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

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.
 
ClinicalTrials.gov Identifier: NCT00758342
Recruitment Status : Terminated (difficulty of enrolling patients)
First Posted : September 25, 2008
Results First Posted : February 5, 2010
Last Update Posted : March 2, 2010
Sponsor:
Information provided by:
Alcon Research

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Intraocular Pressure Drug: Travoprost 0.004% + Brinzolamide 1.0% Drug: Travoprost 0.004% + Tears Natural Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
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
Study Start Date : May 2006
Actual Primary Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma Tears

Arms and Interventions
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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)


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

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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United States, Texas
Alcon Call Center
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
More Information
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Responsible Party: Benny Li, Regional Scientific Clinical Affaires Manager, Alcon Research
ClinicalTrials.gov Identifier: NCT00758342    
Other Study ID Numbers: MS-06-01
First Posted: September 25, 2008    Key Record Dates
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:
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Glaucoma
Glaucoma, Angle-Closure
Ocular Hypertension
Eye Diseases
Travoprost
 Brinzolamide
Antihypertensive Agents
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action