Travoprost/Brinzolamide Fixed Combination Versus Travatan... | NCT00767494

Studies
Travoprost/Brinzolamide Fixed Combination Versus Travatan and Versus AZOPT

NCT00767494

Sponsor

Alcon Research

Status

Terminated

Last Update Posted

Sep 19, 2012Estimated

Enrollment

17Actual

Phase

Phase 3

Conditions

Glaucoma
Ocular Hypertension

Interventions

Travoprost/Brinzolamide fixed combination
Azopt
Travatan

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2009

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Project Cancelled

Expanded Access Info

Start Date

Oct 2008

Primary Completion Date

Feb 2009Actual

Completion Date

Feb 2009Actual

First Submitted Date

Oct 3, 2008

First Submission Date that Met QC Criteria

Oct 6, 2008

First Posted Date

Oct 7, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 18, 2012

Last Update Posted Date

Sep 19, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

17Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Travoprost/Brinzolamide AM, Vehicle PM	Drug: Travoprost/Brinzolamide fixed combination
2	Experimental	Travoprost/Brinzolamide PM, Vehicle AM	Drug: Travoprost/Brinzolamide fixed combination
3	Active Comparator	AZOPT AM and PM	Drug: Azopt
4	Active Comparator	TRAVATAN PM, Vehicle AM	Drug: Travatan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Travoprost/Brinzolamide fixed combination	Drug	Eye Drops, suspension once daily	1 2

Measure	Description	Time Frame
Mean IOP		9, 11, and 16:00 time points at Week 12

Measure	Description	Time Frame
Mean diurnal IOP at Week 12		results pooled across 9,11, and 16:00 time points

Eligibility Module

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 â‰¥ 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D003008	Cloprostenol
D011461	Prostaglandins F, Synthetic
D011465	Prostaglandins, Synthetic
D011453	Prostaglandins

ID	Term
D005901	Glaucoma
D009798	Ocular Hypertension
D005902	Glaucoma, Open-Angle

ID	Term
D000069557	Travoprost
C111827	brinzolamide