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    Summary
    EudraCT Number:2015-003631-34
    Sponsor's Protocol Code Number:192024-095
    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:2021-07-30
    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 ConcernedItaly - Italian Medicines Agency
    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
    Confronto tra bimatoprost SR e trabeculoplastica laser selettiva in pazienti affetti da glaucoma ad angolo aperto o ipertensione oculare
    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
    Uno studio per comparare la formulazione di bimatoprost a rilascio prolungato con trabeculoplastica laser selettivain pazienti affetti da glaucoma ad angolo aperto o ipertensione oculare
    A.3.2Name or abbreviated title of the trial where available
    A study to compare a slow release formulation of bimatoprost with selective laser trabeculoplasty in
    Uno studio per comparare la formulazione di bimatoprost a rilascio prolungato con trabeculoplastica
    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 number00441628494444
    B.5.5Fax number00441628494449
    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.3.2Product code [-]
    D.3.4Pharmaceutical form Implant
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntracorneal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBIMATOPROST
    D.3.9.2Current sponsor code--
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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
    D.8.3Pharmaceutical form of the placeboImplant
    D.8.4Route of administration of the placeboIntravitreal use
    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)
    glaucoma ad angolo aperto (OAG) o ipertensione oculare (OHT)
    E.1.1.1Medical condition in easily understood language
    Glaucoma and increased pressure inside the eye (ocular hypertension)
    Glaucoma e pressione aumentata all'interno dell'occhio (ipertensione oculare)
    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 PT
    E.1.2Classification code 10030348
    E.1.2Term Open angle glaucoma
    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 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 HLGT
    E.1.2Classification code 10018307
    E.1.2Term Glaucoma and ocular hypertension
    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).
    Valutare l'effetto di riduzione della pressione intraoculare (IOP) e la sicurezza di Bimatoprost SR rispetto alla trabeculoplastica laser selettiva (SLT) in pazienti affetti da glaucoma ad angolo aperto (OAG) o ipertensione oculare (OHT), non adeguatamente gestiti con farmaci antipertensivi oculari topici per motivi diversi dall'efficacia dei farmaci (per es. a causa di intolleranza o mancata aderenza).
    E.2.2Secondary objectives of the trial
    Not applicable
    Non applicabile
    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. 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)

    Ocular
    1. 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;
    2. In the investigator’s opinion, patient’s IOP can be adequately managed with SLT monotherapy;
    3. In the investigator’s opinion, patient is a suitable candidate for SLT;
    4. 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);
    5. Central endothelial cell density by specular microscopy confirmed as being qualified by Reading Center assessment prior to beginning Washout;
    6.The iridocorneal angle be independently confirmed as being qualified by 2 ophthalmologists using the following criteria:
    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.
    7. At the Baseline visit (8:00 AM ± 1 hour), IOP of = 22 and = 34 mm Hg, with difference between eyes of = 5 mm Hg.
    1. Pazienti di entrambi i sessi, di età pari o superiore a 18 anni.
    2. Dove applicabile, il consenso informato scritto e l'autorizzazione all'uso e alla divulgazione delle informazioni sanitarie personali devono essere ottenuti in conformità ai requisiti nazionali e locali vigenti in materia di privacy (per es. autorizzazione scritta all'uso e alla divulgazione delle informazioni sanitarie e dello studio di ricerca per i centri negli Stati Uniti [USA] e consenso scritto al trattamento dei dati per i centri nell'Unione Europea [UE])
    3. Secondo il parere dello sperimentatore, la IOP del paziente non è adeguatamente gestita con farmaci topici per motivi diversi dall'efficacia dei farmaci (per es. a causa di intolleranza o mancata aderenza).

