Travoprost/Brinzolamide Fixed Combination Versus Travatan and Versus AZOPT

Launched by ALCON RESEARCH · Oct 6, 2008

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility 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