A Phase III Study of Travoprost/Timolol Combination in Patients With Open-Angle Glaucoma or Ocular Hypertension

Verified by: Alcon Research, October 2009
First Received: May 2, 2008 | Last Updated: October 2, 2009 | Phase: Phase 3 | Start Date: May 2008
Overall Status: Completed | Estimated Enrollment: 264
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The purpose of this study is to demonstrate equivalent safety and IOP-lowering effectiveness of two Travoprost/Timolol combination products in patients diagnosed with open-angle glaucoma or ocular...

Brief Summary

The purpose of this study is to demonstrate equivalent safety and IOP-lowering effectiveness of two Travoprost/Timolol combination products in patients diagnosed with open-angle glaucoma or ocular hypertension

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
  • Study Primary Completion Date: December 2008

Intervention(s) in this Clinical Trial

  • Drug: Travoprost/Timolol Combination
    • Solution

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: 1
    • Travoprost/Timolol Combination
  • Active Comparator: 2
    • Travoprost/Timolol Combination

Outcome Measures for this Clinical Trial

Primary Measures

  • Mean IOP combined across all visits and time points
    • Time Frame: From baseline
      Safety Issue?: Yes

Secondary Measures

  • Percentage of patients with IOP<18 mmHg or IOP percent reduction of > pr = to 30%
    • Time Frame: From baseline
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Mean IOP in at least one eye, the same eye(s):22-36 mmHg at 9 AM on eligibility visits 1 & 2 and 21-36 mmHg at 11 AM and 4 PM on Eligibility Visits 1 & 2; satisfy all informed consent requirements

Exclusion Criteria:

  • Age related

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Alcon Research Industry

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00672997

Study ID Number: C-07-64

ClinicalTrials.gov Identifier: NCT00672997

Health Authority: United States: Food and Drug Administration

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00672997