GlaucomaPhase 3NCT00767481
1 Year Study Trav/Brinz QD Fixed Combination Versus COSOPT
A Phase 3 study testing Travoprost/Brinzolamide and Cosopt in people with Glaucoma and Ocular Hypertension, run by Alcon Research at 1 site in Mexico.
Trial summary
Parallel, Multi-Center, Double-masked, Active controlled, three arm study comparing the IOP lowering efficacy and safety over 12 months of morning or evening instillations of Travoprost/Brinzolamide vs. Cosopt dosed in the morning and evening 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 and Cosopt
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteMexico
- 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
- 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 9:00
- 21 and ≤ 36 mmHg at 11:00 and 16:00
Who cannot join
- Severe central visual field loss Angle Shaffer grade < 2 C/D ratio > 0.8 (horizontal or vertical measurement)
Trial locations and contacts
1 site in 1 country.
About this study
Parallel, Multi-Center, Double-masked, Active controlled, three arm study comparing the IOP lowering efficacy and safety over 12 months of morning or evening instillations of Travoprost/Brinzolamide vs. Cosopt dosed in the morning and evening in patients with open-angle glaucoma or ocular hypertension.
- Conditions
- Glaucoma, Ocular Hypertension
- Being tested
- Travoprost/Brinzolamide, Cosopt
- Keywords
- glaucoma, Patients with open-angle glaucoma or ocular hypertension
- Medical subject headings
- Glaucoma, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Travoprost/BrinzolamideDrug
Eye drop suspension, once daily
CosoptDrug
Eye drop solution, one drop BID
| Study group | Role | What they receive |
|---|---|---|
| Travoprost/Brinzolamide PM, Vehicle AM | Experimental | Travoprost/Brinzolamide PM, Vehicle AM Receives: Drug: Travoprost/Brinzolamide |
| Travoprost/Brinzolamide AM, Vehicle PM | Experimental | Travoprost/Brinzolamide AM, Vehicle PM Receives: Drug: Travoprost/Brinzolamide |
| Cosopt | Active comparator | Cosopt BID Receives: Drug: Cosopt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean IOP
Measured: 9:00,11:00, and 1600 time points at month 12
Secondary outcomes (1)
Percent change in IOP, IOP change from baseline, patients with IOP <18mmHg. BSCVA, Ocular signs, Dilated fundus, perimetry, pachymetry, cardiovascular parameters(pulse, BP and AEs at W2, W3, M6, M9 and M12.
Measured: All on therapy time points not included in primary efficacy
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.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00767481
- Sponsor's protocol ID
- C-08-16
- Other IDs
- 2008-002781-66, 2008
- Status last verified
- Nov 2011
- First submitted
- 3 Oct 2008
- Last updated
- 19 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 1 Year Study Trav/Brinz QD Fixed Combination Versus COSOPT
- ClinicalTrials.gov ID
- NCT00767481
- Acronym / sponsor ID
- C-08-16
- Conditions
- Glaucoma, Ocular Hypertension
- Keywords
- glaucoma, Patients with open-angle glaucoma or ocular hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Project Cancelled
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- 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.
Parallel, Multi-Center, Double-masked, Active controlled, three arm study comparing the IOP lowering efficacy and safety over 12 months of morning or evening instillations of Travoprost/Brinzolamide vs. Cosopt dosed in the morning and evening in patients with open-angle glaucoma or ocular hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Travoprost/Brinzolamide PM, Vehicle AM | Experimental | Drug: Travoprost/BrinzolamideTravoprost/Brinzolamide PM, Vehicle AM |
| Travoprost/Brinzolamide AM, Vehicle PM | Experimental | Drug: Travoprost/BrinzolamideTravoprost/Brinzolamide AM, Vehicle PM |
| Cosopt | Active comparator | Drug: CosoptCosopt BID |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- IOP at screening visit <18mmHg in at least one eye Mean IOP in same eye (at both eligibility 1 \&2 visits)
Key exclusion criteria (1 listed)
- Severe central visual field loss Angle Shaffer grade < 2 C/D ratio > 0.8 (horizontal or vertical measurement)
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/BrinzolamideEye drop suspension, once daily | Drug | Travoprost/Brinzolamide AM, Vehicle PM, Travoprost/Brinzolamide PM, Vehicle AM |
| CosoptEye drop solution, one drop BID | Drug | Cosopt |
Primary outcome
Mean IOP
Time frame: 9:00,11:00, and 1600 time points at month 12
1 secondary outcome
Percent change in IOP, IOP change from baseline, patients with IOP <18mmHg. BSCVA, Ocular signs, Dilated fundus, perimetry, pachymetry, cardiovascular parameters(pulse, BP and AEs at W2, W3, M6, M9 and M12.
Time frame: All on therapy time points not included in primary efficacy
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 Jul 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 and Cosopt in people with Glaucoma and Ocular Hypertension, run by Alcon Research at 1 site in Mexico.
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 3 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: stopped early, as of the sponsor's last update on 19 Jul 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 Mexico. 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: 9:00,11:00, and 1600 time points at month 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 Jul 2012.