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    Clinical Trial Results:
    Prophylactic effect of brimonidine on bleeding subconjunctival in 23G vitrectomy

    Summary
    EudraCT number
    		 2012-002895-15
    Trial protocol
    		 ES  
    Global end of trial date
    07 Dec 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 May 2022
    First version publication date
    08 May 2022
    Other versions
    Summary report(s)
    		 Final Report EPROBRI

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    EPROBRI-2011
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Fundación Oftalmológica del Mediterráneo
    Sponsor organisation address
    Avenida Pío Baroja, 12, Valencia, Spain, 46015
    Public contact
    Departamento Ensayos Clínicos, Fundación Oftalmológica del Mediterráneo, +0034 96278 76 20, baron_margar@gva.es
    Scientific contact
    Departamento Ensayos Clínicos, Fundación Oftalmológica del Mediterráneo, +0034 96278 76 20, baron_margar@gva.es
    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
    16 Nov 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Dec 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Dec 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine if it can be prevented and in that percentage the appearance of subconjunctival haemorrhages after surgery of vitrectomía with 23G, by means of the use of brimonidina in collyrium in the preoperative medication.
    Protection of trial subjects
    The medical personnel who will handle the medications as well as the patients have the necessary training for their participation in the clinical trial. Serious adverse events are not expected to occur in patients. If so, the medical personnel are prepared to face them and the necessary measures will be taken corresponding to the nature and intensity of the event.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Mar 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: 80
    Worldwide total number of subjects
    80
    EEA total number of subjects
    80
    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)
    19
    From 65 to 84 years
    59
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients who are going to undergo a 23G vitrectomy. Recruitment period: 3 years (2014-2016) Territories only in Spain. FISABIO OFTALMOLOGIA MEDICA

    Pre-assignment
    Screening details
    		 Patients who are going to undergo a 23G vitrectomy (2014-2016).

    Period 1
    Period 1 title
    OVERALL TRIAL (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1: Alfadine treatment group
    Arm description
    		 Group 1, Alfadine treatment group: They will be administered 2 drops of the medication 15 minutes before surgery and another round 5 minutes before, in addition to the usual preoperative ones. Brimonidine eye drops have been supplied by Bausch & Lomb.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Brimonidine tartrate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    2 drops of the medication 15 minutes before surgery and another round 5 minutes before, in addition to the usual preoperative ones.

    Arm title
    		 Group 2: control group
    Arm description
    		 Group 2, control group: Only the usual preoperative drops will be instilled.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    study treatment drops are not instilled, only the usual preoperative drops will be instilled.

    Number of subjects in period 1
    		Group 1: Alfadine treatment group Group 2: control group
    Started
    42
    38
    Completed
    41
    36
    Not completed
    1
    2
         Adverse event, non-fatal
    -
    1
         bleeding is evidenced before surgery
    -
    1
         before surgery there is evidence of bleeding
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group 1: Alfadine treatment group
    Reporting group description
    		 Group 1, Alfadine treatment group: They will be administered 2 drops of the medication 15 minutes before surgery and another round 5 minutes before, in addition to the usual preoperative ones. Brimonidine eye drops have been supplied by Bausch & Lomb.

    Reporting group title
    Group 2: control group
    Reporting group description
    		 Group 2, control group: Only the usual preoperative drops will be instilled.

