical efficacy of chloroprocaine 3% gel and tetracaine 0.5% eye drop as topical anesthetics in phacoemulsification.

    Summary
    EudraCT number
    		 2019-001660-30
    Trial protocol
    		 SK   ES   IT  
    Global end of trial date
    09 Mar 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 May 2022
    First version publication date
    19 May 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CHL.3/01-2019/M
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04685538
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sintetica SA
    Sponsor organisation address
    Via Penate 5, Mendrisio, Switzerland, 6850
    Public contact
    Clinical Operations, Iris Pharma, +33 493594959,
    Scientific contact
    Clinical Operations, Iris Pharma, +33 493594959,
    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
    03 Nov 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Mar 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Equivalence evaluation of Test versus Reference products in terms of proportion of subjects with a successful surface anesthesia for cataract surgery, without any supplementation at T4 (just before Intra Ocular Lens implantation) Successful surface anesthesia & Supplementation are defined in the study protocol.
    Protection of trial subjects
    For ensuring the protection of the subjects, inclusion and exclusion criteria were assessed at visit 1 for and the proper safety assessemtn and adverse evente collection thoughout the whole study duration.
    Background therapy
    		 not applicable
    Evidence for comparator
    		 Current practices for ocular topical anesthesia in Europe include topical liquid Oxybuprocaine, Tetracaine and Lidocaine. Tetracaine was chosen among them.
    Actual start date of recruitment
    27 Apr 2020
    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
    Slovakia: 130
    Country: Number of subjects enrolled
    Spain: 17
    Country: Number of subjects enrolled
    Italy: 263
    Worldwide total number of subjects
    410
    EEA total number of subjects
    410
    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)
    112
    From 65 to 84 years
    282
    85 years and over
    16

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients scheduled to undergo cataract surgery in a single eye at a time fo a day surgery

    Pre-assignment
    Screening details
    		 Visit 1: between Day -90 and Day -1 ICF;Verification of incl/excl criteria, demography data;pregnancy test;Ocular and systemic medical and surgical histories;Previous and ConMeds;Ocular symptoms;Best-far corrected visual acuity;Slit lamp examination;IOP;Endothelial cell count;Fundoscopy;Pachymetry;Macular optical coherence tomography;CV parameters

    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
    This was a masked-observer study. The surgeon placing the gel/drop was aware of the treatment administered. He/she was not to be further involved in patient’s care, and data recording and all the study variables were to be evaluated and recorded by another investigator The surgeon was to be only involved in patient surgery and in satisfaction assessment. An independent masked investigator was to evaluate sensory block and safety parameters for each patient. The patient was to be masked.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Chloroprocaine
    Arm description
    		 Chloroprocaine 3% Gel ophthalmic gel
    Arm type
    		 Experimental

    Investigational medicinal product name
    Chloroprocaine hydrochloride 3% eye gel
    Investigational medicinal product code
    CAS number: 3858-89-7
    Other name
    Pharmaceutical forms
    Eye gel
    Routes of administration
    Conjunctival use
    Dosage and administration details
    Dose: 1 drop Frequency: 3 times Administration route: Topical instillation

    Arm title
    		 Tetracaine
    Arm description
    		 Tetracaine 0.5% eye-drop ophthalmic solution
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Tetracaine 0.5% eye-drop ophthalmic solution
    Investigational medicinal product code
    NDC 69292-0317-15
    Other name
    Pharmaceutical forms
    Eye drops, solution
    Routes of administration
    Conjunctival use
    Dosage and administration details
    Dose: 1 drop Frequency: 3 times Administration route: Topical instillation

    Number of subjects in period 1
    		Chloroprocaine Tetracaine
    Started
    205
    205
    Completed
    163
    169
    Not completed
    42
    36
         Adverse event, non-fatal
    -
    1
         not randomized
    -
    32
         discontinuated before treatment
    32
    -
         discontinued before treatment
    -
    1
         Lost to follow-up
    -
    2
         Protocol deviation
    10
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 Number of patients enrolled and randomized to receive either IMP or active comparator

    Reporting group values
    		 overall trial Total
    Number of subjects
    		 410 410
    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)
    		 112 112
        From 65-84 years
    		 282 282
        85 years and over
    		 16 16
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 69.37 ( 10.11 ) -
    Gender categorical
    Units: Subjects
        Female
    		 228 228
        Male
    		 182 182
    Subject analysis sets

    Subject analysis set title
    Enrolled set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All patients enrolled in the study.

