Clinical Trial: Observational Study of the Long-term Effect of Latanoprost in Normal Tension Glaucoma

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Prospective, Observational Study to Investigate the Long-term Effect of Xalatan® on Intraocular Pressure (IOP) and on Maintenance of Visual Field in Patients With Normal Ten

Brief Summary: The purpose of this study is to assess the long-term efficacy and safety of latanoprost monotherapy in patients with normal tension glaucoma (NTG) using a prospective, observational design. Visits were scheduled at 6-month intervals for 24 months. Intraocular pressure (IOP), optic nerve head findings, visual field status, and adverse events were recorded.

Detailed Summary:
Sponsor: Pfizer

Current Primary Outcome:

  • Change From Baseline in Raw Intraocular Pressure (IOP) by Visit [ Time Frame: Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit ]
    Mean IOP values measured by applanation tonometry or noncontact method; valid range: 8-40 millimeters of mercury (mmHg). Only the IOP reading for the eye treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed. Last visit = last post-baseline visit at which participant provides a value of IOP.
  • Number of Participants With a 24-Hour Intraocular Pressure (IOP) Profile: Month 12 [ Time Frame: Month 12 ]
    Response: Yes = had an IOP 24-hour profile; No = did not have an IOP 24-hour profile.
  • Number of Participants With a 24-Hour Intraocular Pressure (IOP) Profile: Month 24 [ Time Frame: Month 24 ]
    Response: Yes = had an IOP 24-hour profile; No = did not have an IOP 24-hour profile.
  • Number of Participants Per Visit With Intraocular Pressure (IOP) 24-Hour Pressure Peaks: Month 12 [ Time Frame: Month 12 ]
    Response: Yes = had IOP 24-hour pressure peak; No = did not have IOP 24-hour pressure peak.
  • Number of Participants Per Visit With Intraocular Pressure (IOP) 24-Hour Pressure Peaks: Month 24 [ Time Frame: Month 24 ]
    Response: Yes = had IOP 24-hour pressure peak; No = did not have IOP 24-hour pressure peak.
  • Percentage of Participants Who Achieved Intraocular Pressure (IOP) Target at Last Visit [ Time 

    Original Primary Outcome:

    • Change From Baseline in Raw Intraocular Pressure (IOP) by Visit [ Time Frame: Month 6 ]
      Mean IOP values measured in millimeters of mercury (mmHg) by applanation tonometry and noncontact method; range: 8-40 mmHg. A higher IOP increaes the risk of glaucoma. Only the IOP reading for the eye treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.
    • Percent of Subjects with an Intraocular Pressure (IOP) 24-Hour Profile per Visit [ Time Frame: Month 12 ]
      Response: Yes = had an IOP 24-hour profile; No = did not have an IOP 24-hour profile.
    • Number of Subjects per Visit with Intraocular Pressure (IOP) 24-Hour Pressure Peaks [ Time Frame: Month 12 ]
      Response: Yes = had IOP 24-hour pressure peak; No = did not have IOP 24-hour pressure peak.
    • Percent of Subjects at Last Visit who Achieved Intraocular Pressure Target [ Time Frame: Month 24 (final visit) ]
      Response: Yes = achieved IOP target at last vist; No = did not achieve IOP target at last visit.
    • Change From Baseline by Visit in Optic Disc Excavation: Horizontal Cup to Disc Ratio [ Time Frame: Month 6 ]
      Mean horizontal cup to disc (cup/disc or C/D) ratio measured by slit lamp examination to assess progression of glaucoma; calculated as the ratio of the diameter of the depression (cup) to that of the optical nerve head (disc). Valid range: 0.1-1.0; a high cup/disc ratio may imply glaucoma.
    • Change F

      Current Secondary Outcome:

      Original Secondary Outcome:

      Information By: Pfizer

      Dates:
      Date Received: September 23, 2010
      Date Started: August 2006
      Date Completion:
      Last Updated: July 7, 2011
      Last Verified: June 2011