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    Clinical Trial Results:
    Phase III, Multinational, Multicenter, Investigator-Masked, Randomised, Active-Controlled Trial, comparing the efficacy and safety of DE-130A with Xalatan® in Patients with Open-Angle Glaucoma or Ocular Hypertension over a 3-Month period, followed by a 12-Month Follow-Up with Open-Label DE-130A Treatment

    Summary
    EudraCT number
    		 2017-004262-95
    Trial protocol
    		 FI   GB   DE   EE   PL   ES   BE   AT   LV   IT  
    Global end of trial date
    26 Oct 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Nov 2023
    First version publication date
    12 Nov 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    0130A01SA
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04133311
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Santen S.A.S.
    Sponsor organisation address
    1 Rue Pierre Fontaine, Genavenir IV, Evry cedex, France, F-91058
    Public contact
    Regulatory Affairs EMEA, Santen S.A.S., regulatoryaffairs@santen.com
    Scientific contact
    Regulatory Affairs EMEA, Santen S.A.S., regulatoryaffairs@santen.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
    10 Nov 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Feb 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Oct 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate that the intraocular pressure (IOP) reducing effect of DE-130A (latanoprost 50 µg/ml preservative-free eye drops emulsion) is non-inferior to that of Xalatan® [latanoprost 50 µg/ml Benzalkonium Chloride (BAK)-preserved eye drops solution] in patients with Open-Angle Glaucoma (OAG) or Ocular Hypertension (OHT) at Week 12 without using any rescue medication(s).
    Protection of trial subjects
    This study was conducted in accordance with International Council for Harmonisation (ICH) of Good Clinical Practice (GCP), ethical principles that have their origin in the Declaration of Helsinki as well as other applicable ethical and regulatory requirements. The final protocol, its amendments, and Informed Consent Form (ICF), relevant supporting information, and patient recruitment information were submitted by the Investigator to an Independent Ethics Committee (IEC) and/or Institutional Review Board (IRB) and approved by the IEC/IRB prior to study initiation.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 Apr 2019
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 12 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 9
    Country: Number of subjects enrolled
    Spain: 43
    Country: Number of subjects enrolled
    United Kingdom: 13
    Country: Number of subjects enrolled
    Austria: 7
    Country: Number of subjects enrolled
    Belgium: 11
    Country: Number of subjects enrolled
    Estonia: 29
    Country: Number of subjects enrolled
    Finland: 5
    Country: Number of subjects enrolled
    France: 4
    Country: Number of subjects enrolled
    Germany: 15
    Country: Number of subjects enrolled
    Italy: 37
    Country: Number of subjects enrolled
    Latvia: 26
    Country: Number of subjects enrolled
    Russian Federation: 181
    Country: Number of subjects enrolled
    Korea, Republic of: 6
    Worldwide total number of subjects
    386
    EEA total number of subjects
    186
    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)
    198
    From 65 to 84 years
    186
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Out of 488 patients screened, 386 were randomised at Visit 1, n=193 to the DE-130A group and n=193 to the control (Xalatan®) group. Out of 137 patients who participated in Period 2, 71 had previously been treated with DE-130A and 66 with Xalatan® during Period 1. All 137 subjects were administered at least one dose of DE-130A.

    Period 1
    Period 1 title
    Double Masked Treatment Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind [1]
    Roles blinded
    		 Investigator, Monitor, Data analyst
    Blinding implementation details
    Instillation of one drop, once daily in the evening (9 pm ±1 hour) in the conjunctival sac of the affected eye(s). Both eyes will be treated unless the patient suffers from unilateral OAG/OHT. DE-130A: Latanoprost 50 microg/ml eye drops emulsion, eye drops emulsion in single-dose containers

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Period 1: DE-130A
    Arm description
    		 DE-130A: Latanoprost 50 microg/ml preservative-free eye drops emulsion, eye drops emulsion in single-dose containers. Instillation of one drop, once daily in the evening (9 pm ±1 hour) in the conjunctival sac of the affected eye(s). Both eyes will be treated unless the patient suffers from unilateral OAG/OHT.
    Arm type
    		 Experimental

    Investigational medicinal product name
    DE-130A
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops, emulsion
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    Instillation of one drop, once daily in the evening (9 pm ±1 hour) in the conjunctival sac of the affected eye(s).

