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    Clinical Trial Results:
    A phase II, multicenter, randomized, double-masked, 4 parallel arms, controlled 6-month trial designed to evaluate the safety and efficacy of PAD ciclosporin (CsA 0.06% and 0.03%) ophthalmic dispersion administered once daily in combination with lubricant therapy and a 3-month post-treatment safety follow-up in moderate to severe dry eye patients

    Summary
    EudraCT number
    		 2015-000937-54
    Trial protocol
    		 GB   DK   NO   AT   ES   PT   FR   SK   CZ  
    Global end of trial date
    30 Aug 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Mar 2020
    First version publication date
    11 Mar 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    MC2-03-C1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    MC2 Therapeutics Ltd
    Sponsor organisation address
    C/O Agern Alle 24-26, Hørsholm, Denmark, 2970
    Public contact
    Clinical Operations, MC2 Therapeutics Ltd, 45 25338893, mpr@mc2therapeutics.com
    Scientific contact
    Clinical Operations, MC2 Therapeutics Ltd, 45 25338893, mpr@mc2therapeutics.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
    30 Aug 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Aug 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Aug 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objectives of this study are to: 1. Evaluate the ocular tolerance and overall ocular safety of PADciclo (0.06% and 0.03%) in dry eye patients. 2. Evaluate the efficacy of PADciclo (0.06% and/or 0.03%) compared to current BSC administered once daily for 6 months in improving CFS in dry eye patients using a responder approach analysis.
    Protection of trial subjects
    The occurrence of AE is monitored throughout the study at all visits. During and following a patient's participation in the trial, the investigator is ensuring adequate medical care to patients for any adverse events, including clinically significant laboratory values, related to the trial. Supportive lubricant therapy was offered to all subjects throughout the trial.
    Background therapy
    		 The subjects are provided with Lubricant Therapy Supporting Medication (HydromoorTM, 0,3% hypromellose) for self-administration from the 2-week run-in period.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jun 2015
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 3 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Portugal: 17
    Country: Number of subjects enrolled
    Slovakia: 51
    Country: Number of subjects enrolled
    Spain: 99
    Country: Number of subjects enrolled
    United Kingdom: 4
    Country: Number of subjects enrolled
    Austria: 20
    Country: Number of subjects enrolled
    Czech Republic: 23
    Country: Number of subjects enrolled
    Denmark: 12
    Country: Number of subjects enrolled
    France: 29
    Country: Number of subjects enrolled
    Switzerland: 4
    Country: Number of subjects enrolled
    Norway: 4
    Worldwide total number of subjects
    263
    EEA total number of subjects
    259
    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)
    145
    From 65 to 84 years
    112
    85 years and over
    6

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Subject recruitment activities were based on database searches in local databases at the clinics and local advertisements.

    Pre-assignment
    Screening details
    		 After screening, the subjects entered the run-in period(s) of up to maximal 2 x 14 days before the treatment period. The purpose of this/these run-in period(s) was to determine the dose of supporting lubricant needed. The second run-in period was only relevant if it was not possible to decide on that optimal dose during the first run-in period.

    Pre-assignment period milestones
    Number of subjects started
    		 263
    Number of subjects completed
    		 263

    Period 1
    Period 1 title
    Treatment period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Monitor, Data analyst, Carer, Assessor, Subject
    Blinding implementation details
    All IMPs were supplied in identical appearing single-dose containers protected by paper/aluminium/polyethylene pouch packages. Each container, each pouch and each sealed cardboard box was carrying an investigational label, indicating that the content was intended for investigational use only. The labeling was complying with local regulatory requirements.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Safety PADciclo™ 0.06%
    Arm description
    		 The PADciclo™ ciclosporin 0.06% is a sterile ophthalmic dispersion filled in polyethylene, low density, single-dose container.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PADciclo™ 0.06% single-dose
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops, emulsion
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    During the 6-month treatment period patients will be instructed to instill one drop of study treatment once daily in each eye, at bedtime, at least one hour after the last daily instillation of the Supporting Medication. The first dose of IMP will be instilled after randomization, at bedtime of Day 0 (Baseline visit) at least one hour after the last daily instillation of the Supporting Medication. The treatment will continue up to 6 months. The last dose will be instilled at bedtime, at least one hour after the last daily instillation of the Supporting Medication, the day before Month 6 (End-of-Treatment Visit).

