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1 Year Study Trav/Brinz QD Fixed Combination Versus COSOPT

Primary Purpose

Glaucoma, Ocular Hypertension

Status
Terminated
Phase
Phase 3
Locations
Mexico
Study Type
Interventional
Intervention
Travoprost/Brinzolamide
Cosopt
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring glaucoma, Patients with open-angle glaucoma or ocular hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Travoprost/Brinzolamide PM, Vehicle AM

Travoprost/Brinzolamide AM, Vehicle PM

Cosopt

Arm Description

Travoprost/Brinzolamide PM, Vehicle AM

Travoprost/Brinzolamide AM, Vehicle PM

Cosopt BID

Outcomes

Primary Outcome Measures

Mean IOP

Secondary Outcome 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.

Full Information

First Posted
October 3, 2008
Last Updated
July 18, 2012
Sponsor
Alcon Research
Collaborators
PPD
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1. Study Identification

Unique Protocol Identification Number
NCT00767481
Brief Title
1 Year Study Trav/Brinz QD Fixed Combination Versus COSOPT
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Terminated
Why Stopped
Project Cancelled
Study Start Date
October 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
Collaborators
PPD

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Ocular Hypertension
Keywords
glaucoma, Patients with open-angle glaucoma or ocular hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Travoprost/Brinzolamide PM, Vehicle AM
Arm Type
Experimental
Arm Description
Travoprost/Brinzolamide PM, Vehicle AM
Arm Title
Travoprost/Brinzolamide AM, Vehicle PM
Arm Type
Experimental
Arm Description
Travoprost/Brinzolamide AM, Vehicle PM
Arm Title
Cosopt
Arm Type
Active Comparator
Arm Description
Cosopt BID
Intervention Type
Drug
Intervention Name(s)
Travoprost/Brinzolamide
Intervention Description
Eye drop suspension, once daily
Intervention Type
Drug
Intervention Name(s)
Cosopt
Intervention Description
Eye drop solution, one drop BID
Primary Outcome Measure Information:
Title
Mean IOP
Time Frame
9:00,11:00, and 1600 time points at month 12
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
City
Mexico City
ZIP/Postal Code
6700
Country
Mexico

12. IPD Sharing Statement

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1 Year Study Trav/Brinz QD Fixed Combination Versus COSOPT

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