Phase III Safety and Efficacy Study to Evaluate a Glaucoma Therapy in Open-Angle Glaucoma or Ocular Hypertension Patients

August 16, 2012 updated by: Alcon Research
The purpose of this study is to determine the safety and IOP-lowering ability of a glaucoma therapy in patients with open-angle glaucoma or ocular hypertension

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

690

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult subjects of either sex and any race 18 years or older with open-angle glaucoma or ocular hypertension. Patients with logMAR visual acuity not worse than 0.6 in either eye or any clinically relevant ophthalmic/systemic condition will be excluded.

Exclusion Criteria:

  • See Inclusion Criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (Actual)

June 1, 2005

Study Completion (Actual)

June 1, 2005

Study Registration Dates

First Submitted

February 7, 2006

First Submitted That Met QC Criteria

February 7, 2006

First Posted (Estimate)

February 9, 2006

Study Record Updates

Last Update Posted (Estimate)

August 17, 2012

Last Update Submitted That Met QC Criteria

August 16, 2012

Last Verified

September 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-04-17

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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