We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been terminated.
(difficulty of enrolling patients)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00758342
First Posted: September 25, 2008
Last Update Posted: March 2, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Alcon Research
  Purpose
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.

Condition Intervention Phase
Intraocular Pressure Drug: Travoprost 0.004% + Brinzolamide 1.0% Drug: Travoprost 0.004% + Tears Natural Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean IOP (Intraocular Pressure) [ Time Frame: Screening: Week 12; (At 9 am and 4 pm time points) ]

Enrollment: 37
Study Start Date: May 2006
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00758342


Locations
United States, Texas
Alcon Call Center
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
  More Information

Responsible Party: Benny Li, Regional Scientific Clinical Affaires Manager, Alcon Research
ClinicalTrials.gov Identifier: NCT00758342     History of Changes
Other Study ID Numbers: MS-06-01
First Submitted: September 23, 2008
First Posted: September 25, 2008
Results First Submitted: September 10, 2009
Results First Posted: February 5, 2010
Last Update Posted: March 2, 2010
Last Verified: February 2010

Keywords provided by Alcon Research:
IOP lowering efficacy and safety of Azopt plus Travatan

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Angle-Closure
Ocular Hypertension
Eye Diseases
Travoprost
Brinzolamide
Antihypertensive Agents
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action