    Arm title
    		 Safety PADciclo™ 0.03%
    Arm description
    		 The PADciclo™ ciclosporin 0.03% is a sterile ophthalmic dispersion filled in polyethylene, low density, single-dose container.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PADciclo™ 0.03% single-dose
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops, emulsion
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    During the 6-month treatment period patients will be instructed to instill one drop of study treatment once daily in each eye, at bedtime, at least one hour after the last daily instillation of the Supporting Medication. The first dose of IMP will be instilled after randomization, at bedtime of Day 0 (Baseline visit) at least one hour after the last daily instillation of the Supporting Medication. The treatment will continue up to 6 months. The last dose will be instilled at bedtime, at least one hour after the last daily instillation of the Supporting Medication, the day before Month 6 (End-of-Treatment Visit).

    Arm title
    		 Safety PADciclo™ vehicle
    Arm description
    		 The PADciclo™ vehicle, where CsA is replaced by water, is a sterile ophthalmic dispersion filled in polyethylene, low density, single-dose container.
    Arm type
    		 Placebo

    Investigational medicinal product name
    PADciclo™ vehicle
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops, emulsion
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    During the 6-month treatment period patients will be instructed to instill one drop of study treatment once daily in each eye, at bedtime, at least one hour after the last daily instillation of the Supporting Medication. The first dose of IMP will be instilled after randomization, at bedtime of Day 0 (Baseline visit) at least one hour after the last daily instillation of the Supporting Medication. The treatment will continue up to 6 months. The last dose will be instilled at bedtime, at least one hour after the last daily instillation of the Supporting Medication, the day before Month 6 (End-of-Treatment Visit).

    Arm title
    		 Safety Best Standard Care (Lubricant therapy)
    Arm description
    		 The BSC (Lubricant therapy) is 0.3% hypromellose in polyethylene, low density, single-dose container.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Best Standard Care (Lubricant therapy)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops, solution
    Routes of administration
    Ocular use
    Dosage and administration details
    During the 6-month treatment period patients will be instructed to instill one drop of study treatment once daily in each eye, at bedtime, at least one hour after the last daily instillation of the Supporting Medication. The first dose of IMP will be instilled after randomization, at bedtime of Day 0 (Baseline visit) at least one hour after the last daily instillation of the Supporting Medication. The treatment will continue up to 6 months. The last dose will be instilled at bedtime, at least one hour after the last daily instillation of the Supporting Medication, the day before Month 6 (End-of-Treatment Visit).

    Number of subjects in period 1
    		Safety PADciclo™ 0.06% Safety PADciclo™ 0.03% Safety PADciclo™ vehicle Safety Best Standard Care (Lubricant therapy)
    Started
    70
    67
    63
    63
    Treatment period
    57
    61
    54
    56
    Completed
    57
    61
    54
    56
    Not completed
    13
    6
    9
    7
         Physician decision
    1
    -
    -
    -
         Consent withdrawn by subject
    2
    1
    5
    1
         Protocol specified withdrawal criterion met
    1
    -
    1
    -
         Adverse event, non-fatal
    9
    5
    2
    4
         Lost to follow-up
    -
    -
    -
    1
         Lack of efficacy
    -
    -
    1
    1
    Period 2
    Period 2 title
    Follow-up Safety Period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 PADciclo™ 0.06%
    Arm description
    		 During the 3 months follow-up Safety Period, only Supporting Medication lubricant therapy (Hydromoor™) were taken.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PADciclo™ 0.06% single-dose
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops, emulsion
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    During the 3 months follow-up Safety Period, only Supporting Medication lubricant therapy (Hydromoor™) were taken.

