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    Clinical Trial Results:
    Randomized, Double-Masked, Vehicle Controlled, Clinical Evaluation To Assess The Safety And Efficacy Of Nepafenac Ophthalmic Suspension, 0.3% For Improvement In Clinical Outcomes Among Diabetic Subjects Following Cataract Surgery

    Summary
    EudraCT number
    2013-001874-12
    Trial protocol
    HU   IT   DE   AT   ES  
    Global end of trial date
    28 May 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    09 Jun 2016
    First version publication date
    09 Jun 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    C-12-071
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01872611
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Alcon Research, Ltd.
    Sponsor organisation address
    6201 S. Freeway, Fort Worth, Texas, United States, 76134
    Public contact
    Head, Pharma, GCRA, Alcon Research, Ltd., +1 888-451-3937, alcon.medinfo@alcon.com
    Scientific contact
    Head, Pharma, GCRA, Alcon Research, Ltd., +1 888-451-3937, alcon.medinfo@alcon.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
    28 May 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 May 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    28 May 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate superiority of Nepafenac Ophthalmic Suspension, 0.3% dosed once daily relative to Nepafenac Vehicle based upon clinical outcomes among diabetic subjects following cataract surgery.
    Protection of trial subjects
    This study was performed in compliance with the ethical principles of the Declaration of Helsinki and Good Clinical Practice (GCP), including the archiving of essential documents.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    27 Nov 2013
    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: 64
    Country: Number of subjects enrolled
    Austria: 22
    Country: Number of subjects enrolled
    France: 1
    Country: Number of subjects enrolled
    Germany: 10
    Country: Number of subjects enrolled
    Hungary: 70
    Country: Number of subjects enrolled
    Italy: 8
    Country: Number of subjects enrolled
    Australia: 58
    Country: Number of subjects enrolled
    Colombia: 47
    Country: Number of subjects enrolled
    Israel: 67
    Country: Number of subjects enrolled
    Mexico: 93
    Country: Number of subjects enrolled
    Peru: 8
    Country: Number of subjects enrolled
    Philippines: 33
    Country: Number of subjects enrolled
    Singapore: 18
    Country: Number of subjects enrolled
    United States: 89
    Worldwide total number of subjects
    588
    EEA total number of subjects
    175
    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)
    185
    From 65 to 84 years
    394
    85 years and over
    9

    Subject disposition

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    Recruitment
    Recruitment details
    Subjects were recruited from 73 investigational centers located in the U.S., Europe, the Middle East, Africa, Latin America, the Caribbean, and the Asia Pacific region.

    Pre-assignment
    Screening details
    A total of 819 subjects were screened and 605 subjects were randomized to treatment; 17 of the randomized subjects did not receive treatment (one of which died prior to treatment).

    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
    Nepafenac
    Arm description
    With prednisolone acetate standard of care, Nepafenac Ophthalmic Suspension, 0.3%, 1 drop instilled in the operative eye 1 day prior to surgery, continuing on the day of surgery, and for 90 days following surgery. An additional 1 drop will be administered 30 to 120 minutes prior to surgery.
    Arm type
    Experimental

    Investigational medicinal product name
    Nepafenac Ophthalmic Suspension, 0.3%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops
    Routes of administration
    Ocular use
    Dosage and administration details
    1 drop instilled in the operative eye 1 day prior to surgery, continuing on the day of surgery, and for 90 days following surgery. An additional 1 drop will be administered 30 to 120 minutes prior to surgery.

    Investigational medicinal product name
    Prednisolone acetate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops, suspension
    Routes of administration
    Ocular use
    Dosage and administration details
    1 drop instilled in the operative eye 4 times daily beginning post-operatively on the day of surgery for the first 2 weeks, followed by 2 times daily for the next 2 weeks

    Arm title
    Vehicle
    Arm description
    With prednisolone acetate standard of care, Nepafenac vehicle, 1 drop instilled in the operative eye 1 day prior to surgery, continuing on the day of surgery, and for 90 days following surgery. An additional 1 drop will be administered 30 to 120 minutes prior to surgery.
    Arm type
    Placebo

    Investigational medicinal product name
    Vehicle
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops
    Routes of administration
    Ocular use
    Dosage and administration details
    1 drop instilled in the operative eye 1 day prior to surgery, continuing on the day of surgery, and for 90 days following surgery. An additional 1 drop will be administered 30 to 120 minutes prior to surgery.

