Travoprost/Brinzolamide Fixed Combination Versus Travatan and Versus AZOPT

NCT00767494 | Terminated Phase 3

• 1 other identifier: C-07-63
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma; Ocular Hypertension

Keywords

OAG; OH; Open-angle glaucoma or ocular hypertension

Outcome Measures

Primary Outcomes (1)

• Mean IOP

  9, 11, and 16:00 time points at Week 12

Secondary Outcomes (1)

• Mean diurnal IOP at Week 12

  results pooled across 9,11, and 16:00 time points

Study Arms (4)

1

EXPERIMENTAL

Travoprost/Brinzolamide AM, Vehicle PM

Drug: Travoprost/Brinzolamide fixed combination

2

EXPERIMENTAL

Travoprost/Brinzolamide PM, Vehicle AM

Drug: Travoprost/Brinzolamide fixed combination

3

ACTIVE COMPARATOR

AZOPT AM and PM

Drug: Azopt

4

ACTIVE COMPARATOR

TRAVATAN PM, Vehicle AM

Drug: Travatan

Interventions

Travoprost/Brinzolamide fixed combination DRUG

Eye Drops, suspension once daily

1; 2

Azopt DRUG

Eye Drop Suspension, 1 drop BID

3

Travatan DRUG

Eye Drop Solution, 1 drop BID

4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• and 36 mmHg at 9AM
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Unknown Facility

Brussels, Belgium

Location

MeSH Terms

Conditions

Glaucoma; Ocular Hypertension; Glaucoma, Open-Angle

Interventions

Travoprost; brinzolamide

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Cloprostenol; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2008
• First Posted: October 7, 2008
• Study Start: October 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: September 19, 2012

Record last verified: 2009-07

Locations

BE (1)