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1 Year Study Trav/Brinz QD Fixed Combination Versus COSOPT

NCT ID: NCT00767481

Last Updated: 2012-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Glaucoma Ocular Hypertension

Keywords

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glaucoma Patients with open-angle glaucoma or ocular hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Travoprost/Brinzolamide PM, Vehicle AM

Travoprost/Brinzolamide PM, Vehicle AM

Group Type EXPERIMENTAL

Travoprost/Brinzolamide

Intervention Type DRUG

Eye drop suspension, once daily

Travoprost/Brinzolamide AM, Vehicle PM

Travoprost/Brinzolamide AM, Vehicle PM

Group Type EXPERIMENTAL

Travoprost/Brinzolamide

Intervention Type DRUG

Eye drop suspension, once daily

Cosopt

Cosopt BID

Group Type ACTIVE_COMPARATOR

Cosopt

Intervention Type DRUG

Eye drop solution, one drop BID

Interventions

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Travoprost/Brinzolamide

Eye drop suspension, once daily

Intervention Type DRUG

Cosopt

Eye drop solution, one drop BID

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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PPD Development, LP

INDUSTRY

Sponsor Role collaborator

Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Mexico City, , Mexico

Site Status

Countries

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United States Mexico

Other Identifiers

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2008-002781-66

Identifier Type: -

Identifier Source: secondary_id

C-08-16

Identifier Type: -

Identifier Source: org_study_id