    Arm title
    		 Period 1: Xalatan
    Arm description
    		 Xalatan: Latanoprost 50 microg/ml eye drops solution, eye drops in 2.5 ml dropper containers. Instillation of one drop, once daily in the evening (9 pm ± 1 hour) in the conjunctival sac of the affected eye(s).Both eyes will be treated unless the patient suffers from unilateral OAG/OH.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Xalatan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops, solution
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    Instillation of one drop, once daily in the evening (9 pm ±1 hour) in the conjunctival sac of the affected eye(s).

    Notes
    [1] - The roles blinded appear to be inconsistent with a double blind trial.
    Justification: The patients did not be explicitly told about the name of the study drug by the drug dispensing staff.
    Number of subjects in period 1
    		Period 1: DE-130A Period 1: Xalatan
    Started
    193
    193
    Completed
    190
    190
    Not completed
    3
    3
         Adverse event, serious fatal
    1
    -
         Consent withdrawn by subject
    1
    1
         Adverse event, non-fatal
    1
    1
         Sponsor Temporarily Discontinued Study
    -
    1
    Period 2
    Period 2 title
    Open Label Treatment Period
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Period 2: DE-130A/DE-130A
    Arm description
    		 DE-130A: Latanoprost 50 microg/ml preservative-free eye drops emulsion, eye drops emulsion in single-dose containers. After 12 weeks, participants continued to use DE-130A for additional 12 months. Instillation of one drop, once daily in the evening (9 pm ±1 hour) in the conjunctival sac of the affected eye(s). Both eyes will be treated unless the patient suffers from unilateral OAG/OHT.
    Arm type
    		 Open-label

    Investigational medicinal product name
    DE-130A
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops, emulsion
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    Instillation of one drop, once daily in the evening (9 pm ±1 hour) in the conjunctival sac of the affected eye(s).

    Arm title
    		 Period 2: Xalatan/DE-130A
    Arm description
    		 DE-130A: Latanoprost 50 microg/ml preservative-free eye drops emulsion, eye drops emulsion in single-dose containers. After 12 weeks, participants were converted to use DE-130A instead of Xalatan®. Instillation of one drop, once daily in the evening (9 pm ±1 hour) in the conjunctival sac of the affected eye(s). Both eyes will be treated unless the patient suffers from unilateral OAG/OHT.
    Arm type
    		 Open-label

    Investigational medicinal product name
    DE-130A
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops, emulsion
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    Instillation of one drop, once daily in the evening (9 pm ±1 hour) in the conjunctival sac of the affected eye(s).

    Number of subjects in period 2 [2]
    		Period 2: DE-130A/DE-130A Period 2: Xalatan/DE-130A
    Started
    71
    66
    Completed
    67
    62
    Not completed
    4
    4
         Consent withdrawn by subject
    2
    2
         Early Terminated
    1
    -
         Adverse event, non-fatal
    -
    2
         Pregnancy
    1
    -
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: It was defined in protocol as follows, and the number of subjects is as planned.The first 130 patients who completed the week 12 visit and agreed to participate in the open-label period of the study were followed for 12 months from week 12 and received open-label DE-130A treatment.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Period 1: DE-130A
    Reporting group description
    		 DE-130A: Latanoprost 50 microg/ml preservative-free eye drops emulsion, eye drops emulsion in single-dose containers. Instillation of one drop, once daily in the evening (9 pm ±1 hour) in the conjunctival sac of the affected eye(s). Both eyes will be treated unless the patient suffers from unilateral OAG/OHT.

    Reporting group title
    Period 1: Xalatan
    Reporting group description
    		 Xalatan: Latanoprost 50 microg/ml eye drops solution, eye drops in 2.5 ml dropper containers. Instillation of one drop, once daily in the evening (9 pm ± 1 hour) in the conjunctival sac of the affected eye(s).Both eyes will be treated unless the patient suffers from unilateral OAG/OH.