    Reporting group values
    		 Group 1: Alfadine treatment group Group 2: control group Total
    Number of subjects
    		 42 38 80
    Age categorical
    The sample is finally made up of 77 patients who underwent 23G vitrectomy surgery in PHYSABIO-OPHTHALMOLOGY by the team of surgeons from the vitreo-retina unit. A total of 39 men (50.6%) and 38 women (49.4%) participated in the study, with a mean age of 68.4 ± 10.7 years and a range between 28 and 86 years. The trial period was from February 2013 to December 2016. The patients were divided into 2 treated groups and controls, according to the treatment with brimonidine (n = 41) or not (n = 36). This work is a prospective controlled study with a 2-week follow-up and data recording at baseline
    Units: Subjects
        Adults (18-64 years)
    		 12 7 19
        From 65-84 years
    		 29 29 58
        85 years and over
    		 1 2 3
    Gender categorical
    The secondary variables are: age, sex, if the patient is hypertensive, if he is diabetic, takes anticoagulants or antiaggregants. This same model will be used to evaluate the influence of other demographic and clinical factors.
    Units: Subjects
        Female
    		 20 18 38
        Male
    		 22 20 42
    Number of bleeding quadrants
    Evolution of the incidence of bleeding After surgery and the first 3 days, the rate of patients with subconjunctival hemorrhage is similar, there is only a statistical trend, with the percentage of bleeding being higher in the group of untreated patients. It is in the last visit where certain statistically significant differences are appreciated: 7.3% of eyes in the drug group presented subconjunctival hemorrhage, compared to 28.6% among the controls. Brimonidine treatment reduces the risk of bleeding by 80.3% compared to a control at the end of follow-up. The following conclusions are draw
    Units: Subjects
        bleeding quadrants
    		 42 38 80
    Evolution of the number of affected quadrants
    More than the incidence of bleeding, the number of quadrants affected is the main answer to evaluate the effect of brimonidine; since it adds to the first, the nuance of the scope of the alteration. Table 3 describes in detail the observed distribution, which is graphically summarized in Figure 2: In terms of the number of quadrants, it is noted (descriptively) that the control subjects have a greater predisposition to a greater number of quadrants affected by subconjunctival hemorrhage, than in the group treated with brimonidine. It is accepted that in T2 the distributions of the number of
    Units: Subjects
        affected quadrants
    		 42 38 80
    Antiplatelet
    We will present the results of this subgroup of patients, taking into account that the n is low: 6 patients with antiplatelet agents in the control group and 7 patients in the group treated with brimonidine. According to the protocols of the anesthetists at the center, low-dose antiplatelet agents (eg, ADIRO 100) are not withdrawn before surgery, they are only withdrawn when the dose is higher (eg ADIRO 300, TROMALYT). Treatment with brimonidine does not specifically improve in an added way in patients who are antiaggregated, because they do not bleed more after 23G vitreoretinal surgery.
    Units: Subjects
        Antiplatelet
    		 42 38 80
    Anticoagulants
    In this group, the n is very low: 4 patients in the control group and 3 patients in the brimonidine treatment group, so the results are not conclusive. We will still expose them. According to the protocols of the anesthetists of the center, the anticoagulants are withdrawn before surgery and are replaced by low molecular weight heparins. Most outstanding is the significant triple interaction (p = 0.033). In this case, it is the slight worsening of the response in the controls taking anticoagulants that causes statistical significance. Treatment with brimonidine specifically improves
    Units: Subjects
        Anticoagulants
    		 42 38 80
    Arterial hypertension
    Of the total sample size, 49.4% (n 38) of the patients did not have HT, compared to 50.9% (n 39) who did suffer from this disease. The Brunner-Langer model shows that there is no relevant effect attributable to the arterial hypertension diagnosis in terms of subconjunctival hemorrhage after 23G vitrectomy.
    Units: Subjects
        Arterial hypertension
    		 42 38 80
    Diabetes Mellitus (DM)
    Of the total of patients included in this study (n = 77), only 26 were diabetic, 6 were type I and 20 were type II. The Brunner-Langer model shows that there is no relevant effect attributable to the diagnosis of diabetes in terms of subconjunctival hemorrhage after 23G vitrectomy. If we do the analysis by type of diabetes, type I or type II, we also do not find any statistically significant results.
    Units: Subjects
        Diabetes Mellitus
    		 42 38 80
    Conjunctival rupture after vitrectomy
    When analyzing these variables on the effect of subconjunctival hemorrhage and the prophylactic effect of brimonidine, it is evident that there are no differences associated with the fact that a conjunctival rupture has occurred or not. When we analyze the fact of having sutured the conjunctiva, no differences are found associated with the application of suture or not, but there is evidence of an important trend, since in patients who have had their sclerotomy sutured, the number of quadrants with hemorrhage subconjunctival is greater, as is logical due to the trauma on the conjunctiva.
    Units: Subjects
        Conjunctival rupture
    		 42 38 80
    Evolution of the size of the lesion
    Regarding the outcomes of interest, the size of the subconjunctival hemorrhage (in those patients where there was) is also representative of its scope. Remember that the maximum diameter of the smallest lesion has been considered as size large of the 4 quadrants. It is therefore accepted that at any time the size of the hemorrhage is similar in both groups.
    Units: Subjects
        size of the lesion
    		 42 38 80
    Sclerotomy suture after vitrectomy
    When analyzing these variables on the effect of subconjunctival hemorrhage and the prophylactic effect of brimonidine, no differences are found associated with the application of suture or not, but there is evidence of an important trend, since in patients who have had their sclerotomy sutured, the number of quadrants with hemorrhage subconjunctival is greater, as is logical due to the trauma on the conjunctiva.
    Units: Subjects
        sclerotomy suture
    		 42 38 80
    Subject analysis sets

