Official Title: “Comparison of Bimatoprost 0.03% Monotherapy vs. Dual Therapy With Travoprost 0.004% and Timolol 0.5% in Patients With Glaucoma and Ocular Hypertension”

Evaluate the IOP-lowering efficacy and quality of life in patients using bimatoprost 0.03% monotherapy versus dual therapy with travoprost 0.004% and timolol 0.5% for the treatment of glaucoma or ocular hypertension.

Study Type: Interventional

Study Design: Randomized, Single Blind, Active Control, Parallel Assignment

Intervention(s) in this Clinical Trial

• Drug: Bimatoprost 0.03%, Travoprost 0.004%, Timolol 0.5%

Inclusion Criteria:

• · Male or female > 18 years of age
• Diagnosis of primary open-angle glaucoma or ocular hypertension
• Untreated IOP > 18 mm Hg in each eye at the baseline evaluation
• Ability to provide informed consent and likely to complete all study visits

Exclusion Criteria:

• · Known contraindication to bimatoprost, travoprost, timolol, or any component of any study medication
• Uncontrolled systemic disease
• Active ocular disease other than POAG or ocular hypertension
• Required use of ocular medications other than the study medications during the study (intermittent use of OTC artificial tear products will be permitted)
• History of intraocular surgery within the last 3 months
• Patient must not have discontinued use of any medication included in this study in the past for reasons of efficacy or intolerance

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Lead Sponsor: Innovative Medical

Overall Clinical Trial Officials and Contacts

Robert Noecker, MD Principal Investigator UPMC Eye Center  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00348023

Study ID Number: 5179

ClinicalTrials.gov Identifier: NCT00348023

Health Authority: United States: Institutional Review Board