    Investigational medicinal product name
    Prednisolone acetate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops, suspension
    Routes of administration
    Ocular use
    Dosage and administration details
    1 drop instilled in the operative eye 4 times daily beginning post-operatively on the day of surgery for the first 2 weeks, followed by 2 times daily for the next 2 weeks

    Number of subjects in period 1
    Nepafenac Vehicle
    Started
    293
    295
    Full Analysis Set
    289
    293
    Completed
    277
    292
    Not completed
    16
    3
         Adverse event, non-fatal
    3
    1
         Death
    -
    1
         Lost to follow-up
    8
    -
         Reason not specified
    -
    1
         Withdrawal by subject
    5
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Nepafenac
    Reporting group description
    With prednisolone acetate standard of care, Nepafenac Ophthalmic Suspension, 0.3%, 1 drop instilled in the operative eye 1 day prior to surgery, continuing on the day of surgery, and for 90 days following surgery. An additional 1 drop will be administered 30 to 120 minutes prior to surgery.

    Reporting group title
    Vehicle
    Reporting group description
    With prednisolone acetate standard of care, Nepafenac vehicle, 1 drop instilled in the operative eye 1 day prior to surgery, continuing on the day of surgery, and for 90 days following surgery. An additional 1 drop will be administered 30 to 120 minutes prior to surgery.

    Reporting group values
    Nepafenac Vehicle Total
    Number of subjects
    293 295 588
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    67.9 ± 8.6 68.1 ± 8.3 -
    Gender categorical
    Units: Subjects
        Female
    151 149 300
        Male
    142 146 288
    Subject analysis sets

    Subject analysis set title
    Nepafenac
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Full analysis set, defined as all randomized subjects who completed implant surgery and had at least one on-therapy postsurgical visit.

    Subject analysis set title
    Vehicle
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Full analysis set, defined as all randomized subjects who completed implant surgery and had at least one on-therapy postsurgical visit.

    Subject analysis sets values
    Nepafenac Vehicle
    Number of subjects
    289
    293
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    67.7 ± 8.5
    68.1 ± 8.4
    Gender categorical
    Units: Subjects
        Female
    149
    149
        Male
    140
    144

    End points

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    End points reporting groups
    Reporting group title
    Nepafenac
    Reporting group description
    With prednisolone acetate standard of care, Nepafenac Ophthalmic Suspension, 0.3%, 1 drop instilled in the operative eye 1 day prior to surgery, continuing on the day of surgery, and for 90 days following surgery. An additional 1 drop will be administered 30 to 120 minutes prior to surgery.

    Reporting group title
    Vehicle
    Reporting group description
    With prednisolone acetate standard of care, Nepafenac vehicle, 1 drop instilled in the operative eye 1 day prior to surgery, continuing on the day of surgery, and for 90 days following surgery. An additional 1 drop will be administered 30 to 120 minutes prior to surgery.

    Subject analysis set title
    Nepafenac
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Full analysis set, defined as all randomized subjects who completed implant surgery and had at least one on-therapy postsurgical visit.

    Subject analysis set title
    Vehicle
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Full analysis set, defined as all randomized subjects who completed implant surgery and had at least one on-therapy postsurgical visit.