    Reporting group values
    		 Period 1: DE-130A Period 1: Xalatan Total
    Number of subjects
    		 193 193 386
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 103 95 198
        From 65-84 years
    		 88 98 186
        85 years and over
    		 2 0 2
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 62.3 ( 12.04 ) 63.9 ( 10.13 ) -
    Gender categorical
    Units: Subjects
        Female
    		 121 117 238
        Male
    		 72 76 148

    End points

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    End points reporting groups
    Reporting group title
    Period 1: DE-130A
    Reporting group description
    		 DE-130A: Latanoprost 50 microg/ml preservative-free eye drops emulsion, eye drops emulsion in single-dose containers. Instillation of one drop, once daily in the evening (9 pm ±1 hour) in the conjunctival sac of the affected eye(s). Both eyes will be treated unless the patient suffers from unilateral OAG/OHT.

    Reporting group title
    Period 1: Xalatan
    Reporting group description
    		 Xalatan: Latanoprost 50 microg/ml eye drops solution, eye drops in 2.5 ml dropper containers. Instillation of one drop, once daily in the evening (9 pm ± 1 hour) in the conjunctival sac of the affected eye(s).Both eyes will be treated unless the patient suffers from unilateral OAG/OH.
    Reporting group title
    Period 2: DE-130A/DE-130A
    Reporting group description
    		 DE-130A: Latanoprost 50 microg/ml preservative-free eye drops emulsion, eye drops emulsion in single-dose containers. After 12 weeks, participants continued to use DE-130A for additional 12 months. Instillation of one drop, once daily in the evening (9 pm ±1 hour) in the conjunctival sac of the affected eye(s). Both eyes will be treated unless the patient suffers from unilateral OAG/OHT.

    Reporting group title
    Period 2: Xalatan/DE-130A
    Reporting group description
    		 DE-130A: Latanoprost 50 microg/ml preservative-free eye drops emulsion, eye drops emulsion in single-dose containers. After 12 weeks, participants were converted to use DE-130A instead of Xalatan®. Instillation of one drop, once daily in the evening (9 pm ±1 hour) in the conjunctival sac of the affected eye(s). Both eyes will be treated unless the patient suffers from unilateral OAG/OHT.

    Primary: Intraocular Pressure (IOP) Reduction (mmHg) at Week 12

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    End point title
    		 Intraocular Pressure (IOP) Reduction (mmHg) at Week 12
    End point description
    The primary efficacy endpoint was the change from baseline in peak (9:00 am ± 1 hour) and trough (4:00 pm ± 1 hour) IOPs, respectively, at Week 12 between the two treatment groups in the study eye.
    End point type
    Primary
    End point timeframe
    Week 12: Peak (9:00 am ± 1 hour) and trough (4:00 pm ± 1 hour)
    End point values
    		 Period 1: DE-130A Period 1: Xalatan
    Number of subjects analysed
    188
    189
    Units: mmHg
    least squares mean (standard error)
        peak (9:00 am ± 1 hour)
    -8.8 ( 0.25 )
    -8.2 ( 0.26 )
    Statistical analysis title
    		 PRIMARY EFFICACY ENDPOINT
    Statistical analysis description
    The primary efficacy endpoint was change from baseline in peak and trough IOP at Week 12 in the study eye. Non-inferiority was established if the upper limit of the one-sided 97.5% CI is ≤ 1.5 mmHg at both the peak and trough timepoints.
    Comparison groups
    Period 1: DE-130A v Period 1: Xalatan
    Number of subjects included in analysis
    377
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0
    Confidence interval
         level
    		 97.5%
         sides
    1-sided
         lower limit
    		 -
         upper limit
    		 1.5
    Variability estimate
    Standard deviation
    Dispersion value
    4.26