    Subject analysis set title
    Treatment with tartrate brimonidine
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The presence of subconjunctival hemorrhage after 23G vitrectomy is lower in the group treated with brimonidine throughout the follow-up time, but the difference is much greater at the end of the follow-up. Treatment with brimonidine reduces the risk of bleeding by 80.3% compared to a control at one week of follow-up. The number of quadrants affected by subconjunctival hemorrhage is similar between treated and untreated during the first 3 days; but at one week the number of quadrants affected by bleeding is statistically lower in the group treated with brimonidine. The prophylactic role against subconjunctival hemorrhage after PPV 23G of brimonidine in patients taking antiaggregants has not been demonstrated, but it has been demonstrated in anticoagulated patients. No associated beneficial role of prophylactic treatment with brimonidine against subconjunctival hemorrhage has been demonstrated in 23G PPV in hypertensive patients or in diabetics.

    Subject analysis set title
    Without treartment
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Control group: Only the usual preoperative drops will be instilled.

    Subject analysis sets values
    		 Treatment with tartrate brimonidine Without treartment
    Number of subjects
    41
    36
    Age categorical
    The sample is finally made up of 77 patients who underwent 23G vitrectomy surgery in PHYSABIO-OPHTHALMOLOGY by the team of surgeons from the vitreo-retina unit. A total of 39 men (50.6%) and 38 women (49.4%) participated in the study, with a mean age of 68.4 ± 10.7 years and a range between 28 and 86 years. The trial period was from February 2013 to December 2016. The patients were divided into 2 treated groups and controls, according to the treatment with brimonidine (n = 41) or not (n = 36). This work is a prospective controlled study with a 2-week follow-up and data recording at baseline
    Units: Subjects
        Adults (18-64 years)
    12
    7
        From 65-84 years
    28
    28
        85 years and over
    1
    1
    Age continuous
    Units:
        
