1 Year Study Trav/Brinz QD Fixed Combination Versus COSOPT

July 18, 2012 updated by: Alcon Research
Parallel, Multi-Center, Double-masked, Active controlled, three arm study comparing the IOP lowering efficacy and safety over 12 months of morning or evening instillations of Travoprost/Brinzolamide vs. Cosopt dosed in the morning and evening in patients with open-angle glaucoma or ocular hypertension.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico City, Mexico, 6700

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:

  • IOP at screening visit <18mmHg in at least one eye Mean IOP in same eye (at both eligibility 1 &2 visits)

    • 24 and ≤ 36 mmHg at 9:00
    • 21 and ≤ 36 mmHg at 11:00 and 16:00

Exclusion Criteria:

  • Severe central visual field loss Angle Shaffer grade < 2 C/D ratio > 0.8 (horizontal or vertical measurement)

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Travoprost/Brinzolamide PM, Vehicle AM
Drug: Travoprost/Brinzolamide
Eye drop suspension, once daily
Experimental: Travoprost/Brinzolamide AM, Vehicle PM
Drug: Travoprost/Brinzolamide
Eye drop suspension, once daily
Active Comparator: Cosopt
Cosopt BID
Drug: Cosopt
Eye drop solution, one drop BID

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean IOP
Time Frame: 9:00,11:00, and 1600 time points at month 12
9:00,11:00, and 1600 time points at month 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent change in IOP, IOP change from baseline, patients with IOP <18mmHg. BSCVA, Ocular signs, Dilated fundus, perimetry, pachymetry, cardiovascular parameters(pulse, BP and AEs at W2, W3, M6, M9 and M12.
Time Frame: All on therapy time points not included in primary efficacy
All on therapy time points not included in primary efficacy

Collaborators and Investigators

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

Sponsor

Alcon Research

Collaborators

PPD

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, 2008

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

October 3, 2008

First Submitted That Met QC Criteria

October 6, 2008

First Posted (Estimate)

October 7, 2008

Study Record Updates

Last Update Posted (Estimate)

July 19, 2012

Last Update Submitted That Met QC Criteria

July 18, 2012

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-08-16
  • 2008-002781-66

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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