Success of Transitioning Uncontrolled Glaucoma Patients From Prior Mono or Adjunctive Therapy to DuoTrav

NCT ID: NCT00519753

Last Updated: 2016-11-18

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

522 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2008-12-31

Brief Summary

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The purpose of this study is to assess the safety and efficacy of transitioning uncontrolled glaucoma patients to DuoTrav from other mono or adjunctive therapies.

Detailed Description

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Conditions

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Glaucoma

Keywords

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Glaucoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DuoTrav

One drop in study eye(s) once daily in the evening (at 8:00 PM) for 12 weeks

Group Type EXPERIMENTAL

Travoprost 0.004%/timolol maleate 0.5% fixed combination ophthalmic solution (DuoTrav)

Intervention Type DRUG

One drop in study eye(s) once daily in the evening (at 8:00 PM) for 12 weeks

Interventions

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Travoprost 0.004%/timolol maleate 0.5% fixed combination ophthalmic solution (DuoTrav)

One drop in study eye(s) once daily in the evening (at 8:00 PM) for 12 weeks

Intervention Type DRUG

Other Intervention Names

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DUOTRAV®

Eligibility Criteria

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Inclusion Criteria

* Adults with primary open-angle glaucoma, ocular hypertension or pigment dispersion glaucoma.

Exclusion Criteria

* Age related.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark C Jasek

Role: STUDY_DIRECTOR

Alcon Research

Locations

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Mainz

Mainz, , Germany

Site Status

Countries

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Germany

References

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Pfeiffer N, Scherzer ML, Maier H, Schoelzel S, Jasek MC, Stewart JA, Stewart WC. Safety and efficacy of changing to the travoprost/timolol maleate fixed combination (DuoTrav) from prior mono- or adjunctive therapy. Clin Ophthalmol. 2010 May 14;4:459-66. doi: 10.2147/opth.s10694.

Reference Type RESULT
PMID: 20505839 (View on PubMed)

Other Identifiers

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CMS-06-12

Identifier Type: -

Identifier Source: org_study_id