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    Clinical Trial Results:
    A Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Repeated Administration, Crossover Study to Establish Safety, Tolerability, and Efficacy of PresbiDrops in Presbyopic Subjects

    Summary
    EudraCT number
    		 2016-001091-30
    Trial protocol
    		 SI  
    Global end of trial date
    26 Jun 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Aug 2019
    First version publication date
    24 Aug 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    FG-PRE-101
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Orasis
    Sponsor organisation address
    Maskit, Herzliya, Israel, 4673312
    Public contact
    Elad Kedar, CEO, ORASIS Pharmaceuticals Ltd, 972 98877745, elad.kedar@orasis-pharma.com
    Scientific contact
    Elad Kedar, CEO, ORASIS Pharmaceuticals Ltd, 972 98877745, elad.kedar@orasis-pharma.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
    25 Jul 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Jul 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Jun 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary To establish safety and tolerability of repeated administration of PresbiDrops in presbyopic subjects
    Protection of trial subjects
    1. 24/7 availability of principal investigators 2. Medical experts available on behalf of the company and from insurance coverage
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 May 2016
    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
    Slovenia: 13
    Country: Number of subjects enrolled
    Israel: 24
    Worldwide total number of subjects
    37
    EEA total number of subjects
    13
    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)
    37
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Screening assessments was conducted within a 21-day period prior to the start of therapy, including demographics, medical history, concomitant medication recording, urine pregnancy test (for females of childbearing potential), and ophthalmic examinations.

    Pre-assignment period milestones
    Number of subjects started
    		 37
    Number of subjects completed
    		 37

    Period 1
    Period 1 title
    Treatment Phase
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Assessor
    Blinding implementation details
    Treatment order (investigational product or placebo) was dependent on randomization sequence assignment. Eligible subjects were randomly assigned in a 1:1 ratio to one of two treatment sequences of multiple administrations of drug and placebo. A master randomization list was generated by MediStat, Ltd., indexed by randomization number.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 treatment 1
    Arm description
    		 PresbiDrops followed by placebo
    Arm type
    		 Experimental

    Investigational medicinal product name
    Presbidrops
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops, solution
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    self-administered by the subject over two weeks (one drop in each eye every morning)

    Investigational medicinal product name
    Placebo for presbidrops
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Ear/eye drops, solution
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    one drop per eye

    Arm title
    		 treatment 2
    Arm description
    		 placebo followed by PresbiDrops
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo for presbidrops
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Ear/eye drops, solution
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    one drop per eye

    Investigational medicinal product name
    Presbidrops
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops, solution
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    self-administered by the subject over two weeks (one drop in each eye every morning)

    Number of subjects in period 1
    		treatment 1 treatment 2
    Started
    18
    19
    Completed
    15
    19
    Not completed
    3
    0
         Lost to follow-up
    3
    -
    Period 2
    Period 2 title
    Follow up period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 treatment 1
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Presbidrops
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops, solution
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    self-administered by the subject over two weeks (one drop in each eye every morning)

    Arm title
    		 placebo
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Presbidrops
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops, solution
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    self-administered by the subject over two weeks (one drop in each eye every morning)

    Number of subjects in period 2
    		treatment 1 placebo
    Started
    15
    19
    Completed
    15
    19

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment Phase
    Reporting group description
    		 -

    Reporting group values
    		 Treatment Phase Total
    Number of subjects
    		 37 37
    Age categorical
    Men and women between 40 and 65 years of age (inclusive)
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 37 37
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Mean - 51.3, SD - 4.6
    Units: years
        arithmetic mean (standard deviation)
    		 51.3 ( 4.6 ) -
    Gender categorical
    Units: Subjects
        Female
    		 22 22
        Male
    		 15 15

    End points

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    End points reporting groups
    Reporting group title
    treatment 1
    Reporting group description
    		 PresbiDrops followed by placebo

    Reporting group title
    treatment 2
    Reporting group description
    		 placebo followed by PresbiDrops
    Reporting group title
    treatment 1
    Reporting group description
    		 -

    Reporting group title
    placebo
    Reporting group description
    		 -

    Primary: 2 line improvement - treatment vs. placebo

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    End point title
    		 2 line improvement - treatment vs. placebo
    End point description
    End point type
    Primary
    End point timeframe
    Study duration
    End point values
    		 treatment 1 treatment 2
    Number of subjects analysed
    15
    19
    Units: percent
        number (not applicable)
    15
    19
    Statistical analysis title
    		 Rate of responders by treatment
    Comparison groups
    treatment 1 v treatment 2
    Number of subjects included in analysis
    34
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs were collected throughout the study starting from Baseline through the Follow-up visit- 45 days
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Presbidrops
    Reporting group description
    		 Each participant received presbidrops during the study

    Reporting group title
    Placebo for presbidrops
    Reporting group description
    		 Every subject received placebo for presbidrops

    Serious adverse events
    		 Presbidrops Placebo for presbidrops
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 37 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Presbidrops Placebo for presbidrops
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    28 / 37 (75.68%)
    23 / 37 (62.16%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 37 (8.11%)
    0 / 37 (0.00%)
         occurrences all number
    3
    0
    General disorders and administration site conditions
    Administration site discomfort
         subjects affected / exposed
    5 / 37 (13.51%)
    5 / 37 (13.51%)
         occurrences all number
    5
    5
    Eye disorders
    Conjunctival hyperaemia
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    Administration site dryness
         subjects affected / exposed
    3 / 37 (8.11%)
    0 / 37 (0.00%)
         occurrences all number
    4
    0
    Burning sensation
         subjects affected / exposed
    16 / 37 (43.24%)
    4 / 37 (10.81%)
         occurrences all number
    37
    4
    Administration site pain
         subjects affected / exposed
    7 / 37 (18.92%)
    2 / 37 (5.41%)
         occurrences all number
    13
    2
    Vision blurred
         subjects affected / exposed
    22 / 37 (59.46%)
    20 / 37 (54.05%)
         occurrences all number
    51
    40

    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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