Open-angle GlaucomaPhase 3NCT00862472
Safety and Efficacy Study of DuoTrav APS Versus DuoTrav
A Phase 3 study testing DuoTrav APS and DuoTrav in people with Open-angle Glaucoma and Ocular Hypertension, run by Alcon Research.
Trial summary
The purpose of the study is to demonstrate that the IOP-lowering efficacy of DuoTrav APS, dosed once-daily in the morning, is non-inferior to that of DuoTrav, dosed once-daily in the morning. 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 APS and DuoTrav
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2009to Jun 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
- Patients with open-angle glaucoma or ocular hypertension who would benefit from a fixed combination medication, in the opinion of the investigator and who are currently on a stable treatment of IOP-lowering medication
Who cannot join
- VA not worse than 0.60
- additional clinically relevant ocular or systemic conditions may be excluded
About this study
The purpose of the study is to demonstrate that the IOP-lowering efficacy of DuoTrav APS, dosed once-daily in the morning, is non-inferior to that of DuoTrav, dosed once-daily in the morning.
- Conditions
- Open-angle Glaucoma, Ocular Hypertension
- Being tested
- DuoTrav APS, DuoTrav
- Keywords
- open-angle glaucoma, ocular hypertension, open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component)
- 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.
DuoTrav APSDrug
DuoTrav APS QD AM
DuoTravDrug
DuoTrav QD AM
| Study group | Role | What they receive |
|---|---|---|
| DuoTrav APS | Experimental | DuoTrav APS QD AM Receives: Drug: DuoTrav APS |
| DuoTrav | Active comparator | DuoTrav QD AM Receives: Drug: DuoTrav |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Intraocular Pressure (IOP)
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionJun 2009
- Study completionJun 2009
Why it stopped: Management decision not to conduct an additional efficacy study.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 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
- NCT00862472
- Sponsor's protocol ID
- C-09-006
- Status last verified
- Jan 2012
- First submitted
- 16 Mar 2009
- Last updated
- 18 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Study of DuoTrav APS Versus DuoTrav
- ClinicalTrials.gov ID
- NCT00862472
- Acronym / sponsor ID
- C-09-006
- Conditions
- Open-angle Glaucoma, Ocular Hypertension
- Keywords
- open-angle glaucoma, ocular hypertension, open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Management decision not to conduct an additional efficacy study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 17 Mar 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.
The purpose of the study is to demonstrate that the IOP-lowering efficacy of DuoTrav APS, dosed once-daily in the morning, is non-inferior to that of DuoTrav, dosed once-daily in the morning.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DuoTrav APS | Experimental | Drug: DuoTrav APSDuoTrav APS QD AM |
| DuoTrav | Active comparator | Drug: DuoTravDuoTrav QD AM |
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 open-angle glaucoma or ocular hypertension who would benefit from a fixed combination medication, in the opinion of the investigator and who are currently on a stable treatment of IOP-lowering medication
Key exclusion criteria (2 listed)
- VA not worse than 0.60
- additional clinically relevant ocular or systemic conditions may be excluded
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 |
|---|---|---|
| DuoTrav APSDuoTrav APS QD AM | Drug | DuoTrav APS |
| DuoTravDuoTrav QD AM | Drug | DuoTrav |
Primary outcome
Mean Intraocular Pressure (IOP)
Time frame: 3 Months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DuoTrav APS and DuoTrav in people with Open-angle Glaucoma and Ocular Hypertension, 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 1 inclusion and 2 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: withdrawn, as of the sponsor's last update on 18 Jan 2012. 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 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 withdrawn before enrolling participants, so there are no results.
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 Intraocular Pressure (IOP) (time frame: 3 Months). 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 18 Jan 2012.