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Travoprost/Brinzolamide Fixed Combination Versus Travatan and Versus AZOPT

Primary Purpose

Glaucoma, Ocular Hypertension

Status
Terminated
Phase
Phase 3
Locations
Belgium
Study Type
Interventional
Intervention
Travoprost/Brinzolamide fixed combination
Azopt
Travatan
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 OAG, OH, Open-angle glaucoma or ocular hypertension

Eligibility Criteria

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

Inclusion Criteria:

  • 18 YOA or older
  • Either gender or any race
  • OAG or OHT
  • Currently on stable (at least 4 weeks) IOP lowering medication
  • 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 9AM
  • 21 and 36 mmHg at 11AM and 4PM
  • Able to discontinue use of IOP lowering medication for a minimum wash out period of 5 to 28 days prior to eligibility visit 1

Exclusion Criteria:

Related to disease condition being investigated (OAG or OHT) in either eye

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

Related to ocular patient history or current ocular condition in either eye

  • BSCVA worse than 55 ETDRS letters read (equivalent to approximately 20/80 Snellen or 0.25 decimal)
  • Ocular infection or inflammation or laser surgery within the last 3 months
  • Intraocular surgery or trauma with the last 6 months
  • Any abnormality preventing reliable applanation tonometry
  • History or chronic, recurrently or current severe inflammatory disease
  • History of or current clinically significant or progressive retinal disease
  • History of or current ocular pathology(including severe dry eye) that would affect the conduct of the study

Related to systemic or ocular medication in either eye

  • Allergy/hypersensitivity to study medications
  • Unable to discontinue glucocorticoid at least 4 weeks prior to the study or unable to remain off these medications during the study period
  • Use of oral CAIs during the study
  • Recent use (<4 weeks prior to the study) of Aspirin (>1 gram)
  • Less than 30 days stable dosing regimen of medications used on a chronic basis that may affect IOP
  • Therapy with another investigational agent within 30 days prior to the Screening Visit

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

1

2

3

4

Arm Description

Travoprost/Brinzolamide AM, Vehicle PM

Travoprost/Brinzolamide PM, Vehicle AM

AZOPT AM and PM

TRAVATAN PM, Vehicle AM

Outcomes

Primary Outcome Measures

Mean IOP

Secondary Outcome Measures

Mean diurnal IOP at Week 12

Full Information

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

Unique Protocol Identification Number
NCT00767494
Brief Title
Travoprost/Brinzolamide Fixed Combination Versus Travatan and Versus AZOPT
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is to compare the IOP lowering efficacy of Travoprost/Brinzolamide dosed daily in the morning or evening, vs TRAVATAN dosed once daily in the evening, and vs. AZOPT dosed BID 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
OAG, OH, Open-angle glaucoma or ocular hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Travoprost/Brinzolamide AM, Vehicle PM
Arm Title
2
Arm Type
Experimental
Arm Description
Travoprost/Brinzolamide PM, Vehicle AM
Arm Title
3
Arm Type
Active Comparator
Arm Description
AZOPT AM and PM
Arm Title
4
Arm Type
Active Comparator
Arm Description
TRAVATAN PM, Vehicle AM
Intervention Type
Drug
Intervention Name(s)
Travoprost/Brinzolamide fixed combination
Intervention Description
Eye Drops, suspension once daily
Intervention Type
Drug
Intervention Name(s)
Azopt
Intervention Description
Eye Drop Suspension, 1 drop BID
Intervention Type
Drug
Intervention Name(s)
Travatan
Intervention Description
Eye Drop Solution, 1 drop BID
Primary Outcome Measure Information:
Title
Mean IOP
Time Frame
9, 11, and 16:00 time points at Week 12
Secondary Outcome Measure Information:
Title
Mean diurnal IOP at Week 12
Time Frame
results pooled across 9,11, and 16:00 time points

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 YOA or older Either gender or any race OAG or OHT Currently on stable (at least 4 weeks) IOP lowering medication 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 9AM 21 and 36 mmHg at 11AM and 4PM Able to discontinue use of IOP lowering medication for a minimum wash out period of 5 to 28 days prior to eligibility visit 1 Exclusion Criteria: Related to disease condition being investigated (OAG or OHT) in either eye Severe central visual field loss Angle shaffer grade < 2 C/D ratio >0.8(horizontal or vertical measurement) Related to ocular patient history or current ocular condition in either eye BSCVA worse than 55 ETDRS letters read (equivalent to approximately 20/80 Snellen or 0.25 decimal) Ocular infection or inflammation or laser surgery within the last 3 months Intraocular surgery or trauma with the last 6 months Any abnormality preventing reliable applanation tonometry History or chronic, recurrently or current severe inflammatory disease History of or current clinically significant or progressive retinal disease History of or current ocular pathology(including severe dry eye) that would affect the conduct of the study Related to systemic or ocular medication in either eye Allergy/hypersensitivity to study medications Unable to discontinue glucocorticoid at least 4 weeks prior to the study or unable to remain off these medications during the study period Use of oral CAIs during the study Recent use (<4 weeks prior to the study) of Aspirin (>1 gram) Less than 30 days stable dosing regimen of medications used on a chronic basis that may affect IOP Therapy with another investigational agent within 30 days prior to the Screening Visit
Facility Information:
City
Brussels
Country
Belgium

12. IPD Sharing Statement

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Travoprost/Brinzolamide Fixed Combination Versus Travatan and Versus AZOPT

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