Azopt (Brinzolamide 1.0%) Plus Travatan (Travoprost 0.004%) in Treating Patients With Chronic Angle-Closure Glaucoma (CACG)

November 13, 2023 updated by: Alcon Research

A Double-Masked, Parallel-Group, Efficacy and Safety Study of Brinzolamide 1.0% (AZOPT) as Adjunctive Therapy to Travoprost 0.004% (TRAVATAN) in Patients With Chronic Angle-Closure Glaucoma

To evaluate the IOP (Intraocular Pressure) lowering efficacy and safety of Brinzolamide 1.0% (Azopt), dosed twice daily as adjunctive therapy in patients treated with Travoprost 0.004% (Travatan) once daily. The study is double masked. The patients will receive either treatment for 12 weeks.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Phase 4

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

  • United States
    • Texas
      • Fort Worth, Texas, United States, 76134
        • Alcon Call Center

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

Description

Inclusion Criteria:

  • ≥ 18 years;
  • CACG (Chronic Angle Closure Glaucoma) ≥ 1eye
  • have been treated with PGA (prostaglandin analogues) once daily ≥ 2 weeks prior to the screening visit and IOP=19-32 mmHg (millimeters mercury) in at least one eye and ≤ 32 mmHg in both eyes
  • clinical stability of VA (Visual Acuity) and optic nerve throughout the study

Exclusion Criteria:

  • Abnormality restricts exam of the fundus or anderior chamber
  • conjunctivitis, keratitis or uveitis
  • unable to be discontinued from using all ocular hypotensive medication(s) except Travatan (Travoprost 0.004%) and/or Azopt (Brinzolamide 1.0%) for 12days-4weeks
  • ocular surgery prior to the study

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Travoprost 0.004% + Brinzolamide 1.0%
Travoprost 0.004% (once daily) + Brinzolamide 1.0% (twice daily)
Drug: Travoprost 0.004% + Brinzolamide 1.0%
Travoprost 0.004% (once daily) + Brinzolamide 1.0% (twice daily)
Active Comparator: Travoprost 0.004% + Tears Natural
Travoprost 0.004% (once daily) + Tears Naturale (twice daily)
Drug: Travoprost 0.004% + Tears Natural
Travoprost 0.004% (once daily) + Tears Naturale (twice daily)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean IOP (Intraocular Pressure)
Time Frame: Screening: Week 12; (At 9 am and 4 pm time points)
Screening: Week 12; (At 9 am and 4 pm time points)

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

May 1, 2006

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

September 23, 2008

First Submitted That Met QC Criteria

September 24, 2008

First Posted (Estimated)

September 25, 2008

Study Record Updates

Last Update Posted (Estimated)

December 5, 2023

Last Update Submitted That Met QC Criteria

November 13, 2023

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS-06-01

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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