Travoprost/Brinzolamide Fixed Combination Versus Travatan and Versus AZOPT

Last updated: September 18, 2012
Sponsor: Alcon Research
Overall Status: Terminated

Phase

3

Condition

Glaucoma

Circulation Disorders

Ocular Hypertension

Treatment

N/A

Clinical Study ID

NCT00767494
C-07-63
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 5to 28 days prior to eligibility visit 1

Exclusion

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 theconduct 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 toremain 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 thatmay affect IOP

  • Therapy with another investigational agent within 30 days prior to the Screening Visit

Study Design

Total Participants: 17
Study Start date:
October 01, 2008
Estimated Completion Date:
February 28, 2009

Connect with a study center

  • Brussels,
    Belgium

    Site Not Available

  • Alcon Call Center for Trial Locations

    Fort Worth, Texas 76134
    United States

    Site Not Available

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