Travoprost/Brinzolamide Fixed Combination Versus Travatan and Versus AZOPT

Phase 3

Terminated

• Conditions: Glaucoma; Ocular Hypertension
• Interventions: Drug: Travoprost/Brinzolamide fixed combination; Drug: Azopt; Drug: Travatan

• Registration Number: NCT00767494
• Lead Sponsor: Alcon Research

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 in patients with open-angle glaucoma or ocular hypertension.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-10-03
• Study First Submitted QC: 2008-10-06
• Study First Posted: 2008-10-07
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Status Verified: 2009-07
• Last Update Submitted: 2012-09-18
• Last Update Posted: 2012-09-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Travoprost/Brinzolamide fixed combination	Travoprost/Brinzolamide AM, Vehicle PM
2	Travoprost/Brinzolamide fixed combination	Travoprost/Brinzolamide PM, Vehicle AM
3	Azopt	AZOPT AM and PM
4	Travatan	TRAVATAN PM, Vehicle AM

Primary Outcome Measures

Name	Time	Method
Mean IOP	9, 11, and 16:00 time points at Week 12

Secondary Outcome Measures

Name	Time	Method
Mean diurnal IOP at Week 12	results pooled across 9,11, and 16:00 time points