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    Summary
    EudraCT Number:2010-021507-24
    Sponsor's Protocol Code Number:192024-050
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-09-13
    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 ConcernedGermany - BfArM
    A.2EudraCT number2010-021507-24
    A.3Full title of the trial
    A Multicenter, Double-masked, Randomized, Parallel Study of the Safety and Efficacy of Bimatoprost 0.03%/Timolol 0.5% Preservative freeOphthalmic Solution Compared with GANFORT® (bimatoprost 0.03%/timolol 0.5% ophthalmic solution) Once Daily for 12 Weeks in Patients with Glaucoma or Ocular Hypertension
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical Study of the safety and efficacy of Bimotoprost 0.03%/Timolol 0.5% Preservative-free Ophthalmic Solution compared with GANFORT®(Bimotoprost 0.03%/Timolol 0.5% Ophthalmic Solution) once daily for 12 weeks in Patients with Glaucoma or Ocular Hypertension.
    A.4.1Sponsor's protocol code number192024-050
    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 Regualtory 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.co
    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 No
    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 nameBimatoprost 0.03%/Timolol 0.5% PF Ophthalmic Solution
    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.3.9.2Current sponsor codeAGN-192024
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTIMOLOL
    D.3.9.1CAS number 26839-75-8
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 GANFORT®
    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.3.4Pharmaceutical 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.3.9.2Current sponsor codeAGN-192024
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTIMOLOL
    D.3.9.1CAS number 26839-75-8
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    Glaucoma or Ocular Hypertension
    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 14.0
    E.1.2Level LLT
    E.1.2Classification code 10008833
    E.1.2Term Chronic angle-closure glaucoma
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level HLGT
    E.1.2Classification code 10018307
    E.1.2Term Glaucoma and ocular hypertension
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10009034
    E.1.2Term Chronic open angle 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 compare the efficacy and safety of bimatoprost 0.03%/ timolol 0.5% PF ophthalmic solution with GANFORT once-daily use for 12 weeks in patients with glaucoma or ocular hypertension (OHT).
    To show that bimatoprost 0.03%/timolol 0.5% PF ophthalmic solution has an acceptable safety profile.
    E.2.2Secondary objectives of the trial
    -
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female, 18 years of age or older and with legal age of consent.
    2. Written informed consent has been obtained.
    3. Written data protection consent has been obtained.
    4. Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable.
    5. Good general health, as determined by the investigator from medical history, physical examination finding, fasting blood analysis (hematology, blood chemistry), and urinalysis, that are within reference range or acceptable to the investigator. Patients may have laboratory tests repeated once for re-screening at the discretion of the investigator.
    6. Baseline: A negative urine pregnancy test result for females of childbearing potential. A female is considered to be of non-childbearing potential if she is postmenopausal (with no menses for 12 consecutive months) or without a uterus.
    7. Patient is able and willing to follow study instructions and likely to complete all required visits.
    8. Patient has ocular hypertension, chronic open-angle glaucoma, chronic-angle closure glaucoma with patent iridotomy/iridectomy, pseudoexfoliative glaucoma, or pigmentary glaucoma in both eyes.
    9. Patient can go without IOP-lowering therapy for 4 days to 4 weeks, without significant risk to the patient.
    10. Patient requires bilateral IOP-lowering therapy
    11. Hour 0 of screening: Patient has been on current medication for at least 1 month or is treatment naive.
    12. Hour 0 and hour 2 of screening: Approximately 12 to 14 hours after the last installation of any current medication, patient had been on treatment considered to be ineffective (IOP > 18 mm Hg in at least 1 eye) for at least 1 month OR treatment naive (IOP > 24 mm Hg in at least 1 eye). Qualifying hour 0 and hour 2 IOPs must have been from the same eye.
    13. Hour 0 of baseline: best-corrected visual acuity (BCVA) score equivalent to a Snellen acuity of 20/100 or better in each eye, using a logarithmic visual acuity chart.
    14. Hour 0 of baseline: IOP of ≥ 22 mm Hg and ≤ 30 mm Hg in each eye and asymmetry of IOP not greater than 3 mm Hg between the eyes
    E.4Principal exclusion criteria
    1. Uncontrolled systemic disease.
    2. Female patients who are pregnant, nursing, or planning a pregnancy or who are of childbearing potential and not using a reliable means of contraception throughout the study.
