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    Summary
    EudraCT Number:2018-002574-52
    Sponsor's Protocol Code Number:1698-301-007
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-07-30
    Trial 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 number2018-002574-52
    A.3Full title of the trial
    A Phase 3b Study to Evaluate the Duration of Effect of Bimatoprost SR in Participants with Open-Angle Glaucoma or Ocular Hypertension
    Studio di fase 3b teso a valutare la durata dell’effetto di bimatoprost SR in partecipanti con 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 Phase 3b Study to Evaluate the Duration of Effect of Bimatoprost SR in Participants with Open-Angle Glaucoma or Ocular Hypertension
    Studio di fase 3b teso a valutare la durata dell’effetto di bimatoprost SR in partecipanti con glaucoma ad angolo aperto o ipertensione oculare
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code number1698-301-007
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03850782
    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 Sales LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAllergan Ltd.
    B.5.2Functional name of contact pointCTRG
    B.5.3 Address:
    B.5.3.1Street AddressGround Floor, Marlow International, Parkway
    B.5.3.2Town/ cityMarlow, Buckinghamshire
    B.5.3.3Post codeSL7 1YL
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number000000
    B.5.5Fax number000000
    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 Sustained Release (SR), Implant
    D.3.2Product code [AGN-192024]
    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.3.9.1CAS number 155206-00-1
    D.3.9.2Current sponsor codeAGN-192024
    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 number10
    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 Yes
    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 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 Sustained Release (SR), Implant
    D.3.2Product code [AGN-192024]
    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.3.9.1CAS number 155206-00-1
    D.3.9.2Current sponsor codeAGN-192024
    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 Yes
    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
    Open-Angle Glaucoma or Ocular Hypertension
    Glaucoma ad Angolo Aperto o Ipertensione Oculare
    E.1.1.1Medical condition in easily understood language
    Open-Angle Glaucoma or Ocular Hypertension
    Glaucoma ad Angolo Aperto o 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 LLT
    E.1.2Classification code 10030856
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the duration of IOP-lowering effect of Bimatoprost SR in participants with OAG or OHT who are not adequately managed with topical IOP-lowering medication for reasons other than medication
    efficacy (eg, due to intolerance or nonadherence).
    Per valutare la durata dell'effetto di riduzione della PIO di Bimatoprost SR nei partecipanti con OAG o OHT che non sono adeguatamente gestiti con farmaci topici per la riduzione della PIO per motivi diversi dall'efficacia del farmaco (ad esempio, a causa di intolleranza o non aderenza).
    E.2.2Secondary objectives of the trial
    To evaluate the duration of IOP-lowering effect of Bimatoprost SR in participants with OAG or OHT who are not adequately managed with topical IOP-lowering medication for reasons other than medication
    efficacy (eg, due to intolerance or nonadherence).
    Per valutare la durata dell'effetto di riduzione della PIO di Bimatoprost SR nei partecipanti con OAG o OHT che non sono adeguatamente gestiti con farmaci topici per la riduzione della PIO per motivi diversi dall'efficacia del farmaco (ad esempio, a causa di intolleranza o non aderenza).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Participant must be at least 18 years of age at the time of signing the informed consent;
    -Male or female;
    -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 (eg, Written Authorization for Use and Release of Health and Research Study Information [US sites] and written Data Protection consent [EU sites]);
    -Female participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow up period;
    -A female participant is eligible to participate if she is not pregnant (ie, has a negative urine pregnancy result at Baseline), not breastfeeding, and at least one of the following conditions applies:
    a. Not a WOCBP as defined in Appendix 7 of the protocol
    OR
    b. A WOCBP who agrees to follow the contraceptive guidance in Appendix 7 of the protocol during the study period
    - Participant 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 participants cannot discontinue their currently prescribed therapy for up to 6 weeks to meet the Washout period for study entry,
    the investigator may switch the participant's medication to one that requires a shorter washout interval during the washout of the original medication.
