Intraocular PressurePhase 4NCT00758342
Azopt (Brinzolamide 1.0%) Plus Travatan (Travoprost 0.004%) in Treating Patients With Chronic Angle-Closure Glaucoma (CACG)
A Phase 4 study testing Travoprost 0.004% + Brinzolamide 1.0% and Travoprost 0.004% + Tears Natural in people with Intraocular Pressure, run by Alcon Research.
Trial summary
To evaluate the IOP (Intraocular Pressure) lowering efficacy and safety of Brinzolamide 1.0% (Azopt), dosed twice daily as adjunctive therapy in patients treated with Travoprost 0.004% (Travatan) once daily. The study is double masked. The patients will receive either treatment for 12 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intraocular Pressure
- What is being tested?
- Travoprost 0.004% + Brinzolamide 1.0% and Travoprost 0.004% + Tears Natural
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- May 2006to Mar 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years;
- CACG (Chronic Angle Closure Glaucoma) ≥ 1eye
- have been treated with PGA (prostaglandin analogues) once daily ≥ 2 weeks prior to the screening visit and IOP=19-32 mmHg (millimeters mercury) in at least one eye and ≤ 32 mmHg in both eyes
- clinical stability of VA (Visual Acuity) and optic nerve throughout the study
Who cannot join
- Abnormality restricts exam of the fundus or anderior chamber
- conjunctivitis, keratitis or uveitis
- unable to be discontinued from using all ocular hypotensive medication(s) except Travatan (Travoprost 0.004%) and/or Azopt (Brinzolamide 1.0%) for 12days-4weeks
- ocular surgery prior to the study
About this study
Official title: A Double-Masked, Parallel-Group, Efficacy and Safety Study of Brinzolamide 1.0% (AZOPT) as Adjunctive Therapy to Travoprost 0.004% (TRAVATAN) in Patients With Chronic Angle-Closure Glaucoma
To evaluate the IOP (Intraocular Pressure) lowering efficacy and safety of Brinzolamide 1.0% (Azopt), dosed twice daily as adjunctive therapy in patients treated with Travoprost 0.004% (Travatan) once daily. The study is double masked. The patients will receive either treatment for 12 weeks.
- Conditions
- Intraocular Pressure
- Being tested
- Travoprost 0.004% + Brinzolamide 1.0%, Travoprost 0.004% + Tears Natural
- Keywords
- IOP lowering efficacy and safety of Azopt plus Travatan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Travoprost 0.004% + Brinzolamide 1.0%Drug
Travoprost 0.004% (once daily) + Brinzolamide 1.0% (twice daily)
Travoprost 0.004% + Tears NaturalDrug
Travoprost 0.004% (once daily) + Tears Naturale (twice daily)
| Study group | Role | What they receive |
|---|---|---|
| Travoprost 0.004% + Brinzolamide 1.0% | Experimental | Travoprost 0.004% (once daily) + Brinzolamide 1.0% (twice daily) Receives: Drug: Travoprost 0.004% + Brinzolamide 1.0% |
| Travoprost 0.004% + Tears Natural | Active comparator | Travoprost 0.004% (once daily) + Tears Naturale (twice daily) Receives: Drug: Travoprost 0.004% + Tears Natural |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean IOP (Intraocular Pressure)
Measured: Screening: Week 12; (At 9 am and 4 pm time points)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2008 (estimated)
- Study startMay 2006
- Primary completionMar 2008
- Study completionMar 2008
Why it stopped: difficulty of enrolling patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Intraocular PressureStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 37 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
- NCT00758342
- Sponsor's protocol ID
- MS-06-01
- Status last verified
- Feb 2010
- First submitted
- 23 Sep 2008
- Last updated
- 5 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Masked, Parallel-Group, Efficacy and Safety Study of Brinzolamide 1.0% (AZOPT) as Adjunctive Therapy to Travoprost 0.004% (TRAVATAN) in Patients With Chronic Angle-Closure Glaucoma
- ClinicalTrials.gov ID
- NCT00758342
- Acronym / sponsor ID
- MS-06-01
- Conditions
- Intraocular Pressure
- Keywords
- IOP lowering efficacy and safety of Azopt plus Travatan
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulty of enrolling patients
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 25 Sep 2008 (estimated)
- Results
- Posted 5 Feb 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the IOP (Intraocular Pressure) lowering efficacy and safety of Brinzolamide 1.0% (Azopt), dosed twice daily as adjunctive therapy in patients treated with Travoprost 0.004% (Travatan) once daily. The study is double masked. The patients will receive either treatment for 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Travoprost 0.004% + Brinzolamide 1.0% | Experimental | Drug: Travoprost 0.004% + Brinzolamide 1.0%Travoprost 0.004% (once daily) + Brinzolamide 1.0% (twice daily) |
| Travoprost 0.004% + Tears Natural | Active comparator | Drug: Travoprost 0.004% + Tears NaturalTravoprost 0.004% (once daily) + Tears Naturale (twice daily) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 18 years;
- CACG (Chronic Angle Closure Glaucoma) ≥ 1eye
- have been treated with PGA (prostaglandin analogues) once daily ≥ 2 weeks prior to the screening visit and IOP=19-32 mmHg (millimeters mercury) in at least one eye and ≤ 32 mmHg in both eyes
- clinical stability of VA (Visual Acuity) and optic nerve throughout the study
Key exclusion criteria (4 listed)
- Abnormality restricts exam of the fundus or anderior chamber
- conjunctivitis, keratitis or uveitis
- unable to be discontinued from using all ocular hypotensive medication(s) except Travatan (Travoprost 0.004%) and/or Azopt (Brinzolamide 1.0%) for 12days-4weeks
- ocular surgery prior to the study
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 0.004% + Brinzolamide 1.0%Travoprost 0.004% (once daily) + Brinzolamide 1.0% (twice daily) | Drug | Travoprost 0.004% + Brinzolamide 1.0% |
| Travoprost 0.004% + Tears NaturalTravoprost 0.004% (once daily) + Tears Naturale (twice daily) | Drug | Travoprost 0.004% + Tears Natural |
Primary outcome
Mean IOP (Intraocular Pressure)
Time frame: Screening: Week 12; (At 9 am and 4 pm time points)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Travoprost 0.004% + Brinzolamide 1.0% and Travoprost 0.004% + Tears Natural in people with Intraocular Pressure, run by Alcon Research.
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 4 inclusion and 4 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 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Feb 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 (Intraocular Pressure) (time frame: Screening: Week 12; (At 9 am and 4 pm time points)). 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 5 Dec 2023.