    3. Clinically relevant low or high blood pressure or pulse rate for age as determined by the investigator.
    4. Patient has a condition or is in a situation that, in the investigator’s opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient’s participation in the study.
    5. Contraindications to beta-adrenoceptor antagonist therapy such as chronic obstructive pulmonary disease, bronchial asthma, sinus bradycardia, second and third degree atrioventricular block, overt cardiac failure or cardiogenic shock or uncontrolled congestive heart failure.
    6. Known allergy or contraindication to use of fluorescein.
    7. Known allergy or sensitivity to the study medications or their components.
    8. Intermittent use of oral, intramuscular, or intravenous corticosteroids within 21 days prior to baseline or anticipated use within 21 days prior to a follow-up study visit, or topical ophthalmic corticosteroids from 2 months prior to the screening visit through the final study visit.
    9. Current enrollment in an investigational drug or device study or participation in such a study at or past the screening visit, or within 30 days prior to the baseline/day -1 visit.
    10. Corneal or other ocular abnormalities that would preclude accurate readings with an applanation tonometer (eg, refractive surgery, corneal graft, moderate to severe endothelial corneal dystrophy).
    11. Contraindication to pupil dilation.
    12. Central corneal thickness of greater than 600 micrometers or less than 500 micrometers in either eye at screening.
    13. Introduction or anticipated alteration of existing chronic systemic medications (topical or injection) that may have a substantial effect on IOP (eg, systemic betablockers) from 2 months prior to screening visit through the final study visit.
    14. Active or recurrent ocular disease (eg, uveitis, ocular infection, chronic moderate to severe blepharitis or severe dry eye, ocular seasonal allergies) that would interfere with the interpretation of the study data in either eye. NOTE: patients with chronic mild blepharitis, cataract, age-related macular degeneration, or a background diabetic retinopathy can be enrolled at the discretion of the investigator.
    15. History (within 6 months prior to baseline) of any ocular anterior segment laser or other intraocular surgery in either eye.
    16. History or evidence of severe ocular trauma in either eye.
    17. History of ocular neoplasia, uveitis, or herpetic ocular diseases.
    18. Required chronic use of other ocular medications (post-screening visit) during the study. NOTE: occasional use of artificial tear products is allowed but not within
    24 hours prior to a scheduled visit.
    19. 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 baseline (day -1).
    20. In either eye, anticipated wearing of contact lenses during the study (use of soft lenses should be discontinued at least 24 hours prior to baseline, and use of rigid gas permeable or hard contact lenses should be discontinued at least 1 week prior to baseline).
    21. Patient’s IOP was previously uncontrolled on bimatoprost monotherapy.
    22. Hour 0 of baseline : Ocular surface findings (eg, hyperemia or irritation equal to +0.5 [trace] or greater) in either eye.
    E.5 End points
    E.5.1Primary end point(s)
    The IOP-lowering effect of bimatoprost 0.03%/timolol 0.5% PF
    ophthalmic solution is non inferior to GANFORT with respect to change from baseline (follow-up minus baseline) in worse eye IOP at each hour evaluated (hours 0, 2 and 8) at week 12 in the PP population.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Change from baseline (follow-up minus time-matched baseline) in worse
    eye IOP at each hour evaluated (hours 0, 2 and 8) at week 12.
    E.5.2Secondary end point(s)
    The IOP-lowering effect of bimatoprost 0.03%/timolol 0.5% PF
    ophthalmic solution is equivalent to GANFORT with respect to change
    from baseline (follow-up minus baseline) in worse eye IOP at each hour
    evaluated (hours 0, 2 and 8) at week 12. This will be assessed in the ITT
    population.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Change from baseline (follow up minus baseline) in worse eye IOP at
    each hour evaluated (hours 0, 2 and 8) at week 12.
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    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 concerned13
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA33
    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
    Australia
    Czech Republic
    Germany
    Hungary
    Israel
    Russian Federation
    Spain
    United Kingdom
    United States
    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 visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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 years1
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 350
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 state250
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 450
    F.4.2.2In the whole clinical trial 500
    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)
    Patients will return to their standard of care treatment as determined by their physician after completion of the study.
    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 Decision2011-02-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-02-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-02-20
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