    - Participant has the ability to understand and willingness to follow study instructions and is likely to complete all required visits and procedures
    - In the investigator's opinion, participant's IOP is not adequately managed with topical medication for reasons other than medication efficacy (eg, due to intolerance or nonadherence)
    - Diagnosis of either OAG (ie, primary OAG, pseudoexfoliation glaucoma, pigmentary glaucoma) or OHT in the study eye, requiring IOP-lowering treatment;
    -In the investigator's opinion, the study eye can be treated adequately with topical prostamide, prostaglandin, or prostaglandin analog (eg, LUMIGAN, Xalatan, Travatan) eye drops as the sole therapy if medication was taken as directed;
    -The iridocorneal angle in the study eye must be, in the opinion of the investigator, able to safely receive at least 1 Bimatoprost SR implant using the following criteria:
    a. Shaffer Grade = 3 on clinical gonioscopy of the inferior angle
    b. Peripheral anterior chamber depth by Van Herick examination = ½ corneal thickness;
    -At the Baseline visit, participant has been appropriately washed out of all IOPlowering medications;
    -At the Baseline visit (9:00 AM ± 1 hour), IOP of = 22 and = 34 mm Hg in
    the study eye;
    -Central corneal endothelial cell density by specular microscopy deemed acceptable, in the opinion of the investigator (at Screening, a minimum endothelial cell density of 1800 cells/mm2 in the study eye by automated analysis);
    -At the Baseline visit: BCVA (Snellen equivalent, by manifest refraction) of 20/50 or better in the study eye and 20/100 or better in the fellow eye;
    -Il partecipante deve avere almeno 18 anni al momento della firma del consenso informato;
    -Maschio o femmina;
    -Consenso informato scritto e autorizzazione per l'uso e il rilascio delle informazioni sulla salute personale sono ottenute in conformità ai requisiti nazionali e locali in materia di privacy, ove applicabile (ad es. autorizzazione scritta per l'uso e il rilascio di informazioni sugli studi sulla salute e la ricerca [centri statunitensi] e consenso scritto sulla protezione dei dati [centri dell'UE]);
    -I partecipanti femminili disposti a minimizzare il rischio di indurre una gravidanza per la durata dello studio clinico e del periodo di follow-up;
    -Un partecipante di sesso femminile può partecipare se non è incinta (ovvero se ha un risultato di gravidanza nelle urine negativo al basale), non sta allattando e si applica almeno una delle seguenti condizioni:
    a. Non una WOCBP come definito nell'Appendice 7 del protocollo
    O
    b. Una WOCBP che accetta di seguire la guida contraccettiva in Appendice 7 del protocollo durante il periodo di studio
    - Il partecipante è disposto a rifiutare i suoi trattamenti IOP secondo i requisiti di studio, e secondo l'opinione dello sperimentatore, possono farlo senza rischi significativi. Nota: se i partecipanti non possono interrompere la loro terapia attualmente prescritta per un massimo di 6 settimane per soddisfare il periodo di Washout per l'ingresso nello studio, lo Sperimentatore può cambiare il farmaco del partecipante in uno di quelli che richiede un intervallo di lavaggio più breve rispetto al farmaco originale.
    - Il partecipante ha la capacità di comprendere e la volontà di seguire studiare le istruzioni ed è probabile che completi tutte le visite richieste e procedure
    - Secondo lo Sperimentatore, l'IOP del partecipante non è adeguatamente gestito con farmaci topici per motivi diversi dall'efficacia del farmaco (ad es. a causa di intolleranza o non aderenza)
    - Diagnosi di OAG (ovvero, OAG primario, glaucoma pseudoesfoliante, glaucoma pigmentario) o OHT nell'occhio dello studio, che richiede un trattamento per la riduzione della PIO;
    -Secondo lo Sperimentatore, l'occhio dello studio può essere trattato adeguatamente con prostamide topica, prostaglandina o analogo della prostaglandina (ad es. LUMIGAN, Xalatan, Travatan) collirio come unica terapia se il farmaco è stato preso in maniera diretta;
    -L'angolo iridocorneale nell'occhio dello studio deve essere, secondo l'opinione dello Sperimentatore, in grado di ricevere in sicurezza almeno 1 impianto Bimatoprost SR utilizzando i seguenti criteri:
    a. Shaffer Grado = 3 su gonioscopia clinica dell'angolo inferiore
    b. Profondità periferica della camera anteriore mediante esame Van Herick = ½ spessore corneale;
    - Alla visita di riferimento, il partecipante sono stati opportunamente eliminati tutti i farmaci IOP lowering;
