Travoprost New Formulations in Patients With Open-Angle Glaucoma or Ocular Hypertension

Verified by: Alcon Research, October 2008
First Received: April 29, 2008 | Last Updated: October 23, 2008 | Phase: Phase 2 | Start Date: April 2008
Overall Status: Completed | Estimated Enrollment: 150
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The purpose of this study is to describe the safety and IOP-lowering efficacy of Travoprost New Formulations compared to TRAVATAN and to vehicle in patients with open-angle glaucoma or ocular hypertension...

Brief Summary

The purpose of this study is to describe the safety and IOP-lowering efficacy of Travoprost New Formulations compared to TRAVATAN and to vehicle in patients with open-angle glaucoma or ocular hypertension.

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

Intervention(s) in this Clinical Trial

  • Drug: Travoprost
    • Ophthalmic Solution

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: 1
    • Travoprost New Formulations
  • Active Comparator: 2
    • Travatan
  • Placebo Comparator: 3
    • Vehicle

Outcome Measures for this Clinical Trial

Primary Measures

  • Mean IOP
    • Time Frame: from baseline
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Open-angle glaucoma
  • Ocular hypertension

Exclusion Criteria:

  • VA worse than 0.60

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 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/NCT00670033

Study ID Number: C-07-46

ClinicalTrials.gov Identifier: NCT00670033

Health Authority: United States: Food and Drug Administration

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00670033