A Phase IIIb Study of DuoTrav to Treat Glaucoma or Ocular Hypertension

NCT ID: NCT00465803

Last Updated: 2014-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31

Brief Summary

The purpose of this study is to assess patient compliance with DuoTrav versus concomitant administration of Timolol 0.5% plus TRAVATAN in patients with open-angle glaucoma or ocular hypertension.

Conditions

Open-angle Glaucoma; Ocular Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

DuoTrav

One drop in the study eye(s) once daily at either 8 AM or 8 PM for twelve months, as recorded by dosing aid

Group Type: OTHER

Travoprost 0.004%/timolol 0.5% ophthalmic solution

Intervention Type: DRUG

One drop in the study eye(s) once daily at either 8 AM or 8 PM for twelve months using the Dosing Aid

Travatan/Timolol

One drop Timolol in the study eye(s) once daily at 8 AM; one drop of Travatan in the study eye(s) once daily at 8 PM. Both products dosed for twelve months, as recorded by separate dosing aid for each product.

Group Type: OTHER

Travoprost ophthalmic solution, 0.004%

Intervention Type: DRUG

One drop in the study eye(s) once daily at 8 PM for twelve months using the Dosing Aid

Timolol maleate ophthalmic solution, 0.5%

Intervention Type: DRUG

One drop in the study eye(s) once daily at 8 AM or twelve months using the Dosing Aid

Interventions

Travoprost 0.004%/timolol 0.5% ophthalmic solution

One drop in the study eye(s) once daily at either 8 AM or 8 PM for twelve months using the Dosing Aid

Intervention Type: DRUG

Travoprost ophthalmic solution, 0.004%

One drop in the study eye(s) once daily at 8 PM for twelve months using the Dosing Aid

Intervention Type: DRUG

Timolol maleate ophthalmic solution, 0.5%

One drop in the study eye(s) once daily at 8 AM or twelve months using the Dosing Aid

Intervention Type: DRUG

Other Intervention Names

DuoTrav; TRAVATAN

Eligibility Criteria

Inclusion Criteria

• Adult patients with open-angle glaucoma or ocular hypertension;

Exclusion Criteria

• Visual acuity worse than 0.60;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Theresa Landry

Role: STUDY_DIRECTOR

Alcon Research

Locations

Seattle

Seattle, Washington, United States

Countries

United States

Other Identifiers

C-06-21

Identifier Type: -

Identifier Source: org_study_id