ComplianceNCT00333463
Compliance With Once Daily Glaucoma Medication
An observational study of Compliance, run by Alcon Research at 1 site in United States.
Trial summary
A study to examine patient compliance with once daily glaucoma medication Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Compliance
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 700 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Sep 2007
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Primary open angle glaucoma or ocular hypertension patients
Who may be able to join
- Primary open angle glaucoma or ocular hypertension patients
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
A study to examine patient compliance with once daily glaucoma medication
- Conditions
- Compliance
- Being tested
- Intervention
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
The intervention group watched an educational video, reviewed current barriers to drop-taking and possible solutions with a study coordinator, received regular phone call reminders, and had audible and visible reminders activated on their DA devices.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | The intervention group watched an educational video, reviewed current barriers to drop-taking and possible solutions with a study coordinator, received regular phone call reminders, and had audible and visible reminders activated on their DA devices. Receives: Behavioral: Intervention | |
| Non-Intervention Group | The control group was told to take drops as prescribed and received no additional intervention. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2006 (estimated)
- Study startJun 2006
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ComplianceStudies 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
- Observational
- Time perspective
- Retrospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Johns Hopkins University, University of Pennsylvania
- Responsible party
- Sponsor
- Investigators
- David Friedman, MD, Study director, Study Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00333463
- Sponsor's protocol ID
- CMS-06-03
- Status last verified
- Mar 2010
- First submitted
- 1 Jun 2006
- Last updated
- 18 Nov 2016
- Results posted
- No
Publications
Okeke CO, Quigley HA, Jampel HD, Ying GS, Plyler RJ, Jiang Y, Friedman DS. Adherence with topical glaucoma medication monitored electronically the Travatan Dosing Aid study. Ophthalmology. 2009 Feb;116(2):191-9. doi: 10.1016/j.ophtha.2008.09.004. Epub 2008 Dec 12.
PubMed 19084273
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compliance With Once Daily Glaucoma Medication
- ClinicalTrials.gov ID
- NCT00333463
- Acronym / sponsor ID
- CMS-06-03
- Conditions
- Compliance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Collaborators
- Johns Hopkins University, University of Pennsylvania
- Study start
- Jun 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 5 Jun 2006 (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.
A study to examine patient compliance with once daily glaucoma medication
Study design
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | – | Behavioral: InterventionThe intervention group watched an educational video, reviewed current barriers to drop-taking and possible solutions with a study coordinator, received regular phone call reminders, and had audible and visible reminders activated on their DA devices. |
| Non-Intervention Group | – | –The control group was told to take drops as prescribed and received no additional intervention. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Primary open angle glaucoma or ocular hypertension patients
Key inclusion criteria (1 listed)
- Primary open angle glaucoma or ocular hypertension patients
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 |
|---|---|---|
| InterventionThe intervention group watched an educational video, reviewed current barriers to drop-taking and possible solutions with a study coordinator, received regular phone call reminders, and had audible and visible reminders activated on their DA devices. | Behavioural | Intervention group |
Primary outcome
Not reported in the source record.
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 18 Nov 2016.
- Results publication: PubMed 19084273Okeke CO, Quigley HA, Jampel HD, Ying GS, Plyler RJ, Jiang Y, Friedman DS. Adherence with topical glaucoma medication monitored electronically the Travatan Dosing Aid study. Ophthalmology. 2009 Feb;116(2):191-9. doi: 10.1016/j.ophtha.2008.09.004. Epub 2008 Dec 12.
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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.
David Friedman, MD study director
Study Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Compliance, 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 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 18 Nov 2016. 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.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00333463, which also lists 1 linked publication.
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 Nov 2016.