    Arm title
    		 PADciclo™ 0.03%
    Arm description
    		 During the 3 months follow-up Safety Period, only Supporting Medication lubricant therapy (Hydromoor™) were taken.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PADciclo™ 0.03% single-dose
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops, emulsion
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    During the 3 months follow-up Safety Period, only Supporting Medication lubricant therapy (Hydromoor™) were taken.

    Arm title
    		 PADciclo™ vehicle
    Arm description
    		 During the 3 months follow-up Safety Period, only Supporting Medication lubricant therapy (Hydromoor™) were taken.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PADciclo™ vehicle
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops, emulsion
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    During the 3 months follow-up Safety Period, only Supporting Medication lubricant therapy (Hydromoor™) were taken.

    Arm title
    		 Best Standard Care (Lubricant therapy)
    Arm description
    		 During the 3 months follow-up Safety Period, only Supporting Medication lubricant therapy (Hydromoor™) were taken.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Best Standard Care (Lubricant therapy)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops, solution
    Routes of administration
    Ocular use
    Dosage and administration details
    During the 3 months follow-up Safety Period, only Supporting Medication lubricant therapy (Hydromoor™) were taken.

    Number of subjects in period 2
    		PADciclo™ 0.06% PADciclo™ 0.03% PADciclo™ vehicle Best Standard Care (Lubricant therapy)
    Started
    57
    61
    54
    56
    Completed
    55
    60
    52
    54
    Not completed
    2
    1
    2
    2
         Consent withdrawn by subject
    -
    -
    -
    1
         Adverse event, non-fatal
    1
    1
    1
    -
         Unknown
    1
    -
    -
    -
         Lost to follow-up
    -
    -
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Safety PADciclo™ 0.06%
    Reporting group description
    		 The PADciclo™ ciclosporin 0.06% is a sterile ophthalmic dispersion filled in polyethylene, low density, single-dose container.

    Reporting group title
    Safety PADciclo™ 0.03%
    Reporting group description
    		 The PADciclo™ ciclosporin 0.03% is a sterile ophthalmic dispersion filled in polyethylene, low density, single-dose container.

    Reporting group title
    Safety PADciclo™ vehicle
    Reporting group description
    		 The PADciclo™ vehicle, where CsA is replaced by water, is a sterile ophthalmic dispersion filled in polyethylene, low density, single-dose container.

    Reporting group title
    Safety Best Standard Care (Lubricant therapy)
    Reporting group description
    		 The BSC (Lubricant therapy) is 0.3% hypromellose in polyethylene, low density, single-dose container.

    Reporting group values
    		 Safety PADciclo™ 0.06% Safety PADciclo™ 0.03% Safety PADciclo™ vehicle Safety Best Standard Care (Lubricant therapy) Total
    Number of subjects
    		 70 67 63 63 263
    Age categorical
    Units: Subjects
        Adult
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 59.99 ± 14.89 62.54 ± 11.84 61.89 ± 13.78 61.29 ± 14.09 -
    Gender categorical
    Units: Subjects
        Female
    		 63 64 55 58 240
        Male
    		 7 3 8 5 23

    End points

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    End points reporting groups
    Reporting group title
    Safety PADciclo™ 0.06%
    Reporting group description
    		 The PADciclo™ ciclosporin 0.06% is a sterile ophthalmic dispersion filled in polyethylene, low density, single-dose container.

    Reporting group title
    Safety PADciclo™ 0.03%
    Reporting group description
    		 The PADciclo™ ciclosporin 0.03% is a sterile ophthalmic dispersion filled in polyethylene, low density, single-dose container.

    Reporting group title
    Safety PADciclo™ vehicle
    Reporting group description
    		 The PADciclo™ vehicle, where CsA is replaced by water, is a sterile ophthalmic dispersion filled in polyethylene, low density, single-dose container.

