Clinical Trial: Safety and Efficacy of Bimatoprost/Timolol Fixed Combination Versus Latanoprost in Patients With Open-Angle Glaucoma Who Have Never Been Treated

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title:

Brief Summary: This study will evaluate the safety and efficacy of bimatoprost/timolol fixed combination (GANfort®) versus latanoprost (Xalatan®) in patients with open-angle glaucoma who have never been previously treated and are at high risk for progression.

Detailed Summary:
Sponsor: Allergan

Current Primary Outcome: Change From Baseline in Average Intraocular Pressure (IOP) [ Time Frame: Baseline, Month 3 ]

IOP is a measurement of the fluid pressure inside the eye. For each patient, the IOP is the average of the two eyes. The average IOP is the average of the 08:00, 12:00 and 16:00 hour time points at each visit for each patient. A negative number change from Baseline indicates a reduction in average IOP (improvement).


Original Primary Outcome: Intraocular Pressure (IOP) [ Time Frame: 3 months ]

Current Secondary Outcome:

  • Change From Baseline IOP [ Time Frame: Baseline, Month 3 ]
    IOP is a measurement of the fluid pressure inside the eye. For each patient, the IOP is the average of the two eyes. IOP is recorded at the 08:00 (8:00 am), 12:00 (noon) and 16:00 (4:00 pm) hour time points for each patient at each visit. A negative number change from Baseline indicates a reduction in IOP (improvement).
  • Percentage of Patients Reaching a Predefined Target Pressure Threshold [ Time Frame: Baseline, Month 3 ]
    IOP is a measurement of the fluid pressure inside the eye. For each patient, the IOP is the average of the two eyes. The predefined target pressure thresholds are at least a 20%, 30%, 40%, and 50% reduction in IOP from baseline.
  • Absolute Difference Between Patient's Highest IOP Reading at Baseline (Day 0) and the Corresponding IOP Reading [ Time Frame: Baseline, Month 3 ]
    IOP is a measurement of the fluid pressure inside the eye. Two or three measurements of IOP are taken for each eye at each time point. The highest IOP values between the two eyes for each patient at each time point are used to calculate the absolute difference.
  • Absolute Difference Between Patient's Lowest IOP Reading at Baseline (Day 0) and the Corresponding IOP Reading [ Time Frame: Baseline, Month 3 ]
    IOP is a measurement of the fluid pressure inside the eye. Two or three measurements of IOP are taken for each eye at each time point. The lowest IOP values between the two eyes for each patient at each time point are used to calculate the absolute difference.


Original Secondary Outcome:

Information By: Allergan

Dates:
Date Received: November 17, 2010
Date Started: June 2010
Date Completion:
Last Updated: January 22, 2013
Last Verified: January 2013