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

1 février 2021 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

139

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Afrique du Sud
      • Myfair West, Afrique du Sud, 2109
        • Pfizer Investigational Site
  • Allemagne
      • Regenstauf, Allemagne, 93128
        • Pfizer Investigational Site
      • Schorndorf, Allemagne, 73614
        • Pfizer Investigational Site
  • Belgique
      • Leuven, Belgique, 3000
        • Pfizer Investigational Site
  • Colombie
    • Antioquia
      • Medellín, Antioquia, Colombie, 0000
        • Pfizer Investigational Site
    • Cundinamarca
      • Bogota, Cundinamarca, Colombie, 0000
        • Pfizer Investigational Site
  • Espagne
      • Madrid, Espagne, 28040
        • Pfizer Investigational Site
      • Sevilla, Espagne, 41013
        • Pfizer Investigational Site
    • Barcelona
      • Esplugues de Llobregat, Barcelona, Espagne, 08950
        • Pfizer Investigational Site
  • France
      • Lille Cedex, France, 59037
        • Pfizer Investigational Site
      • Lyon, France, 69437
        • Pfizer Investigational Site
    • Cedex 1
      • Amiens, Cedex 1, France, 80054
        • Pfizer Investigational Site
  • Fédération Russe
      • Moscow, Fédération Russe, 119331
        • Pfizer Investigational Site
      • St. Petersburg, Fédération Russe, 194100
        • Pfizer Investigational Site
  • Inde
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, Inde, 500034
        • Pfizer Investigational Site
    • Gujarat
      • Ahmedabad, Gujarat, Inde, 380004
        • Pfizer Investigational Site
    • Tamilnadu
      • Coimbatore, Tamilnadu, Inde, 641 014
        • Pfizer Investigational Site
  • Italie
      • Catania, Italie, 95123
        • Pfizer Investigational Site
      • Milano, Italie, 20162
        • Pfizer Investigational Site
  • Le Portugal
      • Coimbra, Le Portugal, 3000-548
        • Pfizer Investigational Site
      • Lisboa, Le Portugal, 1649-035
        • Pfizer Investigational Site
      • Lisboa, Le Portugal, 1169-019
        • Pfizer Investigational Site
      • Lisboa, Le Portugal, 1169-097
        • Pfizer Investigational Site
      • Porto, Le Portugal, 4099-001
        • Pfizer Investigational Site
  • Philippines
      • Makati City, Philippines, 1200
        • Pfizer Investigational Site
      • Mandaluyong City, Philippines, 1500
        • Pfizer Investigational Site
  • Pologne
      • Bialystok, Pologne, 15-274
        • Pfizer Investigational Site
      • Gdansk, Pologne, 80-211
        • Pfizer Investigational Site
      • Wroclaw, Pologne, 50-368
        • Pfizer Investigational Site
  • Roumanie
    • Cluj
      • Cluj-Napoca, Cluj, Roumanie, 400006
        • Pfizer Investigational Site
  • Royaume-Uni
      • Birmingham, Royaume-Uni, B18 7QH
        • Pfizer Investigational Site
      • London, Royaume-Uni, EC1V 2PD
        • Pfizer Investigational Site
  • Serbie
      • Belgrade, Serbie, 11000
        • Pfizer Investigational Site
  • Slovaquie
      • Bratislava, Slovaquie, 83340
        • Pfizer Investigational Site
  • Slovénie
      • Ljubljana, Slovénie, 1000
        • Pfizer Investigational Site
  • Tchéquie
      • Praha 5, Tchéquie, 150 06
        • Pfizer Investigational Site
  • Ukraine
      • Kharkiv, Ukraine, 61000
        • Pfizer Investigational Site
      • Kyiv, Ukraine
        • Pfizer Investigational Site
      • Kyiv, Ukraine, 04050
        • Pfizer Investigational Site
      • Kyiv, Ukraine, 01135
        • Pfizer Investigational Site
      • Odesa, Ukraine, 65061
        • Pfizer Investigational Site
  • États-Unis
    • Florida
      • Pembroke Pines, Florida, États-Unis, 33028
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, États-Unis, 30322
        • Pfizer Investigational Site
    • Indiana
      • Indianapolis, Indiana, États-Unis, 46202
        • Pfizer Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, États-Unis, 55455
        • Pfizer Investigational Site
    • Nevada
      • Henderson, Nevada, États-Unis, 89052
        • Pfizer Investigational Site
      • Henderson, Nevada, États-Unis, 89074
        • Pfizer Investigational Site
      • Las Vegas, Nevada, États-Unis, 89148
        • Pfizer Investigational Site

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

8 mois à 18 ans (Enfant, Adulte)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: Timolol
Médicament: Timolol
Timolol 0.5% dosed twice-daily
Expérimental: latanoprost
Médicament: latanoprost
Latanoprost 0.005% ophthalmic solution dosed once-daily

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Reduction From Baseline in Mean IOP at Week 12, Last Observation Carried Forward (LOCF)
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Reduction From Baseline in Mean IOP at Week 1
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

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

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 juillet 2008

Achèvement primaire (Réel)

1 novembre 2009

Achèvement de l'étude (Réel)

1 novembre 2009

Dates d'inscription aux études

Première soumission

14 juillet 2008

Première soumission répondant aux critères de contrôle qualité

14 juillet 2008

Première publication (Estimation)

16 juillet 2008

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

3 février 2021

Dernière mise à jour soumise répondant aux critères de contrôle qualité

1 février 2021

Dernière vérification

1 janvier 2011

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • A6111137

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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