A 12week, Randomized, Evaluator-Masked, Parallel Group Comparing Evening Dosing Of Xalacom Vs Cosopt In Subj W/ Glaucoma

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NCT00140049

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Study Location
Pfizer Investigational Site
Caen, , 14033, France
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

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[email protected]

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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

- Uni- or bilateral diagnosis of primary open angle glaucoma or ocular hypertension on beta-blocker monotherapy or dual therapy in which at least one medication is a beta-blocker for at least 4 weeks prior to screening

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


- Closed/ barely open anterior chamber angle or history of acute angle closure glaucoma.


- History of ALT (Argon Laser Trabeculoplasty) or SLT(selective Laser) within 3 months
prior to screening

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Advanced Information
Descriptive Information
Brief Title  ICMJE A 12week, Randomized, Evaluator-Masked, Parallel Group Comparing Evening Dosing Of Xalacom Vs Cosopt In Subj W/ Glaucoma
Official Title  ICMJE A 12-Week Randomized, Evaluator-Masked, Parallel-Group, Multinational, Multi-Center Study Comparing The Efficacy And Safety Of The Fixed Combination Of Latanoprost And Timolol (Xalacom) With The Fixed Combination Of Dorzolamide And Timolol (Cosopt) In Patients With Open-Angle Glaucoma Or Ocular Hypertension.
Brief Summary To demonstrate the statistical non inferiority of the combination of latanoprost and timolol given in the evening time once a day vs the combination of dorzamalide and timolol twice a day based on intraocular pressure measurements at 8 AM, 12 noon & 4 PM during a 12 week treatment.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Condition  ICMJE
  • Glaucoma, Open Angle
  • Ocular Hypertension
Intervention  ICMJE
  • Drug: Xalacom
  • Drug: Cosopt
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 Completed
Enrollment  ICMJE
 (submitted: August 30, 2005)		238
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Uni- or bilateral diagnosis of primary open angle glaucoma or ocular hypertension on beta-blocker monotherapy or dual therapy in which at least one medication is a beta-blocker for at least 4 weeks prior to screening

Exclusion Criteria:

  • Closed/ barely open anterior chamber angle or history of acute angle closure glaucoma.
  • History of ALT (Argon Laser Trabeculoplasty) or SLT(selective Laser) within 3 months prior to screening
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 France,   Germany,   Greece,   Italy,   Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00140049
Other Study ID Numbers  ICMJE A6641038
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date November 2007

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