Travoprost/Brinzolamide Fixed Combination Versus Travatan and Versus AZOPT

This study has been terminated.
(Project Cancelled)
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00767494
First received: October 3, 2008
Last updated: September 18, 2012
Last verified: July 2009
  Purpose

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 Blind (Subject, 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 ] [ Designated as safety issue: Yes ]

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

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
AZOPT AM and PM
Drug: Azopt
Eye Drop Suspension, 1 drop BID
Active Comparator: 4
TRAVATAN PM, Vehicle AM
Drug: Travatan
Eye Drop Solution, 1 drop BID

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00767494

Locations
Belgium
Brussels, Belgium
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00767494     History of Changes
Other Study ID Numbers: C-07-63
Study First Received: October 3, 2008
Last Updated: September 18, 2012
Health Authority: Austria: Agency for Health and Food Safety
Belgium: Federal Agency for Medicinal Products and Health Products

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

Additional relevant MeSH terms:
Hypertension
Glaucoma
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Travoprost
Brinzolamide
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014