    Primary: Intraocular Pressure (IOP) Reduction (mmHg) at Week 12

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    End point title
    		 Intraocular Pressure (IOP) Reduction (mmHg) at Week 12
    End point description
    The primary efficacy endpoint was the change from baseline in peak (9:00 am ± 1 hour) and trough (4:00 pm ± 1 hour) IOPs, respectively, at Week 12 between the two treatment groups in the study eye.
    End point type
    Primary
    End point timeframe
    Week 12 (16:00) trough timepoint
    End point values
    		 Period 1: DE-130A Period 1: Xalatan
    Number of subjects analysed
    186
    188
    Units: mmHg
    least squares mean (standard error)
        (16:00) trough timepoint
    -8.6 ( 0.24 )
    -8.1 ( 0.25 )
    Statistical analysis title
    		 PRIMARY EFFICACY ENDPOINT
    Statistical analysis description
    The primary efficacy endpoint was change from baseline in peak and trough IOP at Week 12 in the study eye. Non-inferiority was established if the upper limit of the one-sided 97.5% CI is ≤ 1.5 mmHg at both the peak and trough timepoints.
    Comparison groups
    Period 1: DE-130A v Period 1: Xalatan
    Number of subjects included in analysis
    374
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0
    Confidence interval
         level
    		 97.5%
         sides
    1-sided
         lower limit
    		 -
         upper limit
    		 1.5
    Variability estimate
    Standard deviation
    Dispersion value
    4.26

    Secondary: Corneal Fluorescein Staining (CFS) Change From Baseline (First Key Secondary Endpoint)

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    End point title
    		 Corneal Fluorescein Staining (CFS) Change From Baseline (First Key Secondary Endpoint)
    End point description
    CSF Change from baseline in participants with baseline CSF score ≥ 1 at Week 12.
    End point type
    Secondary
    End point timeframe
    At Week 12
    End point values
    		 Period 1: DE-130A Period 1: Xalatan
    Number of subjects analysed
    80
    86
    Units: Score
        least squares mean (standard error)
    -0.71 ( 0.069 )
    -0.41 ( 0.077 )
    No statistical analyses for this end point

    Secondary: Ocular Surface Disease (OSD) Symptoms (Average of 3 Symptoms); Second Key Secondary Endpoint

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    End point title
    		 Ocular Surface Disease (OSD) Symptoms (Average of 3 Symptoms); Second Key Secondary Endpoint
    End point description
    Change from baseline in OSD symptom score (average of 3 symptoms: dry eye sensation,blurred/poor vision and burning/stinging/itching) in the study eye at Week 12 in patients with baseline symptom average score>0.
    End point type
    Secondary
    End point timeframe
    at Week 12
    End point values
    		 Period 1: DE-130A Period 1: Xalatan
    Number of subjects analysed
    99
    104
    Units: Score
        least squares mean (standard error)
    -0.26 ( 0.058 )
    -0.17 ( 0.060 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Information about AEs were collected from the signing of consent form until the end of the study.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    DE-130A
    Reporting group description
    		 -

    Reporting group title
    Xalatan
    Reporting group description
    		 -

    Reporting group title
    DE-130A/DE-130A
    Reporting group description
    		 -

    Reporting group title
    Xalatan/DE-130A
    Reporting group description
    		 -

