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A 12-Month Study to Evaluate the Efficacy and Safety of Once-Daily Instillation of Combination Glaucoma Therapy in Patients With Open-Angle Glaucoma or Ocular Hypertension

NCT ID: NCT00311389

Last Updated: 2012-02-14

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

PHASE3

Total Enrollment

408 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2004-09-30

Brief Summary

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The purpose of this study is to evaluate the intraocular pressure(IOP)-lowering efficacy of a combination IOP-lowering therapy in patients with open-angle glaucoma or ocular hypertension.

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Detailed Description

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Conditions

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Glaucoma, Open-angle Ocular Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Travoprost/Timolol

1 drop in the affected eye(s) once daily in the morning for 12 months

Group Type EXPERIMENTAL

Travoprost 0.004%/Timolol maleate 0.5% ophthalmic solution

Intervention Type DRUG

Investigational ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension

Latanoprost/Timolol

1 drop in the affected eye(s) once daily in the morning for 12 months

Group Type ACTIVE_COMPARATOR

Latanoprost 0.005%/Timolol 0.005% ophthalmic solution

Intervention Type DRUG

Commercially marketed ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension

Interventions

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Travoprost 0.004%/Timolol maleate 0.5% ophthalmic solution

Investigational ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension

Intervention Type DRUG

Latanoprost 0.005%/Timolol 0.005% ophthalmic solution

Commercially marketed ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\- As specified in protocol

Exclusion Criteria

\- As specified in protocol
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

Locations

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European Facilitiies

Puurs, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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C-02-28

Identifier Type: -

Identifier Source: org_study_id

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