Travoprost/Brinzolamide Fixed Combination Versus Travatan and Versus AZOPT

Glaucoma Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00767494
• Other study ID #: C-07-63
• Status: Terminated
• Phase: Phase 3
• First received: October 3, 2008
• Last updated: September 18, 2012
• Start date: October 2008
• Est. completion date: February 2009

Study information

• Verified date: July 2009
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food SafetyBelgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Ocular Hypertension

Intervention

Drug:
• Travoprost/Brinzolamide fixed combination
Eye Drops, suspension once daily
• Azopt
Eye Drop Suspension, 1 drop BID
• Travatan
Eye Drop Solution, 1 drop BID

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean IOP		9, 11, and 16:00 time points at Week 12	Yes
Secondary	Mean diurnal IOP at Week 12		results pooled across 9,11, and 16:00 time points	Yes