    Serious adverse events
    		 DE-130A Xalatan DE-130A/DE-130A Xalatan/DE-130A
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 193 (0.52%)
    2 / 193 (1.04%)
    0 / 71 (0.00%)
    0 / 66 (0.00%)
         number of deaths (all causes)
    1
    0
    0
    0
         number of deaths resulting from adverse events
    1
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bladder cancer
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 193 (0.52%)
    0 / 71 (0.00%)
    0 / 66 (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
    Cardiac disorders
    Cardiac failure acute
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    0 / 71 (0.00%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary thrombosis
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 193 (0.52%)
    0 / 71 (0.00%)
    0 / 66 (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
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 DE-130A Xalatan DE-130A/DE-130A Xalatan/DE-130A
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    35 / 193 (18.13%)
    42 / 193 (21.76%)
    21 / 71 (29.58%)
    21 / 66 (31.82%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Blepharal papilloma
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    0 / 71 (0.00%)
    0 / 66 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 193 (0.00%)
    0 / 193 (0.00%)
    1 / 71 (1.41%)
    0 / 66 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Surgical and medical procedures
    Knee arthroplasty
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 193 (0.52%)
    0 / 71 (0.00%)
    0 / 66 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Dental implantation
         subjects affected / exposed
    0 / 193 (0.00%)
    0 / 193 (0.00%)
    0 / 71 (0.00%)
    1 / 66 (1.52%)
         occurrences all number
    0
    0
    0
    1
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    0 / 71 (0.00%)
    0 / 66 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Chest pain
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 193 (0.52%)
    0 / 71 (0.00%)
    0 / 66 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Fatigue
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 193 (0.52%)
    0 / 71 (0.00%)
    0 / 66 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Instillation site pain
         subjects affected / exposed
    0 / 193 (0.00%)
    3 / 193 (1.55%)
    0 / 71 (0.00%)
    1 / 66 (1.52%)
         occurrences all number
    0
    3
    0
    1
    Pain
         subjects affected / exposed
    0 / 193 (0.00%)
    0 / 193 (0.00%)
    0 / 71 (0.00%)
    1 / 66 (1.52%)
         occurrences all number
    0
    0
    0
    1
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    2 / 193 (1.04%)
    0 / 193 (0.00%)
    1 / 71 (1.41%)
    0 / 66 (0.00%)
         occurrences all number
    2
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    0 / 71 (0.00%)
    0 / 66 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Rhinorrhoea
         subjects affected / exposed
    1 / 193 (0.52%)
    1 / 193 (0.52%)
    0 / 71 (0.00%)
    0 / 66 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Investigations
    Blood cholesterol increased
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    0 / 71 (0.00%)
    0 / 66 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Body temperature increased
         subjects affected / exposed
    0 / 193 (0.00%)
    2 / 193 (1.04%)
    0 / 71 (0.00%)
    0 / 66 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Injury, poisoning and procedural complications
    Tooth fracture
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    0 / 71 (0.00%)
    0 / 66 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Contusion
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 193 (0.52%)
    0 / 71 (0.00%)
    0 / 66 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Skin laceration
         subjects affected / exposed
    0 / 193 (0.00%)
    0 / 193 (0.00%)
    1 / 71 (1.41%)
    0 / 66 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    0 / 71 (0.00%)
    0 / 66 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Atrial fibrillation
         subjects affected / exposed
    0 / 193 (0.00%)
    0 / 193 (0.00%)
    1 / 71 (1.41%)
    0 / 66 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Palpitations
         subjects affected / exposed
    0 / 193 (0.00%)
    0 / 193 (0.00%)
    1 / 71 (1.41%)
    0 / 66 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 193 (1.04%)
    1 / 193 (0.52%)
    0 / 71 (0.00%)
    0 / 66 (0.00%)
         occurrences all number
    2
    1
    0
    0
    Dysgeusia
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    0 / 71 (0.00%)
    0 / 66 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Eye disorders
    Ocular hyperaemia
         subjects affected / exposed
    3 / 193 (1.55%)
    5 / 193 (2.59%)
    2 / 71 (2.82%)
    2 / 66 (3.03%)
         occurrences all number
    3
    5
    2
    2
    Conjunctival hyperaemia
         subjects affected / exposed
    2 / 193 (1.04%)
    3 / 193 (1.55%)
    1 / 71 (1.41%)
    1 / 66 (1.52%)
         occurrences all number
