GlaucomaPhase 4NCT00626067
Study of Patient Use and Perception of the Travatan Dosing Aid
A Phase 4 study testing Fully functional monitoring device, Partially functional monitoring device and Non-functional monitoring device in people with Glaucoma, run by Wills Eye.
Trial summary
The primary objective of this study is to determine the opinions of patients who are given the Travatan Compliance Monitoring Dispenser to use to dispense their Travatan glaucoma drops. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- What is being tested?
- Fully functional monitoring device, Partially functional monitoring device and Non-functional monitoring device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Sep 2006to Feb 2007
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Open angle glaucoma or ocular hypertension
- Presently using Travatan eye drops
Who cannot join
- Allergy to prostaglandin
About this study
Official title: Pilot Study of Patient Acceptance and Impact of the New Travatan™ Compliance Monitoring Dispenser (Travatan™ Dosing Aid)
The primary objective of this study is to determine the opinions of patients who are given the Travatan Compliance Monitoring Dispenser to use to dispense their Travatan glaucoma drops.
Read the detailed description
Patients enrolled in this study will use the new Travatan compliance monitoring dispenser for 6 weeks. Patients will be informed that some, but not all, patients' compliance will be monitored by the device. Patients are randomly assigned to one of three groups (proportionally in a 2/2/1 ratio):
- Fully functional Travatan compliance monitor
- Travatan compliance monitor with LCD display and alarms disabled, but compliance monitoring intact
- Travatan compliance monitor with LCD display, alarms and compliance monitor disabled.
At end of study, patients fill out questionnaire assessing
- Patient opinion regarding device: ease of use of new device; preference vs Travatan use without device, etc
- patient's belief as to whether their compliance was monitored or not
Rates of adherence are compared across groups and with regard to patients' reported beliefs as to whether they were monitored.
The design of this study should allow the clinicians to ethically monitor compliance in patients who do and do not believe that they are being monitored. The use of monitoring devices without a functioning display and alarm should lead to some patients believing that they are not being monitored. As patients are told at the outset that they may or may not be monitored, this should be an ethically acceptable design. However, the collected data will allow a preliminary assessment of the impact of the patients' beliefs as to whether they are being monitored on their actual compliance, and hence an additional potential value of the device.
- Conditions
- Glaucoma
- Being tested
- Fully functional monitoring device, Partially functional monitoring device, Non-functional monitoring device
- Keywords
- Travatan Dosing Aid, compliance monitoring dispenser
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fully functional monitoring deviceDevice
Pt received fully functional monitoring dispenser for use with their Travatan eye drops
Partially functional monitoring deviceDevice
Patient received a particually functional Travatan Compliance Monitoring Dispenser
Non-functional monitoring deviceDevice
Patient received a non functioning Travatan Compliance Monitoring Dispenser
| Study group | Role | What they receive |
|---|---|---|
| 1 Fully functional monitoring device | Active comparator | Fully functional monitoring device Receives: Device: Fully functional monitoring device |
| 2 Partially functional monitoring device | Active comparator | Partially functional monitoring device Receives: Device: Partially functional monitoring device |
| 3 Non-functional monitoring device | Sham comparator | Non-functional monitoring device Receives: Device: Non-functional monitoring device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess patients' opinions regarding new Travatan Compliance Monitoring Dispenser
Measured: 6 weeks
Secondary outcomes (1)
Pilot study of the impact of physician monitoring of compliance on patient compliance
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2008 (estimated)
- Study startSep 2006
- Primary completionFeb 2007
- Study completionFeb 2007
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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wills Eye
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Responsible party
- Principal investigator, Jonathon Myers, Wills Eye
- Investigators
- Jonathan S. Myers, MD, Principal investigator, Wills Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00626067
- Sponsor's protocol ID
- IRB #06-762E
- Other IDs
- CMS-06-09
- Status last verified
- Nov 2016
- First submitted
- 22 Jan 2008
- Last updated
- 10 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: A Manuscript has been accepted and published in Patient Preference and Adherence.
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Patient Acceptance and Impact of the New Travatan™ Compliance Monitoring Dispenser (Travatan™ Dosing Aid)
- ClinicalTrials.gov ID
- NCT00626067
- Acronym / sponsor ID
- IRB #06-762E
- Conditions
- Glaucoma
- Keywords
- Travatan Dosing Aid, compliance monitoring dispenser
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Wills EyeUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- Sep 2006
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 29 Feb 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.
The primary objective of this study is to determine the opinions of patients who are given the Travatan Compliance Monitoring Dispenser to use to dispense their Travatan glaucoma drops.
Detailed description
Patients enrolled in this study will use the new Travatan compliance monitoring dispenser for 6 weeks. Patients will be informed that some, but not all, patients' compliance will be monitored by the device. Patients are randomly assigned to one of three groups (proportionally in a 2/2/1 ratio):
- Fully functional Travatan compliance monitor
- Travatan compliance monitor with LCD display and alarms disabled, but compliance monitoring intact
- Travatan compliance monitor with LCD display, alarms and compliance monitor disabled.
At end of study, patients fill out questionnaire assessing
- Patient opinion regarding device: ease of use of new device; preference vs Travatan use without device, etc
- patient's belief as to whether their compliance was monitored or not
Rates of adherence are compared across groups and with regard to patients' reported beliefs as to whether they were monitored.
The design of this study should allow the clinicians to ethically monitor compliance in patients who do and do not believe that they are being monitored. The use of monitoring devices without a functioning display and alarm should lead to some patients believing that they are not being monitored. As patients are told at the outset that they may or may not be monitored, this should be an ethically acceptable design. However, the collected data will allow a preliminary assessment of the impact of the patients' beliefs as to whether they are being monitored on their actual compliance, and hence an additional potential value of the device.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 Fully functional monitoring device | Active comparator | Device: Fully functional monitoring deviceFully functional monitoring device |
| 2 Partially functional monitoring device | Active comparator | Device: Partially functional monitoring devicePartially functional monitoring device |
| 3 Non-functional monitoring device | Sham comparator | Device: Non-functional monitoring deviceNon-functional monitoring device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Open angle glaucoma or ocular hypertension
- Presently using Travatan eye drops
Key exclusion criteria (1 listed)
- Allergy to prostaglandin
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 |
|---|---|---|
| Fully functional monitoring devicePt received fully functional monitoring dispenser for use with their Travatan eye drops | Device | 1 Fully functional monitoring device |
| Partially functional monitoring devicePatient received a particually functional Travatan Compliance Monitoring Dispenser | Device | 2 Partially functional monitoring device |
| Non-functional monitoring devicePatient received a non functioning Travatan Compliance Monitoring Dispenser | Device | 3 Non-functional monitoring device |
Primary outcome
Assess patients' opinions regarding new Travatan Compliance Monitoring Dispenser
Time frame: 6 weeks
1 secondary outcome
Pilot study of the impact of physician monitoring of compliance on patient compliance
Time frame: 6 weeks
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 10 Nov 2016.
- Patient Preference and AdherenceLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. A Manuscript has been accepted and published in Patient Preference and Adherence.
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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.
Jonathan S. Myers, MD principal investigator
Wills Eye Institute
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fully functional monitoring device, Partially functional monitoring device and Non-functional monitoring device in people with Glaucoma, run by Wills Eye.
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 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 10 Nov 2016. 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. Some participants in this study may receive a placebo. 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?
Assess patients' opinions regarding new Travatan Compliance Monitoring Dispenser (time frame: 6 weeks). 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 10 Nov 2016; AzTrials last refreshed its copy on 7 Nov 2026.