Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

A Phase 3 Prospective, Randomized, Double-Masked, 12-Week, Parallel Group Study In Pediatric Subjects With Glaucoma.

1 febbraio 2021 aggiornato da: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

A Phase 3 Prospective, Randomized, Double-Masked, 12-Week, Parallel Group Study Evaluating The Efficacy And Safety Of Latanoprost And Timolol In Pediatric Subjects With Glaucoma.

To assess the effectiveness of latanoprost 0.005% ophthalmic solution dosed once-daily and timolol 0.5% dosed twice-daily in paediatric subjects of 18 years of age or under who are diagnosed with glaucoma.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

139

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Belgio
      • Leuven, Belgio, 3000
        • Pfizer Investigational Site
  • Cechia
      • Praha 5, Cechia, 150 06
        • Pfizer Investigational Site
  • Colombia
    • Antioquia
      • Medellín, Antioquia, Colombia, 0000
        • Pfizer Investigational Site
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia, 0000
        • Pfizer Investigational Site
  • Federazione Russa
      • Moscow, Federazione Russa, 119331
        • Pfizer Investigational Site
      • St. Petersburg, Federazione Russa, 194100
        • Pfizer Investigational Site
  • Filippine
      • Makati City, Filippine, 1200
        • Pfizer Investigational Site
      • Mandaluyong City, Filippine, 1500
        • Pfizer Investigational Site
  • Francia
      • Lille Cedex, Francia, 59037
        • Pfizer Investigational Site
      • Lyon, Francia, 69437
        • Pfizer Investigational Site
    • Cedex 1
      • Amiens, Cedex 1, Francia, 80054
        • Pfizer Investigational Site
  • Germania
      • Regenstauf, Germania, 93128
        • Pfizer Investigational Site
      • Schorndorf, Germania, 73614
        • Pfizer Investigational Site
  • India
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500034
        • Pfizer Investigational Site
    • Gujarat
      • Ahmedabad, Gujarat, India, 380004
        • Pfizer Investigational Site
    • Tamilnadu
      • Coimbatore, Tamilnadu, India, 641 014
        • Pfizer Investigational Site
  • Italia
      • Catania, Italia, 95123
        • Pfizer Investigational Site
      • Milano, Italia, 20162
        • Pfizer Investigational Site
  • Polonia
      • Bialystok, Polonia, 15-274
        • Pfizer Investigational Site
      • Gdansk, Polonia, 80-211
        • Pfizer Investigational Site
      • Wroclaw, Polonia, 50-368
        • Pfizer Investigational Site
  • Portogallo
      • Coimbra, Portogallo, 3000-548
        • Pfizer Investigational Site
      • Lisboa, Portogallo, 1649-035
        • Pfizer Investigational Site
      • Lisboa, Portogallo, 1169-019
        • Pfizer Investigational Site
      • Lisboa, Portogallo, 1169-097
        • Pfizer Investigational Site
      • Porto, Portogallo, 4099-001
        • Pfizer Investigational Site
  • Regno Unito
      • Birmingham, Regno Unito, B18 7QH
        • Pfizer Investigational Site
      • London, Regno Unito, EC1V 2PD
        • Pfizer Investigational Site
  • Romania
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400006
        • Pfizer Investigational Site
  • Serbia
      • Belgrade, Serbia, 11000
        • Pfizer Investigational Site
  • Slovacchia
      • Bratislava, Slovacchia, 83340
        • Pfizer Investigational Site
  • Slovenia
      • Ljubljana, Slovenia, 1000
        • Pfizer Investigational Site
  • Spagna
      • Madrid, Spagna, 28040
        • Pfizer Investigational Site
      • Sevilla, Spagna, 41013
        • Pfizer Investigational Site
    • Barcelona
      • Esplugues de Llobregat, Barcelona, Spagna, 08950
        • Pfizer Investigational Site
  • Stati Uniti
    • Florida
      • Pembroke Pines, Florida, Stati Uniti, 33028
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, Stati Uniti, 30322
        • Pfizer Investigational Site
    • Indiana
      • Indianapolis, Indiana, Stati Uniti, 46202
        • Pfizer Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, Stati Uniti, 55455
        • Pfizer Investigational Site
    • Nevada
      • Henderson, Nevada, Stati Uniti, 89052
        • Pfizer Investigational Site
      • Henderson, Nevada, Stati Uniti, 89074
        • Pfizer Investigational Site
      • Las Vegas, Nevada, Stati Uniti, 89148
        • Pfizer Investigational Site
  • Sud Africa
      • Myfair West, Sud Africa, 2109
        • Pfizer Investigational Site
  • Ucraina
      • Kharkiv, Ucraina, 61000
        • Pfizer Investigational Site
      • Kyiv, Ucraina
        • Pfizer Investigational Site
      • Kyiv, Ucraina, 04050
        • Pfizer Investigational Site
      • Kyiv, Ucraina, 01135
        • Pfizer Investigational Site
      • Odesa, Ucraina, 65061
        • Pfizer Investigational Site

