Open-angle GlaucomaPhase 2NCT00527501
IOP Lowering Efficacy of Travoprost/Brinzolamide Fixed Combination Ophthalmic Suspension in Patients With Open-Angle Glaucoma or Ocular Hypertension
A Phase 2 study testing Travoprost/brinzolamide in people with Open-angle Glaucoma and Ocular Hypertension, run by Alcon Research at 1 site in United States.
Trial summary
The purpose of this study is to compare the safety and IOP-lowering efficacy of a fixed combination of Travoprost/Brinzolamide Ophthalmuc Suspension dosed BID and QD, to TRAVATAN dosed QD and a Vehicle dosed BID in patients with open-angle glaucoma or ocular hypertension. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open-angle Glaucoma, Ocular Hypertension
- What is being tested?
- Travoprost/brinzolamide
- How many people
- 136 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Dec 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 years of age or older of either sex and any race with diagnosed open-angle glaucoma or confirmed ocular hypertension
Who cannot join
- Age (Under 18)
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare the safety and IOP-lowering efficacy of a fixed combination of Travoprost/Brinzolamide Ophthalmuc Suspension dosed BID and QD, to TRAVATAN dosed QD and a Vehicle dosed BID in patients with open-angle glaucoma or ocular hypertension.
- Conditions
- Open-angle Glaucoma, Ocular Hypertension
- Being tested
- Travoprost/brinzolamide
- Keywords
- Open-angle glaucoma, ocular hypertension
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Travoprost/brinzolamideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean IOP
Measured: Time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2007 (estimated)
- Study startAug 2007
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open-angle GlaucomaStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Theresa Landry, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00527501
- Sponsor's protocol ID
- C-07-07
- Status last verified
- Feb 2008
- First submitted
- 10 Sep 2007
- Last updated
- 16 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IOP Lowering Efficacy of Travoprost/Brinzolamide Fixed Combination Ophthalmic Suspension in Patients With Open-Angle Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT00527501
- Acronym / sponsor ID
- C-07-07
- Conditions
- Open-angle Glaucoma, Ocular Hypertension
- Keywords
- Open-angle glaucoma, ocular hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 11 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the safety and IOP-lowering efficacy of a fixed combination of Travoprost/Brinzolamide Ophthalmuc Suspension dosed BID and QD, to TRAVATAN dosed QD and a Vehicle dosed BID in patients with open-angle glaucoma or ocular hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients 18 years of age or older of either sex and any race with diagnosed open-angle glaucoma or confirmed ocular hypertension
Key exclusion criteria (1 listed)
- Age (Under 18)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Travoprost/brinzolamide | Drug | – |
Primary outcome
Mean IOP
Time frame: Time
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theresa Landry study director
Alcon Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Travoprost/brinzolamide in people with Open-angle Glaucoma and Ocular Hypertension, run by Alcon Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean IOP (time frame: Time). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2012.