Safety And Efficacy Of Xalatan Delivered Using Either A Conventional Dropper Bottle or A Delivery Device

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NCT00283764

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Open-Angle Glaucoma, Ocular Hypertension
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Diagnosis of primary open angle glaucoma or ocular hypertension in 1 or both eyes

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- History of closed/barely open anterior chamber angle or a history of angle closure

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Advanced Information
Descriptive Information
Brief Title  ICMJE Safety And Efficacy Of Xalatan Delivered Using Either A Conventional Dropper Bottle or A Delivery Device
Official Title  ICMJE A Phase 3, 12-Week, Parallel-Design Study Comparing The Safety, Efficacy, and Ease Of Use Of Xalatan When Self-Administered By Subjects With Open-Angle Glaucoma Or Ocular Hypertension Using Either A Conventional Dropper Bottle Or A Forced-Flow Delivery Device
Brief Summary Compare the antihypertensive efficacy of two methods for instilling Xalatan eyedrops
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Condition  ICMJE
  • Glaucoma, Open-Angle
  • Ocular Hypertension
Intervention  ICMJE Drug: Xalatan
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: March 4, 2015)		0
Original Enrollment  ICMJE
 (submitted: January 26, 2006)		712
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of primary open angle glaucoma or ocular hypertension in 1 or both eyes

Exclusion Criteria:

  • History of closed/barely open anterior chamber angle or a history of angle closure
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00283764
Other Study ID Numbers  ICMJE A6111086
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
Study Sponsor  ICMJE Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP