이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

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

2021년 2월 1일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

139

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 남아프리카
      • Myfair West, 남아프리카, 2109
        • Pfizer Investigational Site
  • 독일
      • Regenstauf, 독일, 93128
        • Pfizer Investigational Site
      • Schorndorf, 독일, 73614
        • Pfizer Investigational Site
  • 러시아 연방
      • Moscow, 러시아 연방, 119331
        • Pfizer Investigational Site
      • St. Petersburg, 러시아 연방, 194100
        • Pfizer Investigational Site
  • 루마니아
    • Cluj
      • Cluj-Napoca, Cluj, 루마니아, 400006
        • Pfizer Investigational Site
  • 미국
    • Florida
      • Pembroke Pines, Florida, 미국, 33028
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, 미국, 30322
        • Pfizer Investigational Site
    • Indiana
      • Indianapolis, Indiana, 미국, 46202
        • Pfizer Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, 미국, 55455
        • Pfizer Investigational Site
    • Nevada
      • Henderson, Nevada, 미국, 89052
        • Pfizer Investigational Site
      • Henderson, Nevada, 미국, 89074
        • Pfizer Investigational Site
      • Las Vegas, Nevada, 미국, 89148
        • Pfizer Investigational Site
  • 벨기에
      • Leuven, 벨기에, 3000
        • Pfizer Investigational Site
  • 세르비아
      • Belgrade, 세르비아, 11000
        • Pfizer Investigational Site
  • 스페인
      • Madrid, 스페인, 28040
        • Pfizer Investigational Site
      • Sevilla, 스페인, 41013
        • Pfizer Investigational Site
    • Barcelona
      • Esplugues de Llobregat, Barcelona, 스페인, 08950
        • Pfizer Investigational Site
  • 슬로바키아
      • Bratislava, 슬로바키아, 83340
        • Pfizer Investigational Site
  • 슬로베니아
      • Ljubljana, 슬로베니아, 1000
        • Pfizer Investigational Site
  • 영국
      • Birmingham, 영국, B18 7QH
        • Pfizer Investigational Site
      • London, 영국, EC1V 2PD
        • Pfizer Investigational Site
  • 우크라이나
      • Kharkiv, 우크라이나, 61000
        • Pfizer Investigational Site
      • Kyiv, 우크라이나
        • Pfizer Investigational Site
      • Kyiv, 우크라이나, 04050
        • Pfizer Investigational Site
      • Kyiv, 우크라이나, 01135
        • Pfizer Investigational Site
      • Odesa, 우크라이나, 65061
        • Pfizer Investigational Site
  • 이탈리아
      • Catania, 이탈리아, 95123
        • Pfizer Investigational Site
      • Milano, 이탈리아, 20162
        • Pfizer Investigational Site
  • 인도
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, 인도, 500034
        • Pfizer Investigational Site
    • Gujarat
      • Ahmedabad, Gujarat, 인도, 380004
        • Pfizer Investigational Site
    • Tamilnadu
      • Coimbatore, Tamilnadu, 인도, 641 014
        • Pfizer Investigational Site
  • 체코
      • Praha 5, 체코, 150 06
        • Pfizer Investigational Site
  • 콜롬비아
    • Antioquia
      • Medellín, Antioquia, 콜롬비아, 0000
        • Pfizer Investigational Site
    • Cundinamarca
      • Bogota, Cundinamarca, 콜롬비아, 0000
        • Pfizer Investigational Site
  • 포르투갈
      • Coimbra, 포르투갈, 3000-548
        • Pfizer Investigational Site
      • Lisboa, 포르투갈, 1649-035
        • Pfizer Investigational Site
      • Lisboa, 포르투갈, 1169-019
        • Pfizer Investigational Site
      • Lisboa, 포르투갈, 1169-097
        • Pfizer Investigational Site
      • Porto, 포르투갈, 4099-001
        • Pfizer Investigational Site
  • 폴란드
      • Bialystok, 폴란드, 15-274
        • Pfizer Investigational Site
      • Gdansk, 폴란드, 80-211
        • Pfizer Investigational Site
      • Wroclaw, 폴란드, 50-368
        • Pfizer Investigational Site
  • 프랑스
      • Lille Cedex, 프랑스, 59037
        • Pfizer Investigational Site
      • Lyon, 프랑스, 69437
        • Pfizer Investigational Site
    • Cedex 1
      • Amiens, Cedex 1, 프랑스, 80054
        • Pfizer Investigational Site
  • 필리핀 제도
      • Makati City, 필리핀 제도, 1200
        • Pfizer Investigational Site
      • Mandaluyong City, 필리핀 제도, 1500
        • Pfizer Investigational Site

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

8개월 (어린이, 성인)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: 티몰롤
의약품: Timolol
Timolol 0.5% dosed twice-daily
실험적: latanoprost
의약품: latanoprost
Latanoprost 0.005% ophthalmic solution dosed once-daily

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Reduction From Baseline in Mean IOP at Week 12, Last Observation Carried Forward (LOCF)
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Reduction From Baseline in Mean IOP at Week 1
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

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

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2008년 7월 1일

기본 완료 (실제)

2009년 11월 1일

연구 완료 (실제)

2009년 11월 1일

연구 등록 날짜

최초 제출

2008년 7월 14일

QC 기준을 충족하는 최초 제출

2008년 7월 14일

처음 게시됨 (추정)

2008년 7월 16일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2021년 2월 3일

QC 기준을 충족하는 마지막 업데이트 제출

2021년 2월 1일

마지막으로 확인됨

2011년 1월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • A6111137

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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