1 Year Study Trav/Brinz QD Fixed Combination Versus COSOPT

Overview

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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: February 2009

Interventions

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

Arms, Groups and Cohorts

  • 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

Clinical Trial Outcome Measures

Primary Measures

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

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

Participating 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: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Alcon Research
  • Collaborator
    • PPD
  • Provider of Information About this Clinical Study
    • Sponsor

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.