Travoprost/Brinzolamide Fixed Combination Versus Travatan and Versus AZOPT

Alcon

Status and phase: Terminated; Phase 3

Conditions: Glaucoma; Ocular Hypertension

Treatments: Drug: Travatan; Drug: Travoprost/Brinzolamide fixed combination; Drug: Azopt

Study type: Interventional

Funder types: Industry

Identifiers

NCT00767494

C-07-63

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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17 participants in 4 patient groups

1

Experimental group

Description:

Travoprost/Brinzolamide AM, Vehicle PM

Treatment:

Drug: Travoprost/Brinzolamide fixed combination

2

Experimental group

Description:

Travoprost/Brinzolamide PM, Vehicle AM

Treatment:

Drug: Travoprost/Brinzolamide fixed combination

3

Active Comparator group

Description:

AZOPT AM and PM

Treatment:

Drug: Azopt

4

Active Comparator group

Description:

TRAVATAN PM, Vehicle AM

Treatment:

Drug: Travatan