Open-angle GlaucomaPhase 3NCT00465803
A Phase IIIb Study of DuoTrav to Treat Glaucoma or Ocular Hypertension
A Phase 3 study testing Travoprost 0.004%/timolol 0.5% ophthalmic solution, Travoprost ophthalmic solution, 0.004% and Timolol maleate ophthalmic solution, 0.5% in people with Open-angle Glaucoma and Ocular Hypertension, run by Alcon Research at 1 site in United States.
Trial summary
The purpose of this study is to assess patient compliance with DuoTrav versus concomitant administration of Timolol 0.5% plus TRAVATAN 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
- Open-angle Glaucoma, Ocular Hypertension
- What is being tested?
- Travoprost 0.004%/timolol 0.5% ophthalmic solution, Travoprost ophthalmic solution, 0.004% and Timolol maleate ophthalmic solution, 0.5%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Jan 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
- Adult patients with open-angle glaucoma or ocular hypertension;
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Visual acuity worse than 0.60;
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Compliance Study Comparing DuoTrav to TRAVATAN Plus Timolol Using the Dosing Aid
The purpose of this study is to assess patient compliance with DuoTrav versus concomitant administration of Timolol 0.5% plus TRAVATAN in patients with open-angle glaucoma or ocular hypertension.
- Conditions
- Open-angle Glaucoma, Ocular Hypertension
- Being tested
- Travoprost 0.004%/timolol 0.5% ophthalmic solution, Travoprost ophthalmic solution, 0.004%, Timolol maleate ophthalmic solution, 0.5%
- Keywords
- Open-angle glaucoma or ocular hypertension
- 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.
Travoprost 0.004%/timolol 0.5% ophthalmic solutionDrug
Also called DuoTrav
One drop in the study eye(s) once daily at either 8 AM or 8 PM for twelve months using the Dosing Aid
Travoprost ophthalmic solution, 0.004%Drug
Also called TRAVATAN
One drop in the study eye(s) once daily at 8 PM for twelve months using the Dosing Aid
Timolol maleate ophthalmic solution, 0.5%Drug
One drop in the study eye(s) once daily at 8 AM or twelve months using the Dosing Aid
| Study group | Role | What they receive |
|---|---|---|
| DuoTrav | Other | One drop in the study eye(s) once daily at either 8 AM or 8 PM for twelve months, as recorded by dosing aid Receives: Drug: Travoprost 0.004%/timolol 0.5% ophthalmic solution |
| Travatan/Timolol | Other | One drop Timolol in the study eye(s) once daily at 8 AM; one drop of Travatan in the study eye(s) once daily at 8 PM. Both products dosed for twelve months, as recorded by separate dosing aid for each product. Receives: Drug: Travoprost ophthalmic solution, 0.004%; Drug: Timolol maleate ophthalmic solution, 0.5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient compliance
Patient compliance will be measured with a dosing aid that records time and date of study drug administration
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2007 (estimated)
- Study startMar 2007
- Primary completionJan 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.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Theresa Landry, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00465803
- Sponsor's protocol ID
- C-06-21
- Status last verified
- May 2012
- First submitted
- 23 Apr 2007
- Last updated
- 24 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compliance Study Comparing DuoTrav to TRAVATAN Plus Timolol Using the Dosing Aid
- ClinicalTrials.gov ID
- NCT00465803
- Acronym / sponsor ID
- C-06-21
- Conditions
- Open-angle Glaucoma, Ocular Hypertension
- Keywords
- Open-angle glaucoma or ocular hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Jan 2009 (actual)
- First posted
- 25 Apr 2007 (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 this study is to assess patient compliance with DuoTrav versus concomitant administration of Timolol 0.5% plus TRAVATAN in patients with open-angle glaucoma or ocular hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DuoTrav | Other | Drug: Travoprost 0.004%/timolol 0.5% ophthalmic solutionOne drop in the study eye(s) once daily at either 8 AM or 8 PM for twelve months, as recorded by dosing aid |
| Travatan/Timolol | Other | Drug: Travoprost ophthalmic solution, 0.004%, Drug: Timolol maleate ophthalmic solution, 0.5%One drop Timolol in the study eye(s) once daily at 8 AM; one drop of Travatan in the study eye(s) once daily at 8 PM. Both products dosed for twelve months, as recorded by separate dosing aid for each product. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients with open-angle glaucoma or ocular hypertension;
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (2 listed)
- Visual acuity worse than 0.60;
- Other protocol-defined exclusion criteria may apply.
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%/timolol 0.5% ophthalmic solutionAlso: DuoTravOne drop in the study eye(s) once daily at either 8 AM or 8 PM for twelve months using the Dosing Aid | Drug | DuoTrav |
| Travoprost ophthalmic solution, 0.004%Also: TRAVATANOne drop in the study eye(s) once daily at 8 PM for twelve months using the Dosing Aid | Drug | Travatan/Timolol |
| Timolol maleate ophthalmic solution, 0.5%One drop in the study eye(s) once daily at 8 AM or twelve months using the Dosing Aid | Drug | Travatan/Timolol |
Primary outcome
Patient compliance
Time frame: 12 months
Patient compliance will be measured with a dosing aid that records time and date of study drug administration
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 24 Jul 2014.
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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.
Theresa Landry study director
Alcon Research
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 0.004%/timolol 0.5% ophthalmic solution, Travoprost ophthalmic solution, 0.004% and Timolol maleate ophthalmic solution, 0.5% in people with Open-angle Glaucoma and Ocular Hypertension, run by Alcon Research at 1 site in United States.
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 2 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: finished, as of the sponsor's last update on 24 Jul 2014. 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 United States. 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 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?
Patient compliance (time frame: 12 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 24 Jul 2014.