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Travoprost/Brinzolamide Fixed Combination Versus Travatan and Versus AZOPT

This study has been terminated.
(Project Cancelled)
Information provided by (Responsible Party):
Alcon Research Identifier:
First received: October 3, 2008
Last updated: September 18, 2012
Last verified: July 2009
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.

Condition Intervention Phase
Glaucoma Ocular Hypertension Drug: Travoprost/Brinzolamide fixed combination Drug: Azopt Drug: Travatan Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean IOP [ Time Frame: 9, 11, and 16:00 time points at Week 12 ]

Secondary Outcome Measures:
  • Mean diurnal IOP at Week 12 [ Time Frame: results pooled across 9,11, and 16:00 time points ]

Enrollment: 17
Study Start Date: October 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Travoprost/Brinzolamide AM, Vehicle PM
Drug: Travoprost/Brinzolamide fixed combination
Eye Drops, suspension once daily
Experimental: 2
Travoprost/Brinzolamide PM, Vehicle AM
Drug: Travoprost/Brinzolamide fixed combination
Eye Drops, suspension once daily
Active Comparator: 3
Drug: Azopt
Eye Drop Suspension, 1 drop BID
Active Comparator: 4
Drug: Travatan
Eye Drop Solution, 1 drop BID


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00767494

Brussels, Belgium
Sponsors and Collaborators
Alcon Research
  More Information

Responsible Party: Alcon Research Identifier: NCT00767494     History of Changes
Other Study ID Numbers: C-07-63
Study First Received: October 3, 2008
Last Updated: September 18, 2012

Keywords provided by Alcon Research:
Open-angle glaucoma or ocular hypertension

Additional relevant MeSH terms:
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Antihypertensive Agents
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on September 21, 2017