The primary objective of this study is to compare the safety and IOP-lowering efficacy of Travoprost/Timolol BAC-free to Travoprost/Timolol in patients with primary open-angle glaucoma or ocular hypertension as a global study which is conducted in the US (C-07-64) and Japan (C-08-08).

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment

Study Primary Completion Date: August 2010

Intervention(s) in this Clinical Trial

• Drug: Travoprost 0.004%/Timolol 0.5%
  • 1 drop in each eye, once daily (QD) at 9 AM (± 30 minutes) for six (6) weeks
• Drug: Travoprost 0.004%/Timolol 0.5% BAC-free
  • 1 drop in each eye, once daily (QD) at 9 AM (± 30 minutes) for six (6) weeks

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 2
  • Travoprost 0.004%/Timolol 0.5%
• Experimental: 1
  • Travoprost 0.004%/Timolol 0.5% BAC-free

Primary Measures

• Mean IOP
  • Time Frame: 9AM, 11AM, 4PM
    Safety Issue?: No

Secondary Measures

• Percent of patients with IOP < 18 mmHg or IOP percent reduction ≥ 30%
  • Time Frame: Baseline
    Safety Issue?: No

Inclusion Criteria:

• Patients 20 years of age or older of either sex or race diagnosed with primary open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component) or ocular hypertension.

Exclusion Criteria:

• History or current evidence of chronic or recurrent severe inflammatory eye disease, progressive retinal disease, unstable/uncontrolled cardiovascular, hepatic or renal disease, bronchial asthma, or severe chronic obstructive pulmonary disease

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Alcon Research

Overall Clinical Trial Officials and Contacts

Overall Contact: Yoichi Iwamoto  yoichi.iwamoto@alconlabs.com

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00760539

Study ID Number: C-08-08

ClinicalTrials.gov Identifier: NCT00760539

Health Authority: Japan: Pharmaceuticals and Medical Devices Agency