A Study of Glaucoma or Ocular Hypertension in Patients Within the United States

NCT00800267

Last updated date
Study Location
Pfizer Investigational Site
Anaheim, California, 92801, United States
Contact
1-800-718-1021

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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.
Ocular Hypertension, Glaucoma
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

- Unilateral or bilateral primary open angle glaucoma, capsular glaucoma, pigmentary glaucoma or ocular hypertension.

- Patients currently on IOP reducing therapy: IOP greater than or equal to 25mmHg (Ltwo IOP determinations at pre-study separated by at least one hour) OR Patients without IOP reducing therapy: IOP greater than or equal to 30mmHg (two IOP determinations at pre-study separated by at least one hour).

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


- History of acute angle closure or closed/barely open anterior chamber angle.


- Current use of contact lenses.


- Ocular surgery or argon laser trabeculoplasty (ALT) within three months prior to
pre-study visit.


- Ocular inflammation/infection occurring within three months prior to pre-study visit.


- Hypersensitivity to benzalkonium chloride or to any other component of the study drug
solutions.


- Other abnormal ocular condition or symptom preventing the patient from entering the
study, according to the investigator's judgement.


- Patients with conditions in which treatment with B-blocking agents are
contraindicated: cardiac failure, sinus bradycardia, second and third degree
atrio-ventricular block.


- Patients with conditions in which treatment with B-blocking agents are
contraindicated: bronchial asthma, history of bronchial asthma or chronic obstructive
pulmonary disease.


- Inability to adhere to treatment/visit plan.


- Have participated in any other clinical study within one month prior to pre-study
visit.

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Ocular Hypertension, GlaucomaA Study of Glaucoma or Ocular Hypertension in Patients Within the United States
NCT00800267
  1. Anaheim, California
  2. Anaheim, California
  3. Sacramento, California
  4. Sacramento, California
  5. San Francisco, California
  6. Boulder, Colorado
  7. Denver, Colorado
  8. Largo, Florida
  9. Tampa, Florida
  10. Atlanta, Georgia
  11. Atlanta, Georgia
  12. Atlanta, Georgia
  13. East Point, Georgia
  14. Griffin, Georgia
  15. Morrow, Georgia
  16. Chicago, Illinois
  17. Wheaton, Illinois
  18. Elkhart, Indiana
  19. Mishawaka, Indiana
  20. South Bend, Indiana
  21. South Bend, Indiana
  22. Iowa City, Iowa
  23. Louisville, Kentucky
  24. Baltimore, Maryland
  25. Owings Mills, Maryland
  26. Boston, Massachusetts
  27. Golden Valley, Minnesota
  28. Minneapolis, Minnesota
  29. Kansas City, Missouri
  30. Kansas City, Missouri
  31. Warrenburg, Missouri
  32. Concord, New Hampshire
  33. South Plainfield, New Jersey
  34. Charlotte, North Carolina
  35. Charlotte, North Carolina
  36. Charlotte, North Carolina
  37. Matthews, North Carolina
  38. Monroe, North Carolina
  39. Portland, Oregon
  40. Portland, Oregon
  41. Wyomissing, Pennsylvania
  42. Charleston, South Carolina
  43. Mount Pleasant, South Carolina
  44. Memphis, Tennessee
  45. Austin, Texas
  46. Galveston, Texas
  47. Houston, Texas
  48. Charlottesville, Virginia
  49. Richmond, Virginia
  50. Richmond, Virginia
  51. Tacoma, Washington
  52. Madison, Wisconsin
  53. Madison, Wisconsin
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study of Glaucoma or Ocular Hypertension in Patients Within the United States
Official Title  ICMJE A 6-Month, Randomized, Double-Masked Comparison of Fixed Combination of Latanoprost and Timolol With the Individual Components, Continuing Into a 6-Month Open Label Safety Study of Fixed Combination in Patients With Glaucoma or Ocular Hypertension. A Multicenter Study in the United States
Brief Summary Safety and efficacy study comparing between fixed combination latanoprost-timolol and its component parts.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Ocular Hypertension
  • Glaucoma
Intervention  ICMJE
  • Drug: latanoprost 0.005%
    placebo in the morning and latanoprost .005% in the evening
  • Drug: fixed combination latanoprost-timolol
    one drop in the morning and placebo in the evening
  • Drug: timolol 0.5%
    one drop in the morning and evening
Study Arms  ICMJE
  • Experimental: Fixed combination of latanoprost 0.005% and timolol 0.5%
    Intervention: Drug: fixed combination latanoprost-timolol
  • Active Comparator: latanoprost 0.005%
    Intervention: Drug: latanoprost 0.005%
  • Active Comparator: Timolol - 0.5%
    Intervention: Drug: timolol 0.5%
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: December 1, 2008)
418
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 1999
Actual Primary Completion Date June 1999   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Unilateral or bilateral primary open angle glaucoma, capsular glaucoma, pigmentary glaucoma or ocular hypertension.
  • Patients currently on IOP reducing therapy: IOP greater than or equal to 25mmHg (Ltwo IOP determinations at pre-study separated by at least one hour) OR Patients without IOP reducing therapy: IOP greater than or equal to 30mmHg (two IOP determinations at pre-study separated by at least one hour).

Exclusion Criteria:

  • History of acute angle closure or closed/barely open anterior chamber angle.
  • Current use of contact lenses.
  • Ocular surgery or argon laser trabeculoplasty (ALT) within three months prior to pre-study visit.
  • Ocular inflammation/infection occurring within three months prior to pre-study visit.
  • Hypersensitivity to benzalkonium chloride or to any other component of the study drug solutions.
  • Other abnormal ocular condition or symptom preventing the patient from entering the study, according to the investigator's judgement.
  • Patients with conditions in which treatment with B-blocking agents are contraindicated: cardiac failure, sinus bradycardia, second and third degree atrio-ventricular block.
  • Patients with conditions in which treatment with B-blocking agents are contraindicated: bronchial asthma, history of bronchial asthma or chronic obstructive pulmonary disease.
  • Inability to adhere to treatment/visit plan.
  • Have participated in any other clinical study within one month prior to pre-study visit.
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00800267
Other Study ID Numbers  ICMJE 96TIPG005
A6641006
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2009

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