GlaucomaPhase 3NCT00767494
Travoprost/Brinzolamide Fixed Combination Versus Travatan and Versus AZOPT
A Phase 3 study testing Travoprost/Brinzolamide fixed combination, Azopt and Travatan in people with Glaucoma and Ocular Hypertension, run by Alcon Research at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Ocular Hypertension
- What is being tested?
- Travoprost/Brinzolamide fixed combination, Azopt and Travatan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2008to Feb 2009
- Phase
- Phase 3
- 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
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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)
Show all 19Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Travoprost/Brinzolamide fixed combination, Azopt, Travatan
- Keywords
- OAG, OH, Open-angle glaucoma or ocular hypertension
- Medical subject headings
- Glaucoma, Ocular Hypertension, Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Travoprost/Brinzolamide fixed combinationDrug
Eye Drops, suspension once daily
AzoptDrug
Eye Drop Suspension, 1 drop BID
TravatanDrug
Eye Drop Solution, 1 drop BID
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Travoprost/Brinzolamide AM, Vehicle PM Receives: Drug: Travoprost/Brinzolamide fixed combination |
| 2 | Experimental | Travoprost/Brinzolamide PM, Vehicle AM Receives: Drug: Travoprost/Brinzolamide fixed combination |
| 3 | Active comparator | AZOPT AM and PM Receives: Drug: Azopt |
| 4 | Active comparator | TRAVATAN PM, Vehicle AM Receives: Drug: Travatan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean IOP
Measured: 9, 11, and 16:00 time points at Week 12
Secondary outcomes (1)
Mean diurnal IOP at Week 12
Measured: results pooled across 9,11, and 16:00 time points
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionFeb 2009
- Study completionFeb 2009
Why it stopped: Project Cancelled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00767494
- Sponsor's protocol ID
- C-07-63
- Status last verified
- Jul 2009
- First submitted
- 3 Oct 2008
- Last updated
- 19 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Travoprost/Brinzolamide Fixed Combination Versus Travatan and Versus AZOPT
- ClinicalTrials.gov ID
- NCT00767494
- Acronym / sponsor ID
- C-07-63
- Conditions
- Glaucoma, Ocular Hypertension
- Keywords
- OAG, OH, Open-angle glaucoma or ocular hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Project Cancelled
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 7 Oct 2008 (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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Travoprost/Brinzolamide fixed combinationTravoprost/Brinzolamide AM, Vehicle PM |
| 2 | Experimental | Drug: Travoprost/Brinzolamide fixed combinationTravoprost/Brinzolamide PM, Vehicle AM |
| 3 | Active comparator | Drug: AzoptAZOPT AM and PM |
| 4 | Active comparator | Drug: TravatanTRAVATAN PM, Vehicle AM |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (19 listed)
- 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
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 fixed combinationEye Drops, suspension once daily | Drug | 1, 2 |
| AzoptEye Drop Suspension, 1 drop BID | Drug | 3 |
| TravatanEye Drop Solution, 1 drop BID | Drug | 4 |
Primary outcome
Mean IOP
Time frame: 9, 11, and 16:00 time points at Week 12
1 secondary outcome
Mean diurnal IOP at Week 12
Time frame: results pooled across 9,11, and 16:00 time points
Results and safety
The study was stopped early (reason given: Project Cancelled). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Travoprost/Brinzolamide fixed combination, Azopt and Travatan in people with Glaucoma and Ocular Hypertension, run by Alcon Research at 1 site in Belgium.
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 9 inclusion and 19 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: stopped early, as of the sponsor's last update on 19 Sep 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 Belgium. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: Project Cancelled). Results are not available in the source record.
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: 9, 11, and 16:00 time points at Week 12). 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 19 Sep 2012.