The purpose of the study is to compare the IOP lowering efficacy of Travoprost/Brinzolamide dosed daily in the morning or evening, vs TRAVATAN dosed once daily in the evening, and vs.

AZOPT dosed BID in patients with open-angle glaucoma or ocular hypertension.

Study Type: Interventional

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

Study Primary Completion Date: March 2010

Intervention(s) in this Clinical Trial

• Drug: Travoprost/Brinzolamide fixed combination
  • Eye Drops, suspension once daily
• Drug: Azopt
  • Eye Drop Suspension, 1 drop BID
• Drug: Travatan
  • Eye Drop Solution, 1 drop BID

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Travoprost/Brinzolamide AM, Vehicle PM
• Experimental: 2
  • Travoprost/Brinzolamide PM, Vehicle AM
• Active Comparator: 3
  • AZOPT AM and PM
• Active Comparator: 4
  • TRAVATAN PM, Vehicle AM

Primary Measures

• Mean IOP
  • Time Frame: 9, 11, and 16:00 time points at Week 12
    Safety Issue?: Yes

Secondary Measures

• Mean diurnal IOP at Week 12
  • Time Frame: results pooled across 9,11, and 16:00 time points
    Safety Issue?: Yes

Inclusion Criteria:

• 18 YOA or older
• Either gender or any race
• OAG or OHT
• Currently on stable (at least 4 weeks) IOP lowering medication
• IOP at screening visit ≥ 18mmHg in at least one eye
• Mean IOP in same eye (at both eligibility 1&2 visits
• 24 and 36 mmHg at 9AM
• 21 and 36 mmHg at 11AM and 4PM
• Able to discontinue use of IOP lowering medication for a minimum wash out period of 5 to 28 days prior to eligibility visit 1

Exclusion Criteria:

• Related to disease condition being investigated (OAG or OHT) in either eye
• Severe central visual field loss
• Angle shaffer grade < 2
• C/D ratio >0.8(horizontal or vertical measurement)
• Related to ocular patient history or current ocular condition in either eye
• BSCVA worse than 55 ETDRS letters read (equivalent to approximately 20/80 Snellen or 0.25 decimal)
• Ocular infection or inflammation or laser surgery within the last 3 months
• Intraocular surgery or trauma with the last 6 months
• Any abnormality preventing reliable applanation tonometry
• History or chronic, recurrently or current severe inflammatory disease
• History of or current clinically significant or progressive retinal disease
• History of or current ocular pathology(including severe dry eye) that would affect the conduct of the study
• Related to systemic or ocular medication in either eye
• Allergy/hypersensitivity to study medications
• Unable to discontinue glucocorticoid at least 4 weeks prior to the study or unable to remain off these medications during the study period
• Use of oral CAIs during the study
• Recent use (<4 weeks prior to the study) of Aspirin (>1 gram)
• Less than 30 days stable dosing regimen of medications used on a chronic basis that may affect IOP
• Therapy with another investigational agent within 30 days prior to the Screening Visit

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 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: Alcon Call Center 1-888-451-3937 

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00767494

Study ID Number: C-07-63

ClinicalTrials.gov Identifier: NCT00767494

Health Authority: Austria: Agency for Health and Food Safety