Open-angle GlaucomaPhase 4NCT00828906
DuoTrav® Eye Drops As Replacement Therapy Program
A Phase 4 study testing DuoTrav in people with Open-angle Glaucoma and Ocular Hypertension, run by Alcon Research at 1 site in China.
Trial summary
To evaluate the effectiveness of DuoTrav Eye Drops in gaining or maintaining control of target Intraocular Pressures (tIOP) in patients diagnosed with, and being treated for, open-angle glaucoma (OAG) or ocular hypertension (OH). 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?
- DuoTrav
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteChina
- Study dates
- Feb 2009to Nov 2009
- Phase
- Phase 4
- 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 with OAG or OH for whom single agent therapy provides insufficient intraocular pressure reduction
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the effectiveness of DuoTrav Eye Drops in gaining or maintaining control of target Intraocular Pressures (tIOP) in patients diagnosed with, and being treated for, open-angle glaucoma (OAG) or ocular hypertension (OH).
- Conditions
- Open-angle Glaucoma, Ocular Hypertension
- Being tested
- DuoTrav
- Keywords
- Glaucoma, IOP, DuoTrav
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuoTravDrug
DuoTrav Eye Drops
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | DuoTrav Receives: Drug: DuoTrav |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra Ocular Pressure
Measured: visit 1, Visits 2-3, Visits 6-8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2009 (estimated)
- Study startFeb 2009
- Primary completionNov 2009
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 128 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
- NCT00828906
- Sponsor's protocol ID
- DART-2
- Status last verified
- Jul 2012
- First submitted
- 23 Jan 2009
- Last updated
- 20 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DuoTrav® Eye Drops As Replacement Therapy Program
- ClinicalTrials.gov ID
- NCT00828906
- Acronym / sponsor ID
- DART-2
- Conditions
- Open-angle Glaucoma, Ocular Hypertension
- Keywords
- Glaucoma, IOP, DuoTrav
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Nov 2009 (actual)
- First posted
- 26 Jan 2009 (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.
To evaluate the effectiveness of DuoTrav Eye Drops in gaining or maintaining control of target Intraocular Pressures (tIOP) in patients diagnosed with, and being treated for, open-angle glaucoma (OAG) or ocular hypertension (OH).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: DuoTravDuoTrav |
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 with OAG or OH for whom single agent therapy provides insufficient intraocular pressure reduction
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| DuoTravDuoTrav Eye Drops | Drug | 1 |
Primary outcome
Intra Ocular Pressure
Time frame: visit 1, Visits 2-3, Visits 6-8
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 20 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 4 study testing DuoTrav in people with Open-angle Glaucoma and Ocular Hypertension, run by Alcon Research at 1 site in China.
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 20 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 China. 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 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?
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?
Intra Ocular Pressure (time frame: visit 1, Visits 2-3, Visits 6-8). 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 20 Sep 2012.