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    Summary
    EudraCT Number:2010-023917-68
    Sponsor's Protocol Code Number:192024-054
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-05-09
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2010-023917-68
    A.3Full title of the trial
    A 2-year, multicenter, double-masked, randomized, parallel study of the safety of LUMIGAN 0.1 mg/mL compared with LUMIGAN 0.3 mg/mL in patients with glaucoma or ocular hypertension
    A.3.2Name or abbreviated title of the trial where available
    LUMIGAN 0.1 mg/mL compared with LUMIGAN 0.3 mg/mL in patient with glaucoma or ocular
    A.4.1Sponsor's protocol code number192024-054
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorALLERGAN LTD
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name LUMIGAN*COLL FL 3ML 0,1MG/ML
    D.2.1.1.2Name of the Marketing Authorisation holderALLERGAN SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Eye drops, solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOcular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBimatoprost
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number.1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name LUMIGAN*COLL FL 3ML 0,3MG/ML
    D.2.1.1.2Name of the Marketing Authorisation holderALLERGAN SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Eye drops, solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOcular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBimatoprost
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number.3
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    To evaluate the long-term safety of LUM 0.01% compared with
    LUM 0.03% administered once daily for 2 years in patients with
    glaucoma or ocular hypertension
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level LLT
    E.1.2Classification code 10020784
    E.1.2Term Hypertension ocular
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level PT
    E.1.2Classification code 10015943
    E.1.2Term Eye inflammation
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the long-term safety of LUM 0.01% compared with
    LUM 0.03% administered once daily for 2 years in patients with
    glaucoma or ocular hypertension
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female, at least 18 years of age and of legal age of consent
    2. Patient has either OHT, primary open-angle glaucoma, chronic angle-closure
    glaucoma with patent iridotomy/iridectomy, pseudoexfoliative glaucoma, or
    pigmentary glaucoma in each eye
    3. Patient requires bilateral IOP-lowering therapy and his/her IOP is likely to be
    controlled on bimatoprost monotherapy
    4. Baseline: A best-corrected visual acuity score equivalent to a Snellen acuity of 20/100
    or better in each eye, using a logarithmic visual acuity chart for testing at 10 feet
    (3 meters)
    5. Baseline: Negative urine pregnancy test for females of childbearing potential prior to
    randomization
    6. Written informed consent has been obtained prior to any study procedures
    7. Patient is able and willing to follow study instructions and likely to complete all
    required visits
    8. Written documentation has been obtained in accordance with the relevant country and
    local privacy requirements, where applicable (eg, written Data Protection consent
    [sites in European Union]).
    E.4Principal exclusion criteria
    1. Uncontrolled systemic disease
    2. Females who are pregnant, nursing, or planning a pregnancy or females of
    childbearing potential, not using a reliable method of contraception. A female is
    considered to be of childbearing potential unless she is without a uterus or is
    post-menopausal and has been amenorrheic for at least 12 consecutive months.
    3. Patients with advanced ocular surface disease (eg, dry eye) or in whom the cornea is
    compromised
    4. Previous suspected adverse reaction to either PGA or to BAK exposure that has led to
    discontinuation of medication
    5. Known allergy or hypersensitivity to the study medication or its components
    6. Allergy or contraindication to the use of topical fluorescein, lissamine green or any
    other diagnostic agent needed for study examination procedures
    7. Active or recurrent ocular disease (eg, uveitis, ocular infections, chronic blepharitis,
    or moderate to severe dry eye), that in the opinion of the investigator would interfere
    with the interpretation of the study data
    8. Known chronic exposure to causes of ocular surface irritation (eg, smoke, chlorine)
    9. History of recurrent ocular seasonal allergies within the past 2 years
    10. Qualification/baseline (day 1): Active ocular surface findings (such as hyperaemia,
    irritation, dryness [including that associated with trabeculectomy blebs or drainage
    tubes, such as corneal dellen, etc]) equal to +1 (mild) or greater in either eye found on
    gross macroscopic hyperaemia or slit-lamp examination
    11. Required chronic use of ocular medications during the study other than the study
    medication. Note: Intermittent use of artificial tear products are allowed, but not
    within 24 hours of a scheduled visit. Intermittent use of ocular decongestants or
    antihistamines is allowed, but not within 2 weeks of a scheduled visit
    12. Corneal or other ocular abnormalities that would preclude accurate readings with an
    applanation tonometer
    13. Patient’s IOP was previously uncontrolled on bimatoprost monotherapy
    14. History of severe ocular trauma
    15. History (within 3 months prior to qualification/baseline [day 1]) of ocular laser,
    intraocular, filtering or refractive surgery or planned ocular surgery of any kind at
    entry (qualification/baseline)
    16. Visual field loss which in the opinion of the investigator is functionally significant or
    evidence of progressive visual field loss within the year prior to qualification/baseline
    (day 1)
    17. Contraindication to pupil dilation
    18. Anticipated wearing of contact lenses during the study (after signing informed
    consent, use of soft lenses should be discontinued at least 2 days prior to
    qualification/baseline [day 1], and use of rigid gas permeable [RGP] or hard contact
    lenses should be discontinued at least 1 week prior to qualification/baseline [day 1])
    19. Current enrollment in an investigational drug or device study or participation in such
    a study within 30 days prior to qualification/baseline (day 1)
    20. Patient has a condition or is in a situation which, in the investigator’s opinion, may
    put the patient at a significant risk, may confound study results, or may interfere
    significantly with the patient’s participation in the study.
    E.5 End points
    E.5.1Primary end point(s)
    Reports of one or more treatment-related adverse events associated with the ocular surface
    will be the primary variable. The proportion of patients reporting treatment-related ocular
    surface adverse events over the 2-year course of the study in each treatment group will be
    calculated.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    - same IMP used at different dosage
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last patient last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 724
    F.4.2.2In the whole clinical trial 784
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-05-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-03-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-12-06
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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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