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

1. februar 2021 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

139

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Belgia
      • Leuven, Belgia, 3000
        • Pfizer Investigational Site
  • Colombia
    • Antioquia
      • Medellín, Antioquia, Colombia, 0000
        • Pfizer Investigational Site
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia, 0000
        • Pfizer Investigational Site
  • Den russiske føderasjonen
      • Moscow, Den russiske føderasjonen, 119331
        • Pfizer Investigational Site
      • St. Petersburg, Den russiske føderasjonen, 194100
        • Pfizer Investigational Site
  • Filippinene
      • Makati City, Filippinene, 1200
        • Pfizer Investigational Site
      • Mandaluyong City, Filippinene, 1500
        • Pfizer Investigational Site
  • Forente stater
    • Florida
      • Pembroke Pines, Florida, Forente stater, 33028
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, Forente stater, 30322
        • Pfizer Investigational Site
    • Indiana
      • Indianapolis, Indiana, Forente stater, 46202
        • Pfizer Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, Forente stater, 55455
        • Pfizer Investigational Site
    • Nevada
      • Henderson, Nevada, Forente stater, 89052
        • Pfizer Investigational Site
      • Henderson, Nevada, Forente stater, 89074
        • Pfizer Investigational Site
      • Las Vegas, Nevada, Forente stater, 89148
        • Pfizer Investigational Site
  • Frankrike
      • Lille Cedex, Frankrike, 59037
        • Pfizer Investigational Site
      • Lyon, Frankrike, 69437
        • Pfizer Investigational Site
    • Cedex 1
      • Amiens, Cedex 1, Frankrike, 80054
        • 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
  • 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
  • Romania
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400006
        • Pfizer Investigational Site
  • Serbia
      • Belgrade, Serbia, 11000
        • Pfizer Investigational Site
  • Slovakia
      • Bratislava, Slovakia, 83340
        • Pfizer Investigational Site
  • Slovenia
      • Ljubljana, Slovenia, 1000
        • Pfizer Investigational Site
  • Spania
      • Madrid, Spania, 28040
        • Pfizer Investigational Site
      • Sevilla, Spania, 41013
        • Pfizer Investigational Site
    • Barcelona
      • Esplugues de Llobregat, Barcelona, Spania, 08950
        • Pfizer Investigational Site
  • Storbritannia
      • Birmingham, Storbritannia, B18 7QH
        • Pfizer Investigational Site
      • London, Storbritannia, EC1V 2PD
        • Pfizer Investigational Site
  • Sør-Afrika
      • Myfair West, Sør-Afrika, 2109
        • Pfizer Investigational Site
  • Tsjekkia
      • Praha 5, Tsjekkia, 150 06
        • Pfizer Investigational Site
  • Tyskland
      • Regenstauf, Tyskland, 93128
        • Pfizer Investigational Site
      • Schorndorf, Tyskland, 73614
        • Pfizer Investigational Site
  • Ukraina
      • Kharkiv, Ukraina, 61000
        • Pfizer Investigational Site
      • Kyiv, Ukraina
        • Pfizer Investigational Site
      • Kyiv, Ukraina, 04050
        • Pfizer Investigational Site
      • Kyiv, Ukraina, 01135
        • Pfizer Investigational Site
      • Odesa, Ukraina, 65061
        • Pfizer Investigational Site

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

8 måneder til 18 år (Barn, Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Timolol
Legemiddel: Timolol
Timolol 0.5% dosed twice-daily
Eksperimentell: latanoprost
Legemiddel: latanoprost
Latanoprost 0.005% ophthalmic solution dosed once-daily

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juli 2008

Primær fullføring (Faktiske)

1. november 2009

Studiet fullført (Faktiske)

1. november 2009

Datoer for studieregistrering

Først innsendt

14. juli 2008

Først innsendt som oppfylte QC-kriteriene

14. juli 2008

Først lagt ut (Anslag)

16. juli 2008

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. februar 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. februar 2021

Sist bekreftet

1. januar 2011

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • A6111137

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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Legemiddelintervensjoner

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