    Subject analysis set title
    FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All patients enrolled in the study for whom any follow-up efficacy information was available.

    Subject analysis set title
    Safety set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All patients enrolled in the study, for whom there was evidence that they used study medication and for whom any follow-up information was available

    Subject analysis set title
    PP set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    ll patients of the FAS who did not show any major protocol violation.

    Subject analysis sets values
    		 Enrolled set FAS Safety set PP set
    Number of subjects
    410
    338
    338
    332
    Age categorical
    Units: Subjects
        In utero
    0
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    0
    0
        Children (2-11 years)
    0
    0
    0
    0
        Adolescents (12-17 years)
    0
    0
    0
    0
        Adults (18-64 years)
    112
    85
    85
    85
        From 65-84 years
    282
    239
    239
    237
        85 years and over
    16
    13
    13
    12
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    69.37 ( 10.11 )
    69.58 ( 10.12 )
    69.58 ( 10.12 )
    69.56 ( 10.12 )
    Gender categorical
    Units: Subjects
        Female
    228
    180
    180
    176
        Male
    182
    158
    158
    156

    End points

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    End points reporting groups
    Reporting group title
    Chloroprocaine
    Reporting group description
    		 Chloroprocaine 3% Gel ophthalmic gel

    Reporting group title
    Tetracaine
    Reporting group description
    		 Tetracaine 0.5% eye-drop ophthalmic solution

    Subject analysis set title
    Enrolled set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All patients enrolled in the study.

    Subject analysis set title
    FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All patients enrolled in the study for whom any follow-up efficacy information was available.

    Subject analysis set title
    Safety set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All patients enrolled in the study, for whom there was evidence that they used study medication and for whom any follow-up information was available

    Subject analysis set title
    PP set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    ll patients of the FAS who did not show any major protocol violation.

    Primary: Successful surface anesthesia_Chloroprocaine vs Tetracaine

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    End point title
    		 Successful surface anesthesia_Chloroprocaine vs Tetracaine
    End point description
    Equivalence evaluation of Chloroprocaine 3% Gel versus Tetracaine 0.5% eye-drop products in terms of proportion of patients with a successful surface anesthesia for cataract surgery, without any supplementation at T4 (just before Intra Ocular Lens implantation).
    End point type
    Primary
    End point timeframe
    at T4 in Visit 2
    End point values
    		 Chloroprocaine Tetracaine
    Number of subjects analysed
    163 [1]
    169 [2]
    Units: number of subjects
        Anesthesia Success_PP_Yes
    150
    153
        Anesthesia Success_PP_No
    13
    16
        Anesthesia Success_FAS_Yes
    152
    153
        Anesthesia Success_FAS_No
    14
    19
    Attachments
    		 Untitled (Filename: surface anesthesia at T4_V2.png)
    Notes
    [1] - 163 for the PP 166 for the FAS
    [2] - 169 for the PP 172 for the FAS
    Statistical analysis title
    		 Proportion of successful surface anesthesia at T4
    Comparison groups
    Tetracaine v Chloroprocaine
    Number of subjects included in analysis
    332
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 estimated difference in proportions
    Point estimate
    1.5
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -10
         upper limit
    		 10
    Variability estimate
    Standard deviation

    Secondary: Successful surface anesthesia at T1, T2, T3 during Visit 2_PP

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    End point title
    		 Successful surface anesthesia at T1, T2, T3 during Visit 2_PP
    End point description
    Time points: T1 - Just before first incision T2 - End of capsulorhexis T3 - End of phacoemulsification
    End point type
    Secondary
    End point timeframe
    during Visit 2
    End point values
    		 Chloroprocaine Tetracaine
    Number of subjects analysed
    163
    169
    Units: number of subjects
        Successful surface anesthesia_T1_Yes
    155
    163
        Successful surface anesthesia_T1_No
    8
    6
        Successful surface anesthesia_T2_Yes
    159
    163
        Successful surface anesthesia_T2_No
    4
    6
        Successful surface anesthesia_T3_Yes
    152
    151
        Successful surface anesthesia_T3_No
    11
    18
    No statistical analyses for this end point

