Travoprost/Brinzolamide Fixed Combination Versus Travatan and Versus AZOPT
NCT ID: NCT00767494
Last Updated: 2012-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
17 participants
INTERVENTIONAL
2008-10-31
2009-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
Travoprost/Brinzolamide AM, Vehicle PM
Travoprost/Brinzolamide fixed combination
Eye Drops, suspension once daily
2
Travoprost/Brinzolamide PM, Vehicle AM
Travoprost/Brinzolamide fixed combination
Eye Drops, suspension once daily
3
AZOPT AM and PM
Azopt
Eye Drop Suspension, 1 drop BID
4
TRAVATAN PM, Vehicle AM
Travatan
Eye Drop Solution, 1 drop BID
Interventions
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Travoprost/Brinzolamide fixed combination
Eye Drops, suspension once daily
Azopt
Eye Drop Suspension, 1 drop BID
Travatan
Eye Drop Solution, 1 drop BID
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Alcon Research
INDUSTRY
Responsible Party
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Locations
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Brussels, , Belgium
Countries
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Other Identifiers
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C-07-63
Identifier Type: -
Identifier Source: org_study_id