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    Clinical Trial Results:
    A Randomized, Multicenter, Double-Masked, Parallel-Group Clinical Safety and Efficacy Evaluation of Loteprednol Etabonate Ophthalmic Gel, 0.5% Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery

    Summary
    EudraCT number
    		 2010-019246-11
    Trial protocol
    		 GB  
    Global end of trial date
    03 Sep 2010

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Jan 2020
    First version publication date
    02 Jan 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    577
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01060072
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bausch & Lomb Incorporated
    Sponsor organisation address
    1400 North Goodman St., Rochester, NY, United States, 14609
    Public contact
    Director of Clinical Operations, Bausch & Lomb Incorporated, 011 9733606389, tuyen.ong@bausch.com
    Scientific contact
    Director of Clinical Operations, Bausch & Lomb Incorporated, 011 9733606389, tuyen.ong@bausch.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
    03 Sep 2010
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Sep 2010
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Sep 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objectives of this study were to compare the safety and efficacy of loteprednol etabonate ophthalmic gel, 0.5% to vehicle for the treatment of inflammation and pain following cataract surgery.
    Protection of trial subjects
    This study was conducted in compliance with the protocol and in accordance with Good Clinical Practice (GCP), as described in the International Conference on Harmonisation (ICH) Harmonized Tripartite Guidelines for Good Clinical Practice 1996 Food and Drug Administration (FDA) regulations 21CFR Parts 50, 54, 56, and 312, 42 USC 282(j), applicable local regulations, and the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Feb 2010
    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
    United States: 391
    Country: Number of subjects enrolled
    Germany: 16
    Worldwide total number of subjects
    407
    EEA total number of subjects
    16
    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)
    122
    From 65 to 84 years
    272
    85 years and over
    13

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted at 22 enrolling sites; 2 in the European Union (EU) and 20 in the United States (US). First participant was enrolled on 2/19/2010 and last participant completed the study on 9/3/2010.

    Pre-assignment
    Screening details
    		 A total of 407 participants, who were candidates for routine, uncomplicated cataract surgery, were enrolled in the study, 400 participants completed the study.

    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
    Are arms mutually exclusive
    Yes

    Arm title
    		 Loteprednol etabonate
    Arm description
    		 Loteprednol etabonate 0.5% ophthalmic suspension
    Arm type
    		 Experimental

    Investigational medicinal product name
    Loteprednol etabonate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops, suspension
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    Topical administration of loteprednol etabonate ophthalmic suspension 1-2 drops in study eye four times a day (QID), postoperative day 1-14.

    Arm title
    		 Vehicle
    Arm description
    		 Vehicle of loteprednol etabonate ophthalmic suspension.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Vehicle of Loteprednol Etabonate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops, suspension
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    Topical administration of vehicle of loteprednol etabonate ophthalmic suspension 1-2 drops in study eye QID, postoperative day 1-14.

    Number of subjects in period 1
    		Loteprednol etabonate Vehicle
    Started
    206
    201
    Completed
    204
    196
    Not completed
    2
    5
         Physician decision
    -
    2
         Acute cholecystitis
    1
    -
         Adverse event, non-fatal
    1
    1
         Excluded Medications
    -
    1
         Protocol deviation
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Loteprednol etabonate
    Reporting group description
    		 Loteprednol etabonate 0.5% ophthalmic suspension

    Reporting group title
    Vehicle
    Reporting group description
    		 Vehicle of loteprednol etabonate ophthalmic suspension.

    Reporting group values
    		 Loteprednol etabonate Vehicle Total
    Number of subjects
    		 206 201 407
    Age categorical
    Units: Subjects
    Age Continuous
    Intent to treat Population (ITT)
    Units: years
        arithmetic mean (standard deviation)
    		 68.3 ± 9.66 69.4 ± 9.56 -
    Gender, Male/Female
    Units: Subjects
        Female
    		 124 109 233
        Male
    		 82 92 174
    Region of Enrollment
    Units: Subjects
        United States
    		 198 193 391
        Germany
    		 8 8 16

    End points

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    End points reporting groups
    Reporting group title
    Loteprednol etabonate
    Reporting group description
    		 Loteprednol etabonate 0.5% ophthalmic suspension

    Reporting group title
    Vehicle
    Reporting group description
    		 Vehicle of loteprednol etabonate ophthalmic suspension.

    Primary: Resolution of anterior chamber cells at Visit 5

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    End point title
    		 Resolution of anterior chamber cells at Visit 5
    End point description
    Participants with complete resolution of anterior chamber cells (ACC). ITT population.
    End point type
    Primary
    End point timeframe
    Visit 5 (Postoperative Day 8)
    End point values
    		 Loteprednol etabonate Vehicle
    Number of subjects analysed
    206
    201
    Units: participants
    64
    28
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Loteprednol etabonate v Vehicle
    Number of subjects included in analysis
    407
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [1]
    Method
    		 Chi-squared
    Confidence interval
    Notes
    [1] - p-value obtained from Pearson chi-squared statistic. Pearson value was the primary outcome and Grade 0 (no) pain was only tested if complete resolution of cells was significant at the 0.05 level.

