Mechanism of Action of TRAVATAN 0.004% in Subjects With Glaucoma or Ocular Hypertension

The primary objective of this study is to describe the effect of TRAVATAN 0.004% Ophthalmic Solution on aqueous humor dynamics in subjects with a clinical diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT)...

Date First Received: May 28, 2003

Last Updated: August 4, 2008

Verified by: Alcon Research, August 2008

Clinical Trial Phase: Phase 4 | Start Date: April 2003

Overall Status: Completed

Brief Summary

Official Title: “A Double-Masked, Placebo-Controlled, Paired Comparison Study of the Mechanism of Action of TRAVATAN 0.004% in Subjects With Glaucoma or Ocular Hypertension”

Condition Keyword(s):

Intervention(s):

The primary objective of this study is to describe the effect of TRAVATAN 0.004% Ophthalmic Solution on aqueous humor dynamics in subjects with a clinical diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT).

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: March 2004

Intervention(s) in this Clinical Trial

  • Drug: Travoprost

Criteria for Participation in this Clinical Trial

  • Subjects 18 years of age or older
  • of either sex
  • of any race
  • diagnosed with ocular hypertension or open angle glaucoma

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 Sponsor Information

Lead Sponsor: Alcon Research

Additional Information

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00061503

Study ID Number: C-01-55

ClinicalTrials.gov Identifier: NCT00061503

Health Authority: United States: Food and Drug Administration

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