    Reporting group title
    Safety Best Standard Care (Lubricant therapy)
    Reporting group description
    		 The BSC (Lubricant therapy) is 0.3% hypromellose in polyethylene, low density, single-dose container.
    Reporting group title
    PADciclo™ 0.06%
    Reporting group description
    		 During the 3 months follow-up Safety Period, only Supporting Medication lubricant therapy (Hydromoor™) were taken.

    Reporting group title
    PADciclo™ 0.03%
    Reporting group description
    		 During the 3 months follow-up Safety Period, only Supporting Medication lubricant therapy (Hydromoor™) were taken.

    Reporting group title
    PADciclo™ vehicle
    Reporting group description
    		 During the 3 months follow-up Safety Period, only Supporting Medication lubricant therapy (Hydromoor™) were taken.

    Reporting group title
    Best Standard Care (Lubricant therapy)
    Reporting group description
    		 During the 3 months follow-up Safety Period, only Supporting Medication lubricant therapy (Hydromoor™) were taken.

    Subject analysis set title
    FAS PADciclo™ 0.06%
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    FAS is defined as subjects having received at least one instillation and had at least one efficacy endpoint assessment done.

    Subject analysis set title
    FAS PADciclo™ 0.03%
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    FAS is defined as subjects having received at least one instillation and had at least one efficacy endpoint assessment done.

    Subject analysis set title
    FAS PADciclo™ vehicle
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    FAS is defined as subjects having received at least one instillation and had at least one efficacy endpoint assessment done.

    Subject analysis set title
    FAS Best Standard Care (Lubricant therapy)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    FAS is defined as subjects having received at least one instillation and had at least one efficacy endpoint assessment done.

    Primary: CFS response in the worse eye.

    		 Close Top of page
    End point title
    		 CFS response in the worse eye.
    End point description
    The primary endpoint was the efficacy of PADciclo™ 0.06% and 0.03% compared to current Best Standard Care and PADciclo™ vehicle, administered once daily for 6 months in improving CFS by at least 2 grades in dry eye patients using a responder approach analysis.
    End point type
    Primary
    End point timeframe
    After 6 months treatment
    End point values
    		 FAS PADciclo™ 0.06% FAS PADciclo™ 0.03% FAS PADciclo™ vehicle FAS Best Standard Care (Lubricant therapy)
    Number of subjects analysed
    68
    66
    58
    63
    Units: Percentage
    41
    46
    33
    33
    Statistical analysis title
    		 Corneal Fluorescein Staining response
    Statistical analysis description
    CFS (Corneal Fluorescein staining) response = improvement from Baseline to Month 6 in CFS of at least 2 grades, by using a Modified Oxford Scale (7-point ordinal scale, score 0, 0.5, 1, 2, 3, 4 and 5).
    Comparison groups
    FAS PADciclo™ 0.03% v FAS PADciclo™ vehicle v FAS Best Standard Care (Lubricant therapy) v FAS PADciclo™ 0.06%
    Number of subjects included in analysis
    255
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Fisher exact
    Parameter type
    		 Odds ratio (OR)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Event Reporting for each subject begin when a subject has signed the informed consent form and until the final Follow-Up Safety visit.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    PADciclo™ 0.06%
    Reporting group description
    		 The PADciclo™ is a sterile ophthalmic dispersion of CsA filled in polyethylene, low density, single-dose container. It possesses an intrinsic viscosity with a characteristic long residence time on the surface of the eye. During the 6-month treatment period patients was instructed to instill one drop of study treatment once daily in each eye, at bedtime.

    Reporting group title
    PADciclo™ 0.03%
    Reporting group description
    		 The PADciclo™ is a sterile ophthalmic dispersion of CsA filled in polyethylene, low density, single-dose container. It possesses an intrinsic viscosity with a characteristic long residence time on the surface of the eye. During the 6-month treatment period patients was instructed to instill one drop of study treatment once daily in each eye, at bedtime.

