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    Summary
    EudraCT Number:2015-003631-34
    Sponsor's Protocol Code Number:192024-095
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-11-30
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2015-003631-34
    A.3Full title of the trial
    A Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients with Open-Angle Glaucoma or Ocular Hypertension
    Porovnání Bimatoprostu SR se selektivní laserovou trabekuloplastikou u pacientů s glaukomem s otevřeným úhlem nebo oční hypertenzí
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to compare a slow release formulation of bimatoprost with selective laser trabeculoplasty in patients with open-angle glaucoma or high pressure in the eye
    A.4.1Sponsor's protocol code number192024-095
    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 Ltd.
    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, Buckinghamshire
    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-ctrg@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 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 SR
    D.3.4Pharmaceutical form Implant
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntracameral 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.3.9.4EV Substance CodeSUB12470MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Open-angle glaucoma (OAG) or Ocular hypertension (OHT)
    E.1.1.1Medical condition in easily understood language
    Glaucoma and increased pressure inside the eye (ocular hypertension)
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLGT
    E.1.2Classification code 10018307
    E.1.2Term Glaucoma and ocular hypertension
    E.1.2System Organ Class 100000004853
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10030348
    E.1.2Term 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 evaluate the IOP-lowering effect and safety of Bimatoprost SR compared with SLT in patients with OAG or OHT, who are not adequately managed with topical IOP-lowering medication for reasons other than medication efficacy (e.g., due to intolerance or nonadherence).
    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, 18 years of age or older;
    2. Written informed consent and authorization for use and release of personal health information are obtained in accordance with the relevant country and local privacy requirements, where applicable (e.g., Written Authorization for Use and Release of Health and Research Study Information [United States (US) sites] and written Data Protection consent [European Union (EU) sites])
    3. Patient is willing to withhold his/her IOP treatments according to the study requirements, and in the opinion of the investigator, can do so without significant risk. Note: If patients cannot discontinue their currently prescribed therapy for up to 6 weeks to meet the Washout period for study entry., the investigator may switch the patient's medication to one that requires a shorter washout interval during the washout of the original medication (see Section 8.2 and Table 6 in the protocol)
    4. Patient has the ability to understand and the willingness to follow study instructions and requirements and is likely to complete all required visits and procedures
    5. In the investigator’s opinion, patient’s IOP is not adequately managed with topical medication for reasons other than medication efficacy (e.g., due to intolerance or nonadherence)
    6. Negative pregnancy test at Baseline for females of childbearing potential

    Both Eyes
    7. In the investigator’s opinion, both eyes can be treated adequately with topical prostamide, prostaglandin, or prostaglandin analog (e.g., LUMIGAN, Xalatan®, Travatan®) eye drops as the sole therapy if medication was taken as directed;
    8. In the investigator’s opinion, patient’s IOP can be adequately managed with SLT monotherapy
    9. In the investigator’s opinion, patient is a suitable candidate for SLT
    10. Diagnosis of either OAG (i.e., primary OAG, pseudoexfoliation glaucoma, pigmentary glaucoma) or OHT in each eye, requiring bilateral IOP-lowering treatment (Note: diagnosis does not have to be the same in both eyes);
    11. Central endothelial cell density by specular microscopy confirmed as being qualified by Reading Center assessment prior to beginning Washout
    12. The iridocorneal angle must be independently confirmed as being qualified by 2 ophthalmologists using the following critetia: a. Shaffer Grade ≥ 3 on clinical gonioscopy of the inferior angle b. Peripheral anterior chamber depth by Van Herick examination ≥ 1/2 corneal thickness. Note: The independent eligibility assessments must both agree that the Shaffer grade is ≥ 3 and the Van Herick grade is ≥ 1/2 corneal thickness
    13. At the Baseline visit, patient has been appropriately washed out of all IOP-lowering medications
    14. At the Baseline visit (8:00 AM ± 1 hour), IOP of ≥ 22 and ≤ 34 mm Hg, with difference between eyes of ≤ 5 mm Hg.
    15. At the Screening and Baseline (Day -3 to -1) visits, Best-Corrected Visual Acuity (Snellen equivalent, by manifest refraction) of 20/50 or better in each eye.
    E.4Principal exclusion criteria
    1. Uncontrolled systemic disease
    2. Females who are pregnant, nursing, or planning a pregnancy, or who are of childbearing potential and not using a reliable means of contraception during the study (see Section 4.5.3 of the protocol)
    3. Known allergy or sensitivity to the study medication or its components, any component of the delivery vehicle, or any diagnostic or surgical prep agents used during the study (eg, topical anesthetic, dilating drops, fluorescein, povidone-iodine)
    4. Any condition which would preclude the patient's ability to comply with study requirements (including completion of the study)
    5. Patients who have a condition or are in a situation, which, 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
    6. Concurrent or anticipated enrollment in an investigational drug or device study or participation in such a study from 2 months prior to the Baseline visit through the final study visit
    7. Previous or concurrent enrollment in another Allergan Bimatoprost SR
    study
    8. Known history of bleeding disorder or prolonged bleeding after surgery (in the opinion of the investigator). Note: Patients receiving pharmacologic blood thinners (eg, aspirin, Coumadin) may be enrolled at
    the investigator's discretion.