    -Alla visita di riferimento (9:00 AM ± 1 ora), IOP di = 22 e = 34 mm Hg nell'occhio di studio;
    -Densità delle cellule endoteliali corneali centrali mediante microscopia speculare considerata
    accettabile, secondo lo Sperimentatore (allo Screening, una densità minima delle cellule endoteliali di 1800 cellule/mm2 nell'occhio dello studio dall'analisi automatizzata);
    - Alla visita di riferimento: BCVA (equivalente di Snellen, per rifrazione manifesta) di 20/50 o meglio nell'occhio dello studio e 20/100 o meglio nell'occhio compagno;
    E.4Principal exclusion criteria
    -Uncontrolled systemic disease;
    -Females who are pregnant, nursing, or planning a pregnancy during the study OR who are WOCBP and will not follow contraceptive guidance;
    -Known allergy or sensitivity to any study medication or its components, any component of the delivery vehicle, procedure-related materials, or diagnostic agents used during the study (eg, topical anesthetic, dilating drops, fluorescein, povidone-iodine);
    -Participants who have a condition or are in a situation which, in the investigator's opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with the
    participant's participation in the study;
    -Concurrent or anticipated enrollment in an investigational drug or device study or participation in such a study within 2 months prior to the Baseline visit through the final study visit;
    -Previous enrollment in another Allergan Bimatoprost SR study;
    -Known history of bleeding disorder or prolonged bleeding after surgery (in the opinion of the investigator) Note: Participants receiving pharmacologic blood thinners (eg, aspirin, Coumadin) may be enrolled at the investigator's discretion;
    -History of previous laser trabeculoplasty in the study eye;
    -History or evidence of clinically relevant, substantial ocular trauma (eg, a traumatic cataract, traumatic angle recession, etc.) in the study eye;
    -The following surgical history in the study eye:
    a. History or evidence of complicated cataract/lens 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;
    -Intraocular surgery (including cataract surgery) in the study eye within the 6 months prior to treatment administration (Cycle 1 Administration);
    -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 in the study eye;
    -Central corneal thickness of < 480 or > 620 micrometers at Baseline in the study eye;
    - Malattia sistemica non controllata
    - Donne gestanti, che allattano al seno o che pianificano una gravidanza durante lo studio OPPURE che sono in grado di procreare e che non useranno metodi contraccettivi
    - Allergia o sensibilità nota al farmaco in studio o ai suoi componenti, ai componenti del veicolo di erogazione, materiali correlati alla procedura o agenti diagnostici utilizzati durante lo studio (ad es., anestetico topico, gocce dilatanti, fluoresceina, iodio povidone)
    - Pazienti che presentano una condizione o si trovano in una situazione che, secondo il parere dello sperimentatore, può esporre a rischio significativo, può confondere i risultati dello studio o può interferire in modo significativo con la partecipazione del paziente allo studio
    - Arruolamento simultaneo o previsto in uno studio su un farmaco o dispositivo sperimentale o partecipazione a tale studio nei 2 mesi che precedono la visita basale e fino alla visita finale dello studio
    - Precedente arruolamento in un altro studio su Bimatoprost SR di Allergan
    - Anamnesi nota di disturbo emorragico o sanguinamento prolungato dopo intervento chirurgico (secondo il parere dello sperimentatore) Nota: i partecipanti che ricevono anticoagulanti farmacologici (ad es. aspirina, Coumadin) possono essere arruolati a discrezione dello sperimentatore.
    - Anamnesi di precedente laser trabeculoplastica nell’occhio in studio
    - Anamnesi o evidenza di traumi oculari sostanziali clinicamente rilevanti (ad es. cataratta traumatica, recessione d’angolo secondaria a trauma, ecc.) nell’occhio in studio
    - La seguente anamnesi chirurgica nell’occhio in studio:
    a. Storia o evidenza di procedura chirurgica per il trattamento di cataratta complicata/cristallino: ad es., procedura chirurgica con conseguenti complicanze nel posizionamento del cristallino (ad es. impianto di lente intraoculare [Intraocular Lens Implant, IOL] in camera anteriore, IOL nel solco, afachia, ecc.) o complicanze intraoperatorie (ad es. rottura della capsula posteriore [con o senza perdita di corpo vitreo], trauma sostanziale dell’iride, ecc.)