    Reporting group title
    PADciclo™ vehicle
    Reporting group description
    		 The PADciclo™ vehicle is identical to PADciclo™ 0.06% where CsA is replaced by water for injection and filled in polyethylene, low density, single-dose container. During the 6-month treatment period patients was instructed to instill one drop of study treatment once daily in each eye, at bedtime.

    Reporting group title
    Best Standard Care (Lubricant therapy)
    Reporting group description
    		 The BSC (Lubricant therapy) is 0.3% hypromellose in polyethylene, low density, single-dose container. During the 6-month treatment period patients was instructed to instill one drop of study treatment once daily in each eye, at bedtime.

    Serious adverse events
    		 PADciclo™ 0.06% PADciclo™ 0.03% PADciclo™ vehicle Best Standard Care (Lubricant therapy)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 70 (4.29%)
    2 / 67 (2.99%)
    4 / 63 (6.35%)
    2 / 63 (3.17%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    0 / 70 (0.00%)
    0 / 67 (0.00%)
    0 / 63 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myeloproliferative neoplasm
         subjects affected / exposed
    0 / 70 (0.00%)
    0 / 67 (0.00%)
    1 / 63 (1.59%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metastatic neoplasm
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 67 (1.49%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Mutiple injuries
         subjects affected / exposed
    0 / 70 (0.00%)
    0 / 67 (0.00%)
    1 / 63 (1.59%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiopulmonary failure
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 67 (0.00%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Sciatica
    Additional description: Right-side L4
         subjects affected / exposed
    0 / 70 (0.00%)
    0 / 67 (0.00%)
    0 / 63 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Retinal detachment
    Additional description: Left eye.
         subjects affected / exposed
    0 / 70 (0.00%)
    0 / 67 (0.00%)
    1 / 63 (1.59%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastro Intestinal pain
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 67 (0.00%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 67 (0.00%)
    1 / 63 (1.59%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Rib fracture
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 67 (0.00%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 67 (1.49%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cystitis
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 67 (0.00%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clostridium colitis
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 67 (0.00%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 70 (0.00%)
    0 / 67 (0.00%)
    1 / 63 (1.59%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 PADciclo™ 0.06% PADciclo™ 0.03% PADciclo™ vehicle Best Standard Care (Lubricant therapy)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    40 / 70 (57.14%)
    40 / 67 (59.70%)
    37 / 63 (58.73%)
    36 / 63 (57.14%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 70 (1.43%)
    4 / 67 (5.97%)
    2 / 63 (3.17%)
    0 / 63 (0.00%)
         occurrences all number
    1
    4
    2
    0
    General disorders and administration site conditions
    Instillation site pain
         subjects affected / exposed
    11 / 70 (15.71%)
    12 / 67 (17.91%)
    2 / 63 (3.17%)
    1 / 63 (1.59%)
         occurrences all number
    11
    12
    2
    1
    Eye disorders
    Blepharitis
         subjects affected / exposed
    5 / 70 (7.14%)
    5 / 67 (7.46%)
    3 / 63 (4.76%)
    3 / 63 (4.76%)
         occurrences all number
    5
    5
    3
    3
    Eye irritation
         subjects affected / exposed
    4 / 70 (5.71%)
    4 / 67 (5.97%)
    2 / 63 (3.17%)
    2 / 63 (3.17%)
         occurrences all number
    4
    4
    2
    2
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    2 / 70 (2.86%)
    1 / 67 (1.49%)
    4 / 63 (6.35%)
    0 / 63 (0.00%)
         occurrences all number
    2
    1
    4
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 70 (1.43%)
    3 / 67 (4.48%)
    5 / 63 (7.94%)
    6 / 63 (9.52%)
         occurrences all number
    1
    3
    5
    6

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Aug 2015
    Protocol version 3: Substantial amendment and corrections.
    08 Feb 2016
    Protocol version 6: Updates, protocol for France
    14 Jun 2016
    Protocol version 7: Substantial Amendment and Corrections.

    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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    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
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