    Oculare:
    1. Secondo il parere dello sperimentatore, entrambi gli occhi possono essere trattati adeguatamente con collirio topico contenente prostamide,prostaglandina o analogo della prostaglandina (per es. LUMIGAN, Xalatan® , Travatan® ) come unica terapia se il farmaco viene utilizzato secondo le istruzioni ricevute
    2. Secondo il parere dello sperimentatore, la IOP del paziente può essere gestita adeguatamente con SLT in monoterapia.
    3 Secondo il parere dello sperimentatore, il paziente è un candidato idoneo alla SLT.
    4. Diagnosi di OAG (ovvero OAG primario, glaucoma pseudoesfoliativo, glaucoma pigmentario) o OHT in ciascun occhio e necessità di trattamento antipertensivo oculare in entrambi gli occhi (Nota: la diagnosi non deve essere necessariamente identica in entrambi gli occhi).
    5. La densità delle cellule endoteliali centrali misurata con microscopia speculare deve essere confermata come idonea con la valutazione eseguita dal centro di lettura prima dell'inizio del washout.
    6. L'angolo iridocorneale può essere confermato indipendentemente come qualificato da 2 oftalmologi che utilizzano i seguenti criteri:
    a. un grado di Shaffer = 3 sulla gonioscopia clinica dell'angolo inferiore
    b. Profondità della camera anteriore periferica mediante esame di Van Herick = 1/2 spessore corneale
    Nota: le valutazioni di ammissibilità indipendenti devono entrambe concordare sul fatto che il grado di Shaffer è = 3 e il grado di Van Herick è = 1/2 di spessore corneale.
    7. Alla visita iniziale (8:00 ± 1 ora), IOP = 22 e = 34 mm Hg, con una differenza tra gli occhi = 5 mm Hg.
    E.4Principal exclusion criteria
    Ocular
    1. History of previous laser trabeculoplasty

    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
    Oculare:
    1. Anamnesi della precedente laser trabeculoplastica

    La seguente storia chirurgica:

    a Anamnesi o evidenza di complicata chirurgia della cataratta: ad es. chirurgia risultante in un posizionamento complicato della lente (come la camera anteriore impianto di lenti intraoculari (IOL, solco IOL, afachia, ecc.) o complicazioni intraoperatorie (come una lacrima capsulare posteriore [con o senza perdita vitrea], trauma dell'iride sostanziale, ecc.). Nota: storia di una chirurgia della cataratta non complicata non è un'esclusione.
    b. Anamnesi dell'inserimento di IOL fachica per la correzione dell'errore di rifrazione
    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
    La variabile di efficacia primaria è la variazione della IOP rispetto alla visita iniziale e il periodo di tempo primario è di 24 settimane
    E.5.1.1Timepoint(s) of evaluation of this end point
    Weeks 4, 12, and 24
    Settimane 4, 12, e 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.
    La variabile di efficacia secondaria è di comparare Bimatoprost SR occhi e SLT occhi per includere: 1) variazione della IOP rispetto alla visita iniziale e il periodo di tempo primario è di 24 settimane 2) variazione della IOP rispetto alla visita iniziale alle Settimane 8, 15 e 20 3) IOP non elaborata per visita 4) tempo all'insorgenza dell'effetto (primo conseguimento di una riduzione della IOP = 20%) 5) tempo all'uso iniziale di un trattamento antipertensivo oculare non dello studio (come determinato dallo sperimentatore) 6) percentuale di occhi bimatoprost SR e SLT che ottengono una riduzione = 20% per visita
    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
    1), 5) - Durata dello studio 2) 8, 15, e 20 settimane 3), 6) - Ogni visita 4) Tempo dal primo raggiungimento = 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
    Analisi comparativa tra i due occhi, doppio cieco
    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
    SLT a 360°
    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 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 concerned7
    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 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
    Russian Federation
    Singapore
    Thailand
    United States
    Belgium
    Denmark
    France
    Italy
    Poland
    Spain
    Czechia
    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).
    La fine dello studio è definita con l'ultima visita dell'ultimo paziente (LPLV)
    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 months10
    E.8.9.1In the Member State concerned days7
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days7
    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 state42
    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
    I soggetti torneranno alla loro cura standard di trattamento , come determinato dal loro medico dopo il completamento dello studio clinico
    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 Decision2017-05-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-09-21
    P. End of Trial
    P.End of Trial StatusCompleted
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