    ±
    ±
    Gender categorical
    The secondary variables are: age, sex, if the patient is hypertensive, if he is diabetic, takes anticoagulants or antiaggregants. This same model will be used to evaluate the influence of other demographic and clinical factors.
    Units: Subjects
        Female
    20
    18
        Male
    21
    18
    Number of bleeding quadrants
    Evolution of the incidence of bleeding After surgery and the first 3 days, the rate of patients with subconjunctival hemorrhage is similar, there is only a statistical trend, with the percentage of bleeding being higher in the group of untreated patients. It is in the last visit where certain statistically significant differences are appreciated: 7.3% of eyes in the drug group presented subconjunctival hemorrhage, compared to 28.6% among the controls. Brimonidine treatment reduces the risk of bleeding by 80.3% compared to a control at the end of follow-up. The following conclusions are draw
    Units: Subjects
        bleeding quadrants
    4
    4
    Evolution of the number of affected quadrants
    More than the incidence of bleeding, the number of quadrants affected is the main answer to evaluate the effect of brimonidine; since it adds to the first, the nuance of the scope of the alteration. Table 3 describes in detail the observed distribution, which is graphically summarized in Figure 2: In terms of the number of quadrants, it is noted (descriptively) that the control subjects have a greater predisposition to a greater number of quadrants affected by subconjunctival hemorrhage, than in the group treated with brimonidine. It is accepted that in T2 the distributions of the number of
    Units: Subjects
        affected quadrants
    2
    2
    Antiplatelet
    We will present the results of this subgroup of patients, taking into account that the n is low: 6 patients with antiplatelet agents in the control group and 7 patients in the group treated with brimonidine. According to the protocols of the anesthetists at the center, low-dose antiplatelet agents (eg, ADIRO 100) are not withdrawn before surgery, they are only withdrawn when the dose is higher (eg ADIRO 300, TROMALYT). Treatment with brimonidine does not specifically improve in an added way in patients who are antiaggregated, because they do not bleed more after 23G vitreoretinal surgery.
    Units: Subjects
        Antiplatelet
    41
    36
    Anticoagulants
    In this group, the n is very low: 4 patients in the control group and 3 patients in the brimonidine treatment group, so the results are not conclusive. We will still expose them. According to the protocols of the anesthetists of the center, the anticoagulants are withdrawn before surgery and are replaced by low molecular weight heparins. Most outstanding is the significant triple interaction (p = 0.033). In this case, it is the slight worsening of the response in the controls taking anticoagulants that causes statistical significance. Treatment with brimonidine specifically improves
    Units: Subjects
        Anticoagulants
    41
    36
    Arterial hypertension
    Of the total sample size, 49.4% (n 38) of the patients did not have HT, compared to 50.9% (n 39) who did suffer from this disease. The Brunner-Langer model shows that there is no relevant effect attributable to the arterial hypertension diagnosis in terms of subconjunctival hemorrhage after 23G vitrectomy.
    Units: Subjects
        Arterial hypertension
    21
    18
    Diabetes Mellitus (DM)
    Of the total of patients included in this study (n = 77), only 26 were diabetic, 6 were type I and 20 were type II. The Brunner-Langer model shows that there is no relevant effect attributable to the diagnosis of diabetes in terms of subconjunctival hemorrhage after 23G vitrectomy. If we do the analysis by type of diabetes, type I or type II, we also do not find any statistically significant results.
    Units: Subjects
        Diabetes Mellitus
    14
    12
    Conjunctival rupture after vitrectomy
    When analyzing these variables on the effect of subconjunctival hemorrhage and the prophylactic effect of brimonidine, it is evident that there are no differences associated with the fact that a conjunctival rupture has occurred or not. When we analyze the fact of having sutured the conjunctiva, no differences are found associated with the application of suture or not, but there is evidence of an important trend, since in patients who have had their sclerotomy sutured, the number of quadrants with hemorrhage subconjunctival is greater, as is logical due to the trauma on the conjunctiva.
    Units: Subjects
        Conjunctival rupture
    41
    36
    Evolution of the size of the lesion
    Regarding the outcomes of interest, the size of the subconjunctival hemorrhage (in those patients where there was) is also representative of its scope. Remember that the maximum diameter of the smallest lesion has been considered as size large of the 4 quadrants. It is therefore accepted that at any time the size of the hemorrhage is similar in both groups.
    Units: Subjects
        size of the lesion
    Sclerotomy suture after vitrectomy
    When analyzing these variables on the effect of subconjunctival hemorrhage and the prophylactic effect of brimonidine, no differences are found associated with the application of suture or not, but there is evidence of an important trend, since in patients who have had their sclerotomy sutured, the number of quadrants with hemorrhage subconjunctival is greater, as is logical due to the trauma on the conjunctiva.
    Units: Subjects
        sclerotomy suture
    41
    36

    End points

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    End points reporting groups
    Reporting group title
    Group 1: Alfadine treatment group
    Reporting group description
    		 Group 1, Alfadine treatment group: They will be administered 2 drops of the medication 15 minutes before surgery and another round 5 minutes before, in addition to the usual preoperative ones. Brimonidine eye drops have been supplied by Bausch & Lomb.

    Reporting group title
    Group 2: control group
    Reporting group description
    		 Group 2, control group: Only the usual preoperative drops will be instilled.

    Subject analysis set title
    Treatment with tartrate brimonidine
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The presence of subconjunctival hemorrhage after 23G vitrectomy is lower in the group treated with brimonidine throughout the follow-up time, but the difference is much greater at the end of the follow-up. Treatment with brimonidine reduces the risk of bleeding by 80.3% compared to a control at one week of follow-up. The number of quadrants affected by subconjunctival hemorrhage is similar between treated and untreated during the first 3 days; but at one week the number of quadrants affected by bleeding is statistically lower in the group treated with brimonidine. The prophylactic role against subconjunctival hemorrhage after PPV 23G of brimonidine in patients taking antiaggregants has not been demonstrated, but it has been demonstrated in anticoagulated patients. No associated beneficial role of prophylactic treatment with brimonidine against subconjunctival hemorrhage has been demonstrated in 23G PPV in hypertensive patients or in diabetics.

    Subject analysis set title
    Without treartment
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Control group: Only the usual preoperative drops will be instilled.

