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

Verified by: Alcon Research, February 2010
First Received: September 23, 2008 | Last Updated: February 23, 2010 | Phase: Phase 4 | Start Date: May 2006
Overall Status: Terminated | Estimated Enrollment: 37
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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...

Brief Summary

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”

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 Type: Interventional
  • Study Design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
  • Study Primary Completion Date: March 2008

Intervention(s) in this Clinical Trial

  • Drug: Travoprost 0.004% + Brinzolamide 1.0%
    • Travoprost 0.004% (once daily) + Brinzolamide 1.0% (twice daily)
  • Drug: Travoprost 0.004% + Tears Natural
    • Travoprost 0.004% (once daily) + Tears Naturale (twice daily)

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: 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)

Outcome Measures for this Clinical Trial

Primary Measures

  • Mean IOP (Intraocular Pressure)
    • Time Frame: Screening: Week 12; (At 9 am and 4 pm time points)
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Alcon Research Industry

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00758342

Study ID Number: MS-06-01

ClinicalTrials.gov Identifier: NCT00758342

Health Authority: China: Ethics Committee

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