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

1. februar 2021 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

139

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Belgien
      • Leuven, Belgien, 3000
        • Pfizer Investigational Site
  • Colombia
    • Antioquia
      • Medellín, Antioquia, Colombia, 0000
        • Pfizer Investigational Site
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia, 0000
        • Pfizer Investigational Site
  • Den Russiske Føderation
      • Moscow, Den Russiske Føderation, 119331
        • Pfizer Investigational Site
      • St. Petersburg, Den Russiske Føderation, 194100
        • Pfizer Investigational Site
  • Det Forenede Kongerige
      • Birmingham, Det Forenede Kongerige, B18 7QH
        • Pfizer Investigational Site
      • London, Det Forenede Kongerige, EC1V 2PD
        • Pfizer Investigational Site
  • Filippinerne
      • Makati City, Filippinerne, 1200
        • Pfizer Investigational Site
      • Mandaluyong City, Filippinerne, 1500
        • Pfizer Investigational Site
  • Forenede Stater
    • Florida
      • Pembroke Pines, Florida, Forenede Stater, 33028
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30322
        • Pfizer Investigational Site
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46202
        • Pfizer Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55455
        • Pfizer Investigational Site
    • Nevada
      • Henderson, Nevada, Forenede Stater, 89052
        • Pfizer Investigational Site
      • Henderson, Nevada, Forenede Stater, 89074
        • Pfizer Investigational Site
      • Las Vegas, Nevada, Forenede Stater, 89148
        • Pfizer Investigational Site
  • Frankrig
      • Lille Cedex, Frankrig, 59037
        • Pfizer Investigational Site
      • Lyon, Frankrig, 69437
        • Pfizer Investigational Site
    • Cedex 1
      • Amiens, Cedex 1, Frankrig, 80054
        • Pfizer Investigational Site
  • Indien
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, Indien, 500034
        • Pfizer Investigational Site
    • Gujarat
      • Ahmedabad, Gujarat, Indien, 380004
        • Pfizer Investigational Site
    • Tamilnadu
      • Coimbatore, Tamilnadu, Indien, 641 014
        • Pfizer Investigational Site
  • Italien
      • Catania, Italien, 95123
        • Pfizer Investigational Site
      • Milano, Italien, 20162
        • Pfizer Investigational Site
  • Polen
      • Bialystok, Polen, 15-274
        • Pfizer Investigational Site
      • Gdansk, Polen, 80-211
        • Pfizer Investigational Site
      • Wroclaw, Polen, 50-368
        • Pfizer Investigational Site
  • Portugal
      • Coimbra, Portugal, 3000-548
        • Pfizer Investigational Site
      • Lisboa, Portugal, 1649-035
        • Pfizer Investigational Site
      • Lisboa, Portugal, 1169-019
        • Pfizer Investigational Site
      • Lisboa, Portugal, 1169-097
        • Pfizer Investigational Site
      • Porto, Portugal, 4099-001
        • Pfizer Investigational Site
  • Rumænien
    • Cluj
      • Cluj-Napoca, Cluj, Rumænien, 400006
        • Pfizer Investigational Site
  • Serbien
      • Belgrade, Serbien, 11000
        • Pfizer Investigational Site
  • Slovakiet
      • Bratislava, Slovakiet, 83340
        • Pfizer Investigational Site
  • Slovenien
      • Ljubljana, Slovenien, 1000
        • Pfizer Investigational Site
  • Spanien
      • Madrid, Spanien, 28040
        • Pfizer Investigational Site
      • Sevilla, Spanien, 41013
        • Pfizer Investigational Site
    • Barcelona
      • Esplugues de Llobregat, Barcelona, Spanien, 08950
        • Pfizer Investigational Site
  • Sydafrika
      • Myfair West, Sydafrika, 2109
        • Pfizer Investigational Site
  • Tjekkiet
      • Praha 5, Tjekkiet, 150 06
        • Pfizer Investigational Site
  • Tyskland
      • Regenstauf, Tyskland, 93128
        • Pfizer Investigational Site
      • Schorndorf, Tyskland, 73614
        • 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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

8 måneder til 18 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Timolol
Medicin: Timolol
Timolol 0.5% dosed twice-daily
Eksperimentel: latanoprost
Medicin: latanoprost
Latanoprost 0.005% ophthalmic solution dosed once-daily

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Reduction From Baseline in Mean IOP at Week 12, Last Observation Carried Forward (LOCF)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Reduction From Baseline in Mean IOP at Week 1
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2008

Primær færdiggørelse (Faktiske)

1. november 2009

Studieafslutning (Faktiske)

1. november 2009

Datoer for studieregistrering

Først indsendt

14. juli 2008

Først indsendt, der opfyldte QC-kriterier

14. juli 2008

Først opslået (Skøn)

16. juli 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. februar 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. februar 2021

Sidst verificeret

1. januar 2011

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • A6111137

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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