    Primary: Grade 0 pain at Visit 5

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    End point title
    		 Grade 0 pain at Visit 5
    End point description
    Participants with no pain, graded on a 0-5 scale, 0=no pain and 5=severe pain. ITT population.
    End point type
    Primary
    End point timeframe
    Visit 5 (Postoperative Day 8)
    End point values
    		 Loteprednol etabonate Vehicle
    Number of subjects analysed
    206
    201
    Units: participants
    206
    201
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Difference in percentages and 95% CI were based on asymptotic normal approximations.
    Comparison groups
    Loteprednol etabonate v Vehicle
    Number of subjects included in analysis
    407
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [2]
    Method
    		 Chi-squared
    Parameter type
    		 Difference in percentage
    Point estimate
    30
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 20.4
         upper limit
    		 39.5
    Notes
    [2] - p-value obtained from Pearson chi-squared statistic. Pearson value was the primary outcome and Grade 0 (no) pain was only tested if complete resolution of cells was significant at the 0.05 level.

    Secondary: Resolution of anterior chamber cells at Visit 4-7

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    End point title
    		 Resolution of anterior chamber cells at Visit 4-7
    End point description
    Participants with complete resolution of anterior chamber cells (ACC). Cells were graded on a 0-4 scale, where 0=no cells and 4=>30 cells. ITT population.
    End point type
    Secondary
    End point timeframe
    Visit 4-7 (postoperative Day 3-18)
    End point values
    		 Loteprednol etabonate Vehicle
    Number of subjects analysed
    206
    201
    Units: participants
        Visit 4 (Postoperative Day 3)
    8
    7
        Visit 5 (Postoperative Day 8)
    64
    28
        Visit 6 (Postoperative Day 15)
    116
    61
        Visit 7 (Postoperative Day 18)
    114
    59
    No statistical analyses for this end point

    Secondary: Grade 0 pain at Visit 4-7

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    End point title
    		 Grade 0 pain at Visit 4-7
    End point description
    Participants with no pain, graded on a 0-5 scale, 0= no pain and 5=severe pain. ITT population.
    End point type
    Secondary
    End point timeframe
    Visits 4-7 (Postoperative Days 3-18)
    End point values
    		 Loteprednol etabonate Vehicle
    Number of subjects analysed
    206
    201
    Units: participants
        Visit 4 (Postoperative Day 3)
    139
    93
        Visit 5 (Postoperative Day 8)
    156
    92
        Visit 6 (Postoperative Day 15)
    160
    89
        Visit 7 (Postoperative Day 18)
    151
    79
    No statistical analyses for this end point

    Secondary: Resolution of anterior chamber flare

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    End point title
    		 Resolution of anterior chamber flare
    End point description
    Complete resolution of flare, scored on a scale of 0-4 were 0=none and 4=very severe. ITT population.
    End point type
    Secondary
    End point timeframe
    Visit 4-7 (postoperative Day 3-18)
    End point values
    		 Loteprednol etabonate Vehicle
    Number of subjects analysed
    206
    201
    Units: participants
        Visit 4 (Postoperative Day 3)
    93
    64
        Visit 5 (Postoperative Day 8)
    134
    72
        Visit 6 (Postoperative Day 15)
    162
    90
        Visit 7 (Postoperative Day 18)
    143
    75
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    14 Days
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.0
    Reporting groups
    Reporting group title
    Vehicle
    Reporting group description
    		 Vehicle of loteprednol etabonate ophthalmic suspension.

    Reporting group title
    Loteprednol etabonate
    Reporting group description
    		 Loteprednol etabonate 0.5% ophthalmic suspension

    Serious adverse events
    		 Vehicle Loteprednol etabonate
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 201 (0.50%)
    3 / 206 (1.46%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Cardiac disorders
    Myocardial infarction
         subjects affected / exposed
    0 / 201 (0.00%)
    1 / 206 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diverticulitis
         subjects affected / exposed
    0 / 201 (0.00%)
    1 / 206 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    0 / 201 (0.00%)
    1 / 206 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 201 (0.50%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalemia
         subjects affected / exposed
    1 / 201 (0.50%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Vehicle Loteprednol etabonate
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    24 / 201 (11.94%)
    10 / 206 (4.85%)
    Eye disorders
    Anterior Chamber Inflammation
         subjects affected / exposed
    14 / 201 (6.97%)
    7 / 206 (3.40%)
         occurrences all number
    14
    7
    Eye Pain
         subjects affected / exposed
    10 / 201 (4.98%)
    3 / 206 (1.46%)
         occurrences all number
    10
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Mar 2010
    Key changes for the amendment were related to the addition of 4 investigative sites in the European Union. The approximate number of participants to be enrolled by each investigator was changed from 20 to 17 participants. All other changes involved specification of personnel, definitions of terms, product labeling, sites for the return of unused product, etc.

    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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