    Nota: storia di procedura chirurgica per il trattamento di cataratta non complicata non è un’esclusione.
    b. Storia di impianto di IOL fachica per correzione di errore di rifrazione
    - Procedura chirurgica intraoculare (compresa procedura chirurgica per il trattamento della cataratta) nell’occhio in studio nei 6 mesi precedenti la somministrazione del trattamento (somministrazione del ciclo 1)
    - Storia di innesto corneale, compresi innesti parziali [ad es., cheratoplastica endoteliale con stripping della membrana di Descemet (Descemet’s Stripping Endothelial Keratoplasty, DSEK), cheratoplastica endoteliale e membrana di Descemet (Descemet’s Membrane Endothelial Keratoplasty, DMEK)]; o chirurgia refrattiva incisionale (ad es., cheratotomia radiale), eccetto cheratotomia astigmatica o incisioni rilassanti limbari nell’occhio in studio
    - Spessore corneale centrale < 480 o > 620 micrometri al basale nell’occhio in studio
    E.5 End points
    E.5.1Primary end point(s)
    Duration of effect of Bimatoprost SR
    Durata dell'effetto di Bimatoprost SR
    E.5.1.1Timepoint(s) of evaluation of this end point
    At each study visit starting baseline
    Ad ogni visita di studio base di partenza
    E.5.2Secondary end point(s)
    Adverse events; visual fields; visual acuity; macroscopic bulbar conjunctival hyperemia; slit-lamp biomicroscopic assessments; dilated ophthalmoscopic assessments (including optic disc assessment); contact ultrasound pachymetry; gonioscopy; specular microscopy
    Eventi avversi; campi visivi; acuità visiva; iperemia congiuntivale bulbare macroscopica; valutazioni biomicroscopiche con lampada a fessura; valutazioni oftalmoscopiche con pupilla dilatata (compresa la valutazione del disco ottico); pachimetria a ultrasuoni a contatto; gonioscopia; microscopia speculare
    E.5.2.1Timepoint(s) of evaluation of this end point
    At each study visit
    Ad ogni visita di studio
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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
    È uno studio mascherato da dosare: i soggetti saranno randomizzati a ricevere 10 µg o 15 µg di IMP
    t is a masked to dose study: subjects will be randomized to receive either a 10 µg or 15 µg of IMP
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA51
    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
    South Africa
    United States
    Bulgaria
    Denmark
    France
    Germany
    Hungary
    Ireland
    Italy
    Poland
    Sweden
    United Kingdom
    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
    A participant is considered to have completed the study if he/she has completed all visits of the study to Month 30, or if the participant has early exited. Participants who receive nonstudy IOP-lowering treatment (rescue) in the Bimatoprost SR treated eye may early exit the study at least 12 months after the participant's last Bimatoprost SR administration, if there are no safety concerns in the opinion of the
    investigator. All other participants will exit at the Month 30/Study Exit visit.
    Si consid che un partecip abbia complet lo studio se ha complet tutte le visite dello studio al 30°m, o se il partecip è uscito anticipat. I partecip che ricevono un tratt per la riduz della PIO che non sia il tratt in st (salvataggio) nell'occhio trattato con Bimatoprost SR possono uscire anticipat dallo studio almeno 12m dopo l'ultima somminist di Bimatoprost SR del partecip, se non vi sono prob di sicur a parere del PI. Tutti gli altri partecip usciranno all'uscita del mese 30/studio visita.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    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 years6
    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.1.2.1Number of subjects for this age range: 150
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 81
    F.4.2.2In the whole clinical trial 300
    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)
    No interventions after the end of the study are planned; participants will be treated per SOC by their health care provider.
    Non sono previsti interventi dopo la fine dello studio; i partecipanti saranno trattati per SoC dal loro fornitore di assistenza sanitaria.
    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 Decision2020-03-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-07-21
    P. End of Trial
    P.End of Trial StatusOngoing
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