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

Back to Search
Print
Bookmark Trial

NCT00140049

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Caen, , 14033, France
See other locations
Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

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

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

Call Now
pfizer-logoClinical Trials
Interested in learning more about clinical trials?
Discover how clinical trials work and the impact your participation could have.
Learn more ›

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Advanced Search

Based on your search, you may also be interested in

Open Angle Glaucoma, Ocular HypertensionA Study of Open Angle Glaucoma or Ocular Hypertension in Patients Within Scandinavia
NCT00751062
  1. Hellerup,
  2. Vejle,
  3. Oulu,
  4. Bergen,
  5. Oslo,
  6. Trondheim,
  7. Gothenburg,
  8. Huddinge,
  9. Linkoping,
  10. Lund,
  11. Malmo,
  12. Umea,
  13. Uppsala,
ALL GENDERS
40 Years+
years
MULTIPLE SITES
Open Angle Glaucoma, Ocular HypertensionA 12-week, Randomized, Double-masked, Parallel Group Comparison of Evening Dosing With Xalacom in Subjects With Glaucoma
NCT00277498
  1. Birmingham, Alabama
  2. Flagstaff, Arizona
  3. Artesia, California
  4. Los Angeles, California
  5. Newport Beach, California
  6. Sacramento, California
  7. San Francisco, California
  8. Colorado Springs, Colorado
  9. Gainesville, Florida
  10. Lecanto, Florida
  11. Miami, Florida
  12. Panama City, Florida
  13. Idaho Falls, Idaho
  14. Bourbonnais, Illinois
  15. Calumet City, Illinois
  16. Chicago, Illinois
  17. Chicago, Illinois
  18. Evansville, Indiana
  19. Madison, Indiana
  20. New Albany, Indiana
  21. Newburgh, Indiana
  22. Iowa City, Iowa
  23. Wichita, Kansas
  24. Louisville, Kentucky
  25. Bangor, Maine
  26. Reading, Massachusetts
  27. Ann Arbor, Michigan
  28. Detroit, Michigan
  29. Stillwater, Minnesota
  30. Creve Coeur, Missouri
  31. Kansas City, Missouri
  32. Warrensburg, Missouri
  33. Washington, Missouri
  34. Piscataway, New Jersey
  35. Princeton, New Jersey
  36. Brooklyn, New York
  37. New York, New York
  38. Rochester, New York
  39. Durham, North Carolina
  40. Durham, North Carolina
  41. Greensboro, North Carolina
  42. Winston-Salem, North Carolina
  43. Cleveland, Ohio
  44. Roseburg, Oregon
  45. Philadelphia, Pennsylvania
  46. Philadelphia, Pennsylvania
  47. Reading, Pennsylvania
  48. Wyomissing, Pennsylvania
  49. Charleston, South Carolina
  50. Charleston, South Carolina
  51. Maryville, Tennessee
  52. Austin, Texas
  53. Austin, Texas
  54. Dallas, Texas
  55. El Paso, Texas
  56. El Paso, Texas
  57. Fort Worth, Texas
  58. Houston, Texas
  59. Houston, Texas
  60. San Antonio, Texas
  61. San Antonio, Texas
  62. San Antonio, Texas
  63. Fredericksburg, Virginia
  64. Seattle, Washington
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Open Angle Glaucoma, Ocular HypertensionXalacom And Combination Of Unfixed Latanoprost And Timolol In Subjects With Open-Angle Glaucoma Or Ocular Hypertension
NCT00219596
  1. Beijing, Beijing
  2. Beijing, Beijing
  3. Guangzhou, Guangdong
  4. Shanghai, Shanghai
  5. Xi?an, Shanxi
  6. Hangzhou, Zhejiang
  7. Hangzhou, Zhejiang
  8. Shanghai,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Open Angle Glaucoma, Ocular HypertensionA 12week, Randomized, Evaluator-Masked, Parallel Group Comparing Evening Dosing Of Xalacom Vs Cosopt In Subj W/ Glaucoma
NCT00140049
  1. Caen,
  2. Clermont-ferrand,
  3. Lyon,
  4. Marseille Cedex 05,
  5. Saint Herblain,
  6. Darmstadt,
  7. Darmstadt,
  8. Landau / Pfalz,
  9. Regenstauf,
  10. Schorndorf,
  11. Starnberg,
  12. Heraklion, Crete
  13. Thessaloniki, Macedonia
  14. Alexandroupoli,
  15. Larisa,
  16. Chieti,
  17. Foggia,
  18. Genova,
  19. Milano,
  20. Monza (MI),
  21. Pisa,
  22. Malmo,
  23. Molndal,
  24. Sundsvall,
  25. örebro,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
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 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 November 2007

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