    2
    3
    1
    1
    Dry eye
         subjects affected / exposed
    2 / 193 (1.04%)
    1 / 193 (0.52%)
    1 / 71 (1.41%)
    0 / 66 (0.00%)
         occurrences all number
    2
    1
    1
    0
    Erythema of eyelid
         subjects affected / exposed
    2 / 193 (1.04%)
    2 / 193 (1.04%)
    0 / 71 (0.00%)
    1 / 66 (1.52%)
         occurrences all number
    2
    2
    0
    1
    Keratitis
         subjects affected / exposed
    2 / 193 (1.04%)
    0 / 193 (0.00%)
    0 / 71 (0.00%)
    0 / 66 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Vision blurred
         subjects affected / exposed
    2 / 193 (1.04%)
    0 / 193 (0.00%)
    0 / 71 (0.00%)
    0 / 66 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Blepharitis
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    2 / 71 (2.82%)
    1 / 66 (1.52%)
         occurrences all number
    1
    0
    2
    1
    Chalazion
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    1 / 71 (1.41%)
    0 / 66 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Conjunctival haemorrhage
         subjects affected / exposed
    1 / 193 (0.52%)
    1 / 193 (0.52%)
    0 / 71 (0.00%)
    0 / 66 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Conjunctival oedema
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    0 / 71 (0.00%)
    0 / 66 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Eye pain
         subjects affected / exposed
    1 / 193 (0.52%)
    1 / 193 (0.52%)
    1 / 71 (1.41%)
    1 / 66 (1.52%)
         occurrences all number
    1
    1
    1
    2
    Eye pruritus
         subjects affected / exposed
    1 / 193 (0.52%)
    3 / 193 (1.55%)
    0 / 71 (0.00%)
    1 / 66 (1.52%)
         occurrences all number
    1
    3
    0
    1
    Eyelid oedema
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    0 / 71 (0.00%)
    0 / 66 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Growth of eyelashes
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    2 / 71 (2.82%)
    2 / 66 (3.03%)
         occurrences all number
    1
    0
    2
    2
    Ocular discomfort
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    0 / 71 (0.00%)
    0 / 66 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Swelling of eyelid
         subjects affected / exposed
    1 / 193 (0.52%)
    2 / 193 (1.04%)
    1 / 71 (1.41%)
    2 / 66 (3.03%)
         occurrences all number
    1
    3
    1
    3
    Abnormal sensation in eye
         subjects affected / exposed
    0 / 193 (0.00%)
    4 / 193 (2.07%)
    1 / 71 (1.41%)
    4 / 66 (6.06%)
         occurrences all number
    0
    4
    2
    4
    Eye irritation
         subjects affected / exposed
    0 / 193 (0.00%)
    2 / 193 (1.04%)
    0 / 71 (0.00%)
    0 / 66 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Foreign body sensation in eyes
         subjects affected / exposed
    0 / 193 (0.00%)
    3 / 193 (1.55%)
    0 / 71 (0.00%)
    1 / 66 (1.52%)
         occurrences all number
    0
    3
    0
    1
    Lacrimal disorder
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 193 (0.52%)
    0 / 71 (0.00%)
    0 / 66 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Vitreous detachment
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 193 (0.52%)
    1 / 71 (1.41%)
    0 / 66 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Cataract
         subjects affected / exposed
    0 / 193 (0.00%)
    0 / 193 (0.00%)
    1 / 71 (1.41%)
    0 / 66 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Eye paraesthesia
         subjects affected / exposed
    0 / 193 (0.00%)
    0 / 193 (0.00%)
    1 / 71 (1.41%)
    0 / 66 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Retinal haemorrhage
         subjects affected / exposed
    0 / 193 (0.00%)
    0 / 193 (0.00%)
    1 / 71 (1.41%)
    0 / 66 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Visual impairment
         subjects affected / exposed
    0 / 193 (0.00%)
    0 / 193 (0.00%)
    1 / 71 (1.41%)
    0 / 66 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Vitreous floaters
         subjects affected / exposed
    0 / 193 (0.00%)
    0 / 193 (0.00%)
    1 / 71 (1.41%)
    0 / 66 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Macular fibrosis
         subjects affected / exposed
    0 / 193 (0.00%)
    0 / 193 (0.00%)
    0 / 71 (0.00%)
    1 / 66 (1.52%)
         occurrences all number
    0
    0
    0
    1
    Photopsia
         subjects affected / exposed
    0 / 193 (0.00%)
    0 / 193 (0.00%)
    0 / 71 (0.00%)
    1 / 66 (1.52%)
         occurrences all number
    0
    0
    0
    1
    Gastrointestinal disorders
    Burning mouth syndrome
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    0 / 71 (0.00%)
    0 / 66 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Diarrhoea
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    0 / 71 (0.00%)
    0 / 66 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 193 (0.52%)
    0 / 71 (0.00%)
    0 / 66 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Hyperkeratosis
         subjects affected / exposed
    0 / 193 (0.00%)
    0 / 193 (0.00%)
    1 / 71 (1.41%)
