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    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2010-023917-68
    Sponsor's Protocol Code Number:192024-054
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-03-30
    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 ConcernedBelgium - FPS Health-DGM
    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.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A 2 year study to compare the safety of Lumigan 0.1 mg/ml with Lumigan 0.3 mg/ml in patients with increased eye pressure or glaucoma
    A.3.2Name or abbreviated title of the trial where available
    LUMIGAN® 0.1 mg/mL compared with LUMIGAN® 0.3 mg/mL in patients with glaucoma or ocular hypertension
    A.4.1Sponsor's protocol code number192024-054
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAllergan Limited
    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 supportAllergan Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAllergan Limited
    B.5.2Functional name of contact pointAllergan Limited EU Regulatory Dept
    B.5.3 Address:
    B.5.3.1Street Address1st Floor Marlow International, The Parkway
    B.5.3.2Town/ cityMarlow, Bucks
    B.5.3.3Post codeSL7 1YL
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441628494444
    B.5.5Fax number+441628494449
    B.5.6E-mailml-eu_reg_affairs@allergan.com
    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 0.1mg/ml
    D.2.1.1.2Name of the Marketing Authorisation holderAllergan Pharmaceuticals Ireland
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.1Product nameNot Applicable
    D.3.2Product code Not Applicable
    D.3.4Pharmaceutical form Eye drops, solution
    D.3.4.1Specific paediatric formulation No
    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.3.9.1CAS number 155206-00-1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.1
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 0.3mg/ml
    D.2.1.1.2Name of the Marketing Authorisation holderAllergan Pharmaceuticals Ireland
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.1Product nameNot Applicable
    D.3.2Product code Not Applicable
    D.3.4Pharmaceutical form Eye drops, solution
    D.3.4.1Specific paediatric formulation No
    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.3.9.1CAS number 155206-00-1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.3
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 (OHT)
    E.1.1.1Medical condition in easily understood language
    Ocular hypertension (high pressure in the eye) or glaucoma (an eye disease in which ocular hypertension may cause vision loss).

    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10030043
    E.1.2Term Ocular hypertension
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10018304
    E.1.2Term Glaucoma
    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 (OHT)
    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, chronic open-angle glaucoma (with elevated IOP as judged by the investigator), 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], or staining) equal to mild or greater in either eye found on gross macroscopic hyperaemia or slit-lamp examination. Note: "Mild or greater" corresponds to a grade of at least +1 for all assessments of the ocular surface (see Attachment 12.1) except for the assessments of fluorescein
    staining of the cornea and lissamine green staining of the conjunctiva which use the Oxford Staining Scheme (Figure 2), where "mild or greater" corresponds to a grade of at least II (> 10 dots in any one of the three regions: cornea, nasal or temporal conjunctiva).
    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 that 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). (Note-Results of two reliable visual field (VF) examinations are required for assessment of eligibility prior to randomization [see Section 8.2.2]. Both VF examinations should use the protocol-required testing method [see Attachment 12.1])
    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 24 hours 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 that, 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 (Day1, Month 2, Month 6, Month 12, Month 18, Month 24) in each treatment group will be calculated.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Adverse events will be monitored throughout the study. Adverse events over the 2-year course of the study (Day1, Month 2, Month 6, Month 12, Month 18, Month 24) in each treatment group will be calculated.
    E.5.2Secondary end point(s)
    Reports of one or more treatment-related adverse events associated with the ocular surface excluding those with a MedDRA preferred term of “conjunctival hyperaemia” will be the secondary variable. The proportion of patients reporting these adverse events in each treatment group over the 2-year course of the study (Day1, Month 2, Month 6, Month 12, Month 18, Month 24) will be calculated.

    E.5.2.1Timepoint(s) of evaluation of this end point
    Adverse events will be monitored throughout the study. The proportion of patients reporting these adverse events in each treatment group over the 2-year course of the study (Day1, Month 2, Month 6, Month 12, Month 18, Month 24) 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 Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned2
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    Czech Republic
    France
    Germany
    Hungary
    Israel
    Italy
    Poland
    Spain
    United Kingdom
    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 years5
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months7
    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.1.1Number of subjects for this age range: 0
    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.1.2.1Number of subjects for this age range: 392
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 392
    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 state185
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 724
    F.4.2.2In the whole clinical trial 784
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    After trial has ended patients will return to their standard of care treatment.
    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 Decision2011-04-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-07-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-12-06
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