1 Year Study Trav/Brinz QD Fixed Combination Versus COSOPT

Verified by: Alcon Research, November 2011
First Received: October 3, 2008 | Last Updated: November 16, 2011 | Phase: Phase 3 | Start Date: October 2008
Overall Status: Terminated | Estimated Enrollment: 6
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Parallel, Multi-Center, Double-masked, Active controlled, three arm study comparing the IOP lowering efficacy and safety over 12 months of morning or evening instillations of Travoprost/Brinzolamide vs. Cosopt dosed in the morning and evening in patients with open-angle glaucoma or ocular hypertension...

Brief Summary

Parallel, Multi-Center, Double-masked, Active controlled, three arm study comparing the IOP lowering efficacy and safety over 12 months of morning or evening instillations of Travoprost/Brinzolamide vs. Cosopt dosed in the morning and evening in patients with open-angle glaucoma or ocular hypertension.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
  • Study Primary Completion Date: February 2009

Intervention(s) in this Clinical Trial

  • Drug: Travoprost/Brinzolamide
    • Eye drop suspension, once daily
  • Drug: Cosopt
    • Eye drop solution, one drop BID

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: Travoprost/Brinzolamide PM, Vehicle AM
    • Travoprost/Brinzolamide PM, Vehicle AM
  • Experimental: Travoprost/Brinzolamide AM, Vehicle PM
    • Travoprost/Brinzolamide AM, Vehicle PM
  • Active Comparator: Cosopt
    • Cosopt BID

Outcome Measures for this Clinical Trial

Primary Measures

  • Mean IOP
    • Time Frame: 9:00,11:00, and 1600 time points at month 12
      Safety Issue?: Yes

Secondary Measures

  • Percent change in IOP, IOP change from baseline, patients with IOP <18mmHg. BSCVA, Ocular signs, Dilated fundus, perimetry, pachymetry, cardiovascular parameters(pulse, BP and AEs at W2, W3, M6, M9 and M12.
    • Time Frame: All on therapy time points not included in primary efficacy
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • IOP at screening visit <18mmHg in at least one eye Mean IOP in same eye (at both eligibility 1 &2 visits)
  • 24 and ≤ 36 mmHg at 9:00
  • 21 and ≤ 36 mmHg at 11:00 and 16:00

Exclusion Criteria:

  • Severe central visual field loss Angle Shaffer grade < 2 C/D ratio > 0.8 (horizontal or vertical measurement)

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 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00767481

Study ID Number: C-08-16

ClinicalTrials.gov Identifier: NCT00767481

Health Authority: Argentina: Ministry of Health

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