- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00767494
Travoprost/Brinzolamide Fixed Combination Versus Travatan and Versus AZOPT
September 18, 2012 updated by: Alcon Research
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
17
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Brussels, Belgium
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Travoprost/Brinzolamide AM, Vehicle PM
|
Eye Drops, suspension once daily
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Experimental: 2
Travoprost/Brinzolamide PM, Vehicle AM
|
Eye Drops, suspension once daily
|
Active Comparator: 3
AZOPT AM and PM
|
Eye Drop Suspension, 1 drop BID
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Active Comparator: 4
TRAVATAN PM, Vehicle AM
|
Eye Drop Solution, 1 drop BID
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean IOP
Time Frame: 9, 11, and 16:00 time points at Week 12
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9, 11, and 16:00 time points at Week 12
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean diurnal IOP at Week 12
Time Frame: results pooled across 9,11, and 16:00 time points
|
results pooled across 9,11, and 16:00 time points
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2008
Primary Completion (Actual)
February 1, 2009
Study Completion (Actual)
February 1, 2009
Study Registration Dates
First Submitted
October 3, 2008
First Submitted That Met QC Criteria
October 6, 2008
First Posted (Estimate)
October 7, 2008
Study Record Updates
Last Update Posted (Estimate)
September 19, 2012
Last Update Submitted That Met QC Criteria
September 18, 2012
Last Verified
July 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- C-07-63
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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