Status:
TERMINATED
Travoprost/Brinzolamide Fixed Combination Versus Travatan and Versus AZOPT
Lead Sponsor:
Alcon Research
Conditions:
Glaucoma
Ocular Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00767494
Start Date
October 1 2008
End Date
February 1 2009
Last Update
September 19 2012
Active Locations (1)
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1
Brussels, Belgium