    Primary: Percentage of Participants With Best-corrected Visual Acuity (BCVA) Improvement of ≥ 15 Letters From Preoperative Baseline to Day 14 and Maintained Through Day 90

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    End point title
    Percentage of Participants With Best-corrected Visual Acuity (BCVA) Improvement of ≥ 15 Letters From Preoperative Baseline to Day 14 and Maintained Through Day 90
    End point description
    BCVA (with spectacles or other visual corrective devices) was reported in letters read correctly, using the Early Treatment Diabetic Retinopathy Study (ETDRS) test of 70 letters. Improvement of BCVA was defined as an increase (gain) in the number of letters read, compared to the baseline assessment. One eye (study eye) contributed to the analysis.
    End point type
    Primary
    End point timeframe
    Baseline to Day 14, and maintained through Day 90
    End point values
    Nepafenac Vehicle
    Number of subjects analysed
    289
    293
    Units: Percentage of participants
        number (not applicable)
    48.8
    50.5
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    Parameter dispersion is the standard error for the odds ratio.
    Comparison groups
    Nepafenac v Vehicle
    Number of subjects included in analysis
    582
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.671
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    0.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.7
         upper limit
    1.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.2

    Primary: Measure Title Percentage of Participants Who Develop Macular Edema Within 90 Days Following Cataract Surgery (Day 0)

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    End point title
    Measure Title Percentage of Participants Who Develop Macular Edema Within 90 Days Following Cataract Surgery (Day 0)
    End point description
    Macular edema was defined as ≥ 30% Increase from pre-operative baseline in central subfield macular thickness, as measured with Spectral Domain Ocular Coherence Tomography (SD-OCT). One eye (study eye) contributed to the analysis.
    End point type
    Primary
    End point timeframe
    Day 0 to Day 90
    End point values
    Nepafenac Vehicle
    Number of subjects analysed
    289
    293
    Units: Percentage of participants
        number (not applicable)
    5.9
    14.3
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    Parameter dispersion is the standard error for the odds ratio.
    Comparison groups
    Nepafenac v Vehicle
    Number of subjects included in analysis
    582
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.001
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    0.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.2
         upper limit
    0.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.1

    Secondary: Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 90

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    End point title
    Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 90
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Day 90
    End point values
    Nepafenac Vehicle
    Number of subjects analysed
    289
    293
    Units: Percentage of participants
        number (not applicable)
    65.4
    65.9
    No statistical analyses for this end point

    Secondary: Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 60

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    End point title
    Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 60
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Day 60
    End point values
    Nepafenac Vehicle
    Number of subjects analysed
    289
    293
    Units: Percentage of participants
        number (not applicable)
    68.9
    62.1
    No statistical analyses for this end point

    Secondary: Percentage of Participants With a > 5-letter Loss in BCVA From Day 7 to Any Visit

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    End point title
    Percentage of Participants With a > 5-letter Loss in BCVA From Day 7 to Any Visit
    End point description
    End point type
    Secondary
    End point timeframe
    Day 7 up to any visit
    End point values
    Nepafenac Vehicle
    Number of subjects analysed
    289
    293
    Units: Percentage of participants
        number (not applicable)
    18.7
    16.7
    No statistical analyses for this end point

    Secondary: Percentage of Participants With With a > 10-letter Loss in BCVA From Day 7 to Any Visit

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    End point title
    Percentage of Participants With With a > 10-letter Loss in BCVA From Day 7 to Any Visit
    End point description
    End point type
    Secondary
    End point timeframe
    Day 7 up to any visit
    End point values
    Nepafenac Vehicle
    Number of subjects analysed
    289
    293
    Units: Percentage of participants
        number (not applicable)
    10.7
    8.9
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if applicable). Ocular adverse events are presented for both study eye and nonstudy eye combined.
    Adverse event reporting additional description
    An AE was defined as any untoward medical occurrence in a subject after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the subject.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Nepafenac
    Reporting group description
    Nepafenac Ophthalmic Suspension, 0.3%

    Reporting group title
    Vehicle
    Reporting group description
    Nepafenac Ophthalmic Suspension Vehicle

    Reporting group title
    Posttreatment
    Reporting group description
    All subjects after cessation of study treatment up to study exit

