The purpose of this study is to demonstrate equivalent safety and IOP-lowering effectiveness of two Travoprost/Timolol combination products in patients diagnosed with open-angle glaucoma or ocular hypertension

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment

Study Primary Completion Date: May 2009

Intervention(s) in this Clinical Trial

• Drug: Travoprost/Timolol Combination
  • Solution

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Travoprost/Timolol Combination
• Active Comparator: 2
  • Travoprost/Timolol Combination

Primary Measures

• Mean IOP combined across all visits and time points
  • Time Frame: From baseline
    Safety Issue?: Yes

Secondary Measures

• Percentage of patients with IOP<18 mmHg or IOP percent reduction of > pr = to 30%
  • Time Frame: From baseline
    Safety Issue?: Yes

Inclusion Criteria:

• Mean IOP in at least one eye, the same eye(s):22-36 mmHg at 9 AM on eligibility visits 1 & 2 and 21-36 mmHg at 11 AM and 4 PM on Eligibility Visits 1 & 2; satisfy all informed consent requirements

Exclusion Criteria:

• Age related

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: Sally Valle 817-615-2453 

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00672997

Study ID Number: C-07-64

ClinicalTrials.gov Identifier: NCT00672997

Health Authority: United States: Food and Drug Administration