    Secondary: Ocular symptoms analysis - Safety set

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    End point title
    		 Ocular symptoms analysis - Safety set
    End point description
    Ocular symptoms (pain, irritation/burning/stinging, photophobia, foreign body sensation) will be graded by the patients according to the following scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe.
    End point type
    Secondary
    End point timeframe
    during the study (Visit 1-Selection and Visit 4-Final)
    End point values
    		 Chloroprocaine Tetracaine
    Number of subjects analysed
    166
    172 [3]
    Units: grading
    arithmetic mean (standard deviation)
        Foreign body sensation_V1_study eye
    0.08 ( 0.32 )
    0.06 ( 0.33 )
        Foreign body sensation_V4_study eye
    0.19 ( 0.43 )
    0.17 ( 0.41 )
        Irritation/burning/stinging_V1_study eye
    0.11 ( 0.33 )
    0.11 ( 0.37 )
        Irritation/burning/stinging_V4_study eye
    0.11 ( 0.36 )
    0.15 ( 0.39 )
        Pain_V1_study eye
    0.01 ( 0.11 )
    0.01 ( 0.08 )
        Pain_V4_study eye
    0.05 ( 0.24 )
    0.05 ( 0.24 )
        Photophobia_V1_study eye
    0.13 ( 0.42 )
    0.08 ( 0.35 )
        Photophobia_V4_study eye
    0.18 ( 0.50 )
    0.11 ( 0.36 )
    Notes
    [3] - 169 for all the assessment at visit 4
    No statistical analyses for this end point

    Secondary: Time to obtain sufficient anesthesia and total time (duration) of anesthesia_PP

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    End point title
    		 Time to obtain sufficient anesthesia and total time (duration) of anesthesia_PP
    End point description
    Note: For patients who achieved anesthesia in a time frame of less than a minute, time to obtain anesthesia is set at 1 min.
    End point type
    Secondary
    End point timeframe
    at visit 2
    End point values
    		 Chloroprocaine Tetracaine
    Number of subjects analysed
    163
    169
    Units: minute
    arithmetic mean (standard deviation)
        Time To Obtain Sufficient Anesthesia
    1.35 ( 0.87 )
    1.57 ( 1.85 )
        Total Duration Of Anesthesia
    21.57 ( 12.26 )
    22.04 ( 12.58 )
    No statistical analyses for this end point

    Secondary: Intraocular pressure analysis - Safety set

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    End point title
    		 Intraocular pressure analysis - Safety set
    End point description
    End point type
    Secondary
    End point timeframe
    at V1 and V4
    End point values
    		 Chloroprocaine Tetracaine
    Number of subjects analysed
    166
    172
    Units: mmHg
    arithmetic mean (standard deviation)
        IOP_V1_study eye
    15.10 ( 2.70 )
    15.02 ( 2.46 )
        IOP_V4_study eye
    14.73 ( 2.78 )
    14.85 ( 3.06 )
        IOP_V1_other eye
    14.90 ( 2.41 )
    14.88 ( 2.47 )
        IOP_V4_other eye
    14.80 ( 2.50 )
    14.95 ( 2.41 )
    No statistical analyses for this end point

    Secondary: Fundoscopy analysis - Safety set

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    End point title
    		 Fundoscopy analysis - Safety set
    End point description
    End point type
    Secondary
    End point timeframe
    at V1 and at V4
    End point values
    		 Chloroprocaine Tetracaine
    Number of subjects analysed
    166
    172
    Units: number of subjects
        Macula_V1_study eye_abnormal
    15
    16
        Macula_V1_study eye_normal
    149
    152
        Macula_V4_study eye_abnormal
    13
    10
        Macula_V4_study eye_normal
    152
    159
        Optic nerve_V1_study eye_abnormal
    16
    16
        Optic nerve_V1_study eye_normal
    149
    153
        Optic nerve_V4_study eye_abnormalv
    12
    10
        Optic nerve_V4_study eye_normal
    153
    159
        Retina_V1_study eye_abnormal
    13
    11
        Retina_V1_study eye_normal
    152
    158
        Retina_V4_study eye_abnormal
    13
    12
        Retina_V4_study eye_normal
    152
    157
        Macula_V1_other eye_abnormal
    14
    20
        Macula_V1_other eye_norma
    151
    152
        Macula_V4_other eye_abnorma
    10
    13
        Macula_V4_other eye_norma
    156
    155
        Optic nerve_V1_other eye_abnormal
    17
    16
        Optic nerve_V1_other eye_normal
    149
    156
        Optic nerve_V4_other eye_abnormal
    14
    10
        Optic nerve_V4_other eye_normal
    152
    158
        Retina_V1_other eye_abnormal
    12
    12
        Retina_V1_other eye_normal
    156
    160
        Retina_V4_other eye_abnormal
    14
    9
        Retina_V4_other eye_normal
    152
    159
    No statistical analyses for this end point

