Azopt Plus Travatan in Treating Patients With Chronic Angle-Closure Glaucoma (CACG)

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

Date First Received: September 23, 2008

Last Updated: September 24, 2008

Verified by: Alcon Research, September 2008

Clinical Trial Phase: Phase 4 | Start Date: May 2006

Overall Status: Terminated

Estimated Enrollment: 37

Brief Summary

Official Title: “A Double-Masked, Parallel-Group, Efficacy and Safety Study of Brinzolamide 1.0% as Adjunctive Therapy to Travoprost 0.004% in Patients With Chronic Angle-Closure Glaucoma”

Condition Keyword(s):

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment

Study Primary Completion Date: March 2008

Intervention(s) in this Clinical Trial

  • Drug: Travoprost 0.004% + Brinzolamide 1.0%
    • Travoprost 0.004% (q.d.) + Brinzolamide 1.0% (bid)
  • Drug: Travoprost 0.004% + Tears Natural
    • Travoprost 0.004% (q.d.) + Tears Naturale (bid)

Arms, Groups and Cohorts in this Clinical Trial

  • Active Comparator: 1
    • Active Eyedrop
  • Placebo Comparator: 2
    • Placebo Eyedrop

Outcome Measures for this Clinical Trial

Primary Measures

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

Secondary Measures

  • Best corrected visual acuity
    • Time Frame: Screening; Week 4; Week 12
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • ≥18 years;CACG ≥1eye;have been treated with PGA once daily ≥2 weeks prior to the screening visit and IOP=19-32 mmHg in at least one eye and ≤ 32 mmHg in both eyes;clinical stability of VA 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 and/or Azopt 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 Sponsor Information

Lead Sponsor: Alcon Research

Additional Information

Information obtained from ClinicalTrials.gov on July 02, 2009

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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