    Ocular Exclusion Criteria for Both Eyes:
    9. History of previous laser trabeculoplasty
    10. History or evidence of clinically relevant, substantial ocular trauma (eg, a traumatic cataract, traumatic angle recession, etc)
    11. The following surgical history:
    a. History or evidence of complicated cataract surgery: eg, surgery resulting in complicated lens placement (such as anterior chamber
    intraocular lens implant [IOL], sulcus IOL, aphakia, etc) or intraoperative complications (such as a posterior capsular tear [with or
    without vitreous loss], substantial iris trauma, etc). Note: history of uncomplicated cataract surgery is not an exclusion. b. History of phakic IOL insertion for refractive error correction
    12. Intraocular surgery (including cataract surgery) and/or any ocular laser surgery within the 6 months prior to treatment (Day 1)
    13. Any history of corneal graft, including partial grafts (eg, Descemet's Stripping Endothelial Keratoplasty [DSEK], Descemet's Membrane Endothelial Keratoplasty [DMEK]); or incisional refractive surgery (eg, radial keratotomy), other than astigmatic keratotomy or limbal relaxing incisions
    14. Corneal or other ocular abnormalities that would preclude accurate readings with an applanation tonometer, anterior segment-optical coherence tomography, specular microscope, and/or a contact
    pachymeter, or could confound study results, eg, moderate to severe corneal dystrophy, including Anterior Basement Membrane Disease (ABMD; ie, Map-Dot-Fingerprint [MDF]) and guttata. Mild ABMD or mild
    guttata are not exclusionary by clinical examination if, in the opinion of the investigator, the condition is stable and not likely to cause corneal changes during the
    course of the study.
    15. Active or recurrent ocular disease (eg, uveitis, ocular infection, chronic moderate to severe blepharitis or severe dry eye, severe ocular seasonal allergies) or sight threatening diseases (eg, neovascular agerelated
    macular degeneration [ARMD], diabetic macular edema) that, in the opinion of the investigator, would put the patient at a significant risk or would interfere with the interpretation of the study data. Patients
    with slowly progressive eye diseases (ie, mild cataracts, nonneovascular ARMD) can be enrolled at the discretion of the investigator.
    16. Any history of external ocular or intraocular malignancy, and/or any history of benign ocular neoplasia that in the investigator's opinion resulted in clinically significant ocular morbidity
    17. History of herpetic ocular diseases (including herpes simplex virus and varicella zoster virus)
    18. The following ocular surface findings:
    a. Bulbar conjunctival hyperemia, on either macroscopic or slit-lamp examination, > +1 (mild) at baseline b. Active ocular surface findings other than bulbar conjunctival
    hyperemia, on either macroscopic or slit-lamp examination, > +1 (mild) at Baseline
    19. History of moderate or worse (≥ +2) bulbar conjunctival hyperemia due to marketed prostaglandin, prostamide, or prostaglandin analog use

    For Exclusion criteria 20 to 30 please see protocol

    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable is IOP change from baseline and the primary time period is 24 weeks
    E.5.1.1Timepoint(s) of evaluation of this end point
    Weeks 4, 12, and 24
    E.5.2Secondary end point(s)
    Secondary efficacy variables to compare Bimatoprost SR eyes and SLT eyes include:
    1) IOP change from baseline time-weighted average through Week 24
    2) IOP changes from baseline at Weeks 8, 15, and 20
    3) Raw IOP at each visit
    4) Time to onset of effect (time to first achieving ≥ 20% IOP reduction)
    5) Time to initial use of nonstudy IOP-lowering treatment (as determined by the investigator)
    6) Percentage of Bimatoprost SR and SLT eyes achieving ≥ 20% reduction by visit
    E.5.2.1Timepoint(s) of evaluation of this end point
    1), 5) - Study duration
    2) - Weeks 8, 15, and 20
    3), 6) - Each visit
    4) - Time to first achieving ≥ 20% IOP reduction
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Paired eye, masked
    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
    360° SLT
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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
    Italy
    Poland
    Russian Federation
    Singapore
    Spain
    Thailand
    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
    The End of trial is defined by the last patient last visit (LPLV).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days30
    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.1.2.1Number of subjects for this age range: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 49
    F.4.2.2In the whole clinical trial 160
    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)
    Subjects will return to their standard of care treatment as determined by their physician after completion of the trial
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-03-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-12-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-01-26
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