    0 / 66 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 193 (1.55%)
    1 / 193 (0.52%)
    0 / 71 (0.00%)
    1 / 66 (1.52%)
         occurrences all number
    3
    1
    0
    1
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    1 / 71 (1.41%)
    0 / 66 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Pain in extremity
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    0 / 71 (0.00%)
    0 / 66 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Back pain
         subjects affected / exposed
    0 / 193 (0.00%)
    3 / 193 (1.55%)
    0 / 71 (0.00%)
    2 / 66 (3.03%)
         occurrences all number
    0
    3
    0
    2
    Mobility decreased
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 193 (0.52%)
    0 / 71 (0.00%)
    1 / 66 (1.52%)
         occurrences all number
    0
    1
    0
    1
    Osteoarthritis
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 193 (0.52%)
    1 / 71 (1.41%)
    1 / 66 (1.52%)
         occurrences all number
    0
    1
    1
    1
    Plantar fasciitis
         subjects affected / exposed
    0 / 193 (0.00%)
    0 / 193 (0.00%)
    1 / 71 (1.41%)
    0 / 66 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Tendon disorder
         subjects affected / exposed
    0 / 193 (0.00%)
    0 / 193 (0.00%)
    1 / 71 (1.41%)
    0 / 66 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Spinal pain
         subjects affected / exposed
    0 / 193 (0.00%)
    0 / 193 (0.00%)
    0 / 71 (0.00%)
    1 / 66 (1.52%)
         occurrences all number
    0
    0
    0
    1
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    0 / 71 (0.00%)
    0 / 66 (0.00%)
         occurrences all number
    1
    0
    0
    0
    COVID-19
         subjects affected / exposed
    1 / 193 (0.52%)
    2 / 193 (1.04%)
    0 / 71 (0.00%)
    4 / 66 (6.06%)
         occurrences all number
    1
    2
    0
    4
    Influenza
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    1 / 71 (1.41%)
    0 / 66 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 193 (0.52%)
    2 / 193 (1.04%)
    0 / 71 (0.00%)
    0 / 66 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Subcutaneous abscess
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    0 / 71 (0.00%)
    0 / 66 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Tooth infection
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    0 / 71 (0.00%)
    0 / 66 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Cystitis
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 193 (0.52%)
    0 / 71 (0.00%)
    0 / 66 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Genital infection
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 193 (0.52%)
    0 / 71 (0.00%)
    0 / 66 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Labyrinthitis
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 193 (0.52%)
    0 / 71 (0.00%)
    0 / 66 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 193 (0.52%)
    0 / 71 (0.00%)
    0 / 66 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Respiratory tract infection viral
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 193 (0.52%)
    0 / 71 (0.00%)
    0 / 66 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Conjunctivitis
         subjects affected / exposed
    0 / 193 (0.00%)
    0 / 193 (0.00%)
    1 / 71 (1.41%)
    0 / 66 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Conjunctivitis viral
         subjects affected / exposed
    0 / 193 (0.00%)
    0 / 193 (0.00%)
    1 / 71 (1.41%)
    0 / 66 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Ear infection
         subjects affected / exposed
    0 / 193 (0.00%)
    0 / 193 (0.00%)
    1 / 71 (1.41%)
    0 / 66 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Herpes simplex
         subjects affected / exposed
    0 / 193 (0.00%)
    0 / 193 (0.00%)
    1 / 71 (1.41%)
    0 / 66 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hordeolum
         subjects affected / exposed
    0 / 193 (0.00%)
    0 / 193 (0.00%)
    1 / 71 (1.41%)
    0 / 66 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Rhinitis
         subjects affected / exposed
    0 / 193 (0.00%)
    0 / 193 (0.00%)
    1 / 71 (1.41%)
    1 / 66 (1.52%)
         occurrences all number
    0
    0
    1
    1
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 193 (0.00%)
    0 / 193 (0.00%)
    1 / 71 (1.41%)
    0 / 66 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Coronavirus infection
         subjects affected / exposed
    0 / 193 (0.00%)
    0 / 193 (0.00%)
    0 / 71 (0.00%)
    1 / 66 (1.52%)
         occurrences all number
    0
    0
    0
    1
    Metabolism and nutrition disorders
    Gout
         subjects affected / exposed
    0 / 193 (0.00%)
    0 / 193 (0.00%)
    1 / 71 (1.41%)
    0 / 66 (0.00%)
         occurrences all number
    0
    0
    1
    0

    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
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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
    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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