    Primary: Primary Objective

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    End point title
    		 Primary Objective
    End point description
    End point type
    Primary
    End point timeframe
    Primary Objective: determine if the appearance of subconjunctival hemorrhages after 23G vitrectomy surgery can be prevented and in what percentage, by using brimonidine eye drops in preoperative medication.
    End point values
    		 Group 1: Alfadine treatment group Group 2: control group
    Number of subjects analysed
    42
    38
    Units: percentage of subconjunctival hemorrhage
        number (not applicable)
    7
    29
    Statistical analysis title
    		 Brunner-Langer model ATS test.
    Statistical analysis description
    After surgery and the first 3 days, the rate of patients with subconjunctival hemorrhage is similar, there is only a statistical trend, with the percentage of bleeding being higher in the group of untreated patients. It is in the last visit where certain statistically significant differences are appreciated: 7.3% of eyes in the drug group presented subconjunctival hemorrhage, compared to 28.6% among the controls.
    Comparison groups
    Group 1: Alfadine treatment group v Group 2: control group
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 < 0.001 [2]
    Method
    		 Chi-squared
    Parameter type
    		 Odds ratio (OR)
    Confidence interval
    Notes
    [1] - Percentage of affected and odds ratio (OR) of the association and Chi2 test at each time. Brunner-Langer model ATS test.
    [2] - The following conclusions are drawn from the estimated Brunner-Langer model:  There is an evident time effect (p <0.001): the probability of bleeding decreases significantly over time.

    Secondary: Secondary objective - antiaggregants

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    End point title
    		 Secondary objective - antiaggregants
    End point description
    If the patient is taking antiaggregants.
    End point type
    Secondary
    End point timeframe
    Secondary objective: The secondary objective will be to try to determine if there are individual preconditions that alter the response.
    End point values
    		 Group 1: Alfadine treatment group Group 2: control group
    Number of subjects analysed
    42 [3]
    38 [4]
    Units: number of patients
        number (not applicable)
    7
    6
    Notes
    [3] - Patients taking antiaggregant
    [4] - Patients taking antiaggregants
    Statistical analysis title
    		 Brunner-Larger
    Comparison groups
    Group 1: Alfadine treatment group v Group 2: control group
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.049
    Method
    		 Test ATS
    Confidence interval

    Secondary: Secondary objective - anticoagulants

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    End point title
    		 Secondary objective - anticoagulants
    End point description
    If the patient is taking anticoagulants.
    End point type
    Secondary
    End point timeframe
    Secondary objective: The secondary objective will be to try to determine if there are individual preconditions that alter the response.
    End point values
    		 Group 1: Alfadine treatment group Group 2: control group
    Number of subjects analysed
    42 [5]
    38 [6]
    Units: number of patient
        number (not applicable)
    3
    4
    Notes
    [5] - Patient taking anticoagulants.
    [6] - Patient taking anticoagulants.
    Statistical analysis title
    		 Brunner-Larger
    Comparison groups
    Group 1: Alfadine treatment group v Group 2: control group
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.033
    Method
    		 Test ATS
    Confidence interval

    Secondary: Secondary objective - Diabetic

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    End point title
    		 Secondary objective - Diabetic
    End point description
    Diabetic patients
    End point type
    Secondary
    End point timeframe
    Secondary objective: The secondary objective will be to try to determine if there are individual preconditions that alter the response.
    End point values
    		 Group 1: Alfadine treatment group Group 2: control group
    Number of subjects analysed
    42 [7]
    38 [8]
    Units: number of patients
        number (not applicable)
    9
    4
    Notes
    [7] - Diabetic patients
    [8] - Diabetic patients
    Statistical analysis title
    		 Brunner-Larger
    Comparison groups
    Group 1: Alfadine treatment group v Group 2: control group
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.659
    Method
    		 Test ATS
    Confidence interval

    Secondary: Secondary objective - Arterial hypertension

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    End point title
    		 Secondary objective - Arterial hypertension
    End point description
    Arterial hypertension patients.
    End point type
    Secondary
    End point timeframe
    Secondary objective: The secondary objective will be to try to determine if there are individual preconditions that alter the response.
    End point values
    		 Group 1: Alfadine treatment group Group 2: control group
    Number of subjects analysed
    42 [9]
    38 [10]
    Units: number of patients
        number (not applicable)
    15
    13
    Notes
    [9] - Arterila hypertension patients.
    [10] - Arterial hypertension patients.
    Statistical analysis title
    		 Brunner-Larger
    Comparison groups
    Group 1: Alfadine treatment group v Group 2: control group
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.633
    Method
    		 Test ATS
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    No adverse effect or serious adverse effect were recorded throughout the development of the trial.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Control Group
    Reporting group description
    		 control group: Only the usual preoperative drops will be instilled.

    Serious adverse events
    		 Control Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Control Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 1 (100.00%)
    Injury, poisoning and procedural complications
    the patient had a fall and was unable to come to visits
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/34632270
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