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: There are no non-serious events at the 5% threshold.
    Serious adverse events
    Nepafenac Vehicle Posttreatment
    Total subjects affected by serious adverse events
         subjects affected / exposed
    14 / 293 (4.78%)
    14 / 295 (4.75%)
    4 / 588 (0.68%)
         number of deaths (all causes)
    0
    1
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 293 (0.00%)
    1 / 295 (0.34%)
    0 / 588 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    1 / 293 (0.34%)
    0 / 295 (0.00%)
    0 / 588 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral artery stenosis
         subjects affected / exposed
    1 / 293 (0.34%)
    0 / 295 (0.00%)
    0 / 588 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thrombosis
         subjects affected / exposed
    1 / 293 (0.34%)
    0 / 295 (0.00%)
    0 / 588 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Arteriovenous fistula operation
         subjects affected / exposed
    0 / 293 (0.00%)
    1 / 295 (0.34%)
    0 / 588 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intra-ocular injection
         subjects affected / exposed
    0 / 293 (0.00%)
    1 / 295 (0.34%)
    0 / 588 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin graft
         subjects affected / exposed
    1 / 293 (0.34%)
    0 / 295 (0.00%)
    0 / 588 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 293 (0.00%)
    1 / 295 (0.34%)
    0 / 588 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Device dislocation
         subjects affected / exposed
    1 / 293 (0.34%)
    0 / 295 (0.00%)
    0 / 588 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic shock
         subjects affected / exposed
    0 / 293 (0.00%)
    1 / 295 (0.34%)
    0 / 588 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    1 / 293 (0.34%)
    0 / 295 (0.00%)
    0 / 588 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 293 (0.34%)
    0 / 295 (0.00%)
    0 / 588 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Femur fracture
         subjects affected / exposed
    0 / 293 (0.00%)
    1 / 295 (0.34%)
    0 / 588 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    1 / 293 (0.34%)
    0 / 295 (0.00%)
    0 / 588 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    0 / 293 (0.00%)
    1 / 295 (0.34%)
    0 / 588 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    0 / 293 (0.00%)
    1 / 295 (0.34%)
    0 / 588 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrial flutter
         subjects affected / exposed
    0 / 293 (0.00%)
    1 / 295 (0.34%)
    0 / 588 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    0 / 293 (0.00%)
    1 / 295 (0.34%)
    0 / 588 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    0 / 293 (0.00%)
    1 / 295 (0.34%)
    0 / 588 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Coronary artery occlusion
         subjects affected / exposed
    1 / 293 (0.34%)
    0 / 295 (0.00%)
    0 / 588 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    2 / 293 (0.68%)
    1 / 295 (0.34%)
    0 / 588 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatic encephalopathy
         subjects affected / exposed
    0 / 293 (0.00%)
    1 / 295 (0.34%)
    0 / 588 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 293 (0.00%)
    0 / 295 (0.00%)
    1 / 588 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Diabetic retinal oedema
         subjects affected / exposed
    0 / 293 (0.00%)
    0 / 295 (0.00%)
    1 / 588 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Optic ischaemic neuropathy
         subjects affected / exposed
    0 / 293 (0.00%)
    0 / 295 (0.00%)
    1 / 588 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Posterior capsule rupture
         subjects affected / exposed
    1 / 293 (0.34%)
    0 / 295 (0.00%)
    0 / 588 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Rectal haemorrhage
         subjects affected / exposed
    0 / 293 (0.00%)
    1 / 295 (0.34%)
    0 / 588 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 293 (0.34%)
    0 / 295 (0.00%)
    0 / 588 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc degeneration
         subjects affected / exposed
    1 / 293 (0.34%)
    0 / 295 (0.00%)
    0 / 588 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vertebral foraminal stenosis
         subjects affected / exposed
    1 / 293 (0.34%)
    0 / 295 (0.00%)
    0 / 588 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 293 (0.34%)
    0 / 295 (0.00%)
    0 / 588 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 293 (0.34%)
    0 / 295 (0.00%)
    0 / 588 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    1 / 293 (0.34%)
    0 / 295 (0.00%)
    0 / 588 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    0 / 293 (0.00%)
    1 / 295 (0.34%)
    0 / 588 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 293 (0.00%)
    2 / 295 (0.68%)
    0 / 588 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    0 / 293 (0.00%)
    0 / 295 (0.00%)
    1 / 588 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Nepafenac Vehicle Posttreatment
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 293 (0.00%)
    0 / 295 (0.00%)
    0 / 588 (0.00%)

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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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