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 8 mesi a 18 anni (Bambino, Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Male or female of 18 years of age or under
  • Diagnosis of glaucoma
  • IOP of 22 mmHg or above in at least 1 eye

Exclusion Criteria:

  • Require surgery for acute angle closure
  • Have had prior cyclodestructive procedures
  • Have a history of ocular trauma or surgery in either eye within 3 months of the baseline visit

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Timololo
Droga: Timolol
Timolol 0.5% dosed twice-daily
Sperimentale: latanoprost
Droga: latanoprost
Latanoprost 0.005% ophthalmic solution dosed once-daily

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Reduction From Baseline in Mean IOP at Week 12, Last Observation Carried Forward (LOCF)
Lasso di tempo: Baseline, Week 12
Calculated as Baseline IOP minus Week 12 IOP, LOCF. IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were less than or equal to (≤) 2 millimeters of mercury (mmHg) of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.
Baseline, Week 12

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Reduction From Baseline in Mean IOP at Week 1
Lasso di tempo: Baseline, Week 1
Calculated as Baseline IOP minus Week 1 IOP (observed). IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.
Baseline, Week 1
Reduction From Baseline in Mean IOP at Week 4
Lasso di tempo: Baseline, Week 4
Calculated as Baseline IOP minus Week 4 IOP (observed). IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.
Baseline, Week 4
Reduction From Baseline in Mean IOP at Week 12 (Observed)
Lasso di tempo: Baseline, Week 12
Calculated as Baseline IOP minus Week 12 IOP (observed). IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.
Baseline, Week 12
Mean IOP at Baseline
Lasso di tempo: Baseline
IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.
Baseline
Mean IOP at Week 1
Lasso di tempo: Week 1
IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.
Week 1
Mean IOP at Week 4
Lasso di tempo: Week 4
IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.
Week 4
Mean IOP at Week 12
Lasso di tempo: Week 12
IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.
Week 12
Percentage of Participants With Greater Than or Equal to (≥) 15% IOP Reduction From Baseline at Both Weeks 4 and 12
Lasso di tempo: Baseline, Week 4, and Week 12
Participants with ≥15% IOP reduction from baseline at both Week 4 and Week 12. Calculated as (post baseline IOP minus baseline IOP) divided by IOP, multiplied by 100%. IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.
Baseline, Week 4, and Week 12
Percentage of Participants Discontinuing Therapy Due to a Drug-related Adverse Experience
Lasso di tempo: Baseline through Week 12
An investigator's causality assessment was the determination of whether there existed a reasonable possibility that the investigational product caused or contributed to an adverse event (AE). If the investigator did not know whether or not investigational product caused the event, then the event was handled as "related to investigational product" for reporting purposes.
Baseline through Week 12

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 luglio 2008

Completamento primario (Effettivo)

1 novembre 2009

Completamento dello studio (Effettivo)

1 novembre 2009

Date di iscrizione allo studio

Primo inviato

14 luglio 2008

Primo inviato che soddisfa i criteri di controllo qualità

14 luglio 2008

Primo Inserito (Stima)

16 luglio 2008

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

3 febbraio 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 febbraio 2021

Ultimo verificato

1 gennaio 2011

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • A6111137

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Sottoscrivi