IOP Lowering Efficacy of Travoprost/Brinzolamide Fixed Combination Ophthalmic Suspension in Patients With Open-Angle Glaucoma or Ocular Hypertension

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00527501
• Collaborator: (none)
• Enrollment: 136
• Location: 1
• Duration (Months): 4
• Patients Per Site Per Month: 33.9

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the safety and IOP-lowering efficacy of a fixed combination of Travoprost/Brinzolamide Ophthalmuc Suspension dosed BID and QD, to TRAVATAN dosed QD and a Vehicle dosed BID in patients with open-angle glaucoma or ocular hypertension.

Condition or Disease	Intervention/Treatment	Phase
Open-angle Glaucoma; Ocular Hypertension	Drug: Travoprost/brinzolamide	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 136 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: IOP Lowering Efficacy of Travoprost/Brinzolamide Fixed Combination Ophthalmic Suspension in Patients With Open-Angle Glaucoma or Ocular Hypertension
• Study Start Date: Aug 1, 2007
• Actual Primary Completion Date: Dec 1, 2007
• Actual Study Completion Date: Dec 1, 2007

Outcome Measures

Primary Outcome Measures

1. Mean IOP [Time]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients 18 years of age or older of either sex and any race with diagnosed open-angle glaucoma or confirmed ocular hypertension

Exclusion Criteria:

• Age (Under 18)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Artesia	Artesia	California	United States	90701

Sponsors and Collaborators

• Alcon Research

Investigators

• Study Director: Theresa Landry, Alcon Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT00527501
• Other Study ID Numbers: C-07-07
• First Posted: Sep 11, 2007
• Last Update Posted: Apr 16, 2012
• Last Verified: Feb 1, 2008

• Keywords provided by Alcon Research: Open-angle glaucoma; ocular hypertension
• Additional relevant MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Travoprost; Brinzolamide

Study Results

No Results Posted as of Apr 16, 2012