A Study Comparing Xalacom And Xalatan In Patients With Primary Open Angle Glaucoma (POAG) Or Ocular Hypertension (OH).

NCT00383019

Last updated date
Study Location
Pfizer Investigational Site
Ichinomiya, Aichi, 491-0837, Japan
Contact
1-800-718-1021

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

- Intraocular pressure is 18 mmHg or more at baseline after treatment with Xalatan for 4 weeks or more.

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


- History of no-response to timolol


- History of trabeculectomy


- History of other ocular surgery including ALT, SLT,and trabeculotomy within 6 months

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ALL GENDERS
18 Years+
years
MULTIPLE SITES
Primary Open Angle (POAG) Glaucoma, Ocular HypertensionA Study Comparing Xalacom And Xalatan In Patients With Primary Open Angle Glaucoma (POAG) Or Ocular Hypertension (OH).
NCT00383019
  1. Ichinomiya, Aichi
  2. Ichinomiya, Aichi
  3. Nagoya, Aichi
  4. Nagoya, Aichi
  5. Nagoya, Aichi
  6. Narashino, Chiba
  7. Sapporo, Hokkaido
  8. Sapporo, Hokkaido
  9. Sapporo, Hokkaido
  10. Sapporo, Hokkaido
  11. Koube, Hyogo
  12. Kanazawa, Ishikawa
  13. Fujisawa, Kanagawa
  14. Kamakura, Kanagawa
  15. Sagamihara, Kanagawa
  16. Yokohama, Kanagawa
  17. Sapporo, Kokkaido
  18. Uji, Kyoto
  19. Miyakonojo, Miyazaki
  20. Kumagaya, Saitama
  21. Tokorozawa, Saitama
  22. Fuji, Shizuoka
  23. Fuji, Shizuoka
  24. Mishima, Shizuoka
  25. Susono, Shizuoka
  26. Bunkyo-ku, Tokyo
  27. Chiyoda-ku, Tokyo
  28. Chiyoda, Tokyo
  29. Hachioji, Tokyo
  30. Hamura, Tokyo
  31. Katsushika-ku, Tokyo
  32. Kiyose, Tokyo
  33. Koto-ku, Tokyo
  34. Meguro-ku, Tokyo
  35. Meguro, Tokyo
  36. Musashino, Tokyo
  37. Musashino, Tokyo
  38. Ota-ku, Tokyo
  39. Setagaya, Tokyo
  40. Shinjuku, Tokyo
  41. Tachikawa, Tokyo
  42. Taito-ku, Tokyo
  43. Fujuoka,
  44. Fukuoka,
  45. Fukuoka,
  46. Fukuoka,
  47. Gifu,
  48. Hiroshima,
  49. Niigata,
  50. Osaka,
  51. Osaka,
  52. Osaka,
  53. Shizuoka,
  54. Sugita,
ALL GENDERS
20 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study Comparing Xalacom And Xalatan In Patients With Primary Open Angle Glaucoma (POAG) Or Ocular Hypertension (OH).
Official Title  ICMJE A 8-Week, Randomized, Double-Masked, Parallel Group, Phase III Study Comparing The Efficacy And Safety Of Xalacom And Xalatan In Patients With Primary Open Angle Glaucoma (POAG) Or Ocular Hypertension (OH).
Brief Summary This study will examine the efficacy and safety of Xalacom comparing with those of Xalatan in Japanese patients with POAG or OH.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Glaucoma, Primary Open Angle (POAG)
  • Ocular Hypertension
Intervention  ICMJE
  • Drug: Xalacom (KP2035)
  • 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 Completed
Actual Enrollment  ICMJE
 (submitted: April 2, 2009)
289
Original Enrollment  ICMJE
 (submitted: September 29, 2006)
292
Actual Study Completion Date  ICMJE October 2007
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Intraocular pressure is 18 mmHg or more at baseline after treatment with Xalatan for 4 weeks or more.

Exclusion Criteria:

  • History of no-response to timolol
  • History of trabeculectomy
  • History of other ocular surgery including ALT, SLT,and trabeculotomy within 6 months
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 20 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 Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00383019
Other Study ID Numbers  ICMJE A6641050
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date August 2009

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