    Secondary: Specular microscopy analysis - Safety set

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    End point title
    		 Specular microscopy analysis - Safety set
    End point description
    Endothelial Cells Count [cell/mm2]
    End point type
    Secondary
    End point timeframe
    at V1 and at V4
    End point values
    		 Chloroprocaine Tetracaine
    Number of subjects analysed
    166 [4]
    172 [5]
    Units: cells/square millimiter
    arithmetic mean (standard deviation)
        Endothelial Cells Count_V1_study eye
    2440.76 ( 378.01 )
    2511.89 ( 325.32 )
        Endothelial Cells Count_V4_study eye
    2049.88 ( 620.43 )
    2166.96 ( 517.41 )
    Notes
    [4] - at V4, 161 subjects
    [5] - at V4, 165 subjects
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    from visit 2 to visit 5
    Adverse event reporting additional description
    All AEs derived by spontaneous, unsolicited reports of the patients, by observation and by routine open questioning were to be collected and reported.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Choloroprocaine 3% gel
    Reporting group description
    		 safety set

    Reporting group title
    Tetracaine 0.5% eye drop
    Reporting group description
    		 safety set

    Serious adverse events
    		 Choloroprocaine 3% gel Tetracaine 0.5% eye drop
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 166 (0.00%)
    0 / 172 (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
    		 Choloroprocaine 3% gel Tetracaine 0.5% eye drop
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 166 (8.43%)
    19 / 172 (11.05%)
    Investigations
    Blood pressure increased
         subjects affected / exposed
    0 / 166 (0.00%)
    3 / 172 (1.74%)
         occurrences all number
    0
    3
    intraoc
         subjects affected / exposed
    1 / 166 (0.60%)
    3 / 172 (1.74%)
         occurrences all number
    1
    6
    Injury, poisoning and procedural complications
    Incision site oedema
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 172 (0.00%)
         occurrences all number
    1
    0
    Procedural pain
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 172 (0.58%)
         occurrences all number
    0
    1
    Congenital, familial and genetic disorders
    Corneal dystrophy
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 172 (0.58%)
         occurrences all number
    0
    1
    Nervous system disorders
    Trigeminal neuralgia
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 172 (0.58%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 172 (0.00%)
         occurrences all number
    1
    0
    Sensation of foreign body
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 172 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Conjunctival haemorrhage
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 172 (0.00%)
         occurrences all number
    1
    0
    Conjunctivitis allergic
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 172 (0.58%)
         occurrences all number
    0
    1
    Corneal degeneration
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 172 (0.58%)
         occurrences all number
    0
    1
    Corneal disorder
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 172 (0.58%)
         occurrences all number
    0
    1
    Corneal oedema
         subjects affected / exposed
    5 / 166 (3.01%)
    2 / 172 (1.16%)
         occurrences all number
    5
    2
    Eye discharge
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 172 (0.58%)
         occurrences all number
    0
    1
    Hyperaesthesia eye
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 172 (0.00%)
         occurrences all number
    1
    0
    Iridocele
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 172 (0.58%)
         occurrences all number
    0
    1
    Lens dislocation
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 172 (0.58%)
         occurrences all number
    0
    1
    Ocular hypertension
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 172 (0.58%)
         occurrences all number
    0
    1
    Photophobia
         subjects affected / exposed
    1 / 166 (0.60%)
    1 / 172 (0.58%)
         occurrences all number
    1
    1
    Punctate keratitis
         subjects affected / exposed
    1 / 166 (0.60%)
    1 / 172 (0.58%)
         occurrences all number
    1
    1
    Pupillary deformity
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 172 (0.58%)
         occurrences all number
    0
    1
    Pupillary disorder
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 172 (0.58%)
         occurrences all number
    0
    1
    Retinal pigment epitheliopathy
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 172 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 172 (0.00%)
         occurrences all number
    1
    0
    Product issues
    Device dislocation
         subjects affected / exposed
    1 / 166 (0.60%)
    1 / 172 (0.58%)
         occurrences all number
    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
    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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