Open Angle GlaucomaNCT01484392
Determinants of Compliance With Glaucoma Therapy
An observational study of Open Angle Glaucoma, run by Legacy Health System at 1 site in United States.
Trial summary
The purpose of this study is to determine which medical, demographic, and health belief factors are associated with glaucoma therapy compliance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open Angle Glaucoma
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Dec 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with open angle glaucoma.
Who may be able to join
- open angle glaucoma
- be well controlled on current medical therapy
- be using a prostaglandin analogue
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine which medical, demographic, and health belief factors are associated with glaucoma therapy compliance.
- Conditions
- Open Angle Glaucoma
- Keywords
- open angle glaucoma, compliance, adherence
- Medical subject headings
- Glaucoma, Open-Angle, Patient Compliance
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance with glaucoma medication at 1 month
Compliance is measured using the Travatan Dosing Aid, a device that records when patients administer their topical glaucoma medication.
Measured: 1 month after enrollment
Compliance with glaucoma medication at 3 months
Compliance is measured using the Travatan Dosing Aid, a device that records when patients administer their topical glaucoma medication.
Measured: 3 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2011 (estimated)
- Study startAug 2006
- Primary completionDec 2013
- Study completionDec 2013
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Legacy Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven L. Mansberger, Legacy Health System
- Investigators
- Steven L Mansberger, MD, MPH, Principal investigator, Legacy Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01484392
- Sponsor's protocol ID
- FWA00001280
- Status last verified
- Mar 2016
- First submitted
- 30 Nov 2011
- Last updated
- 9 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of Compliance With Glaucoma Therapy
- ClinicalTrials.gov ID
- NCT01484392
- Acronym / sponsor ID
- FWA00001280
- Conditions
- Open Angle Glaucoma
- Keywords
- open angle glaucoma, compliance, adherence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Legacy Health SystemUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 2 Dec 2011 (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 determine which medical, demographic, and health belief factors are associated with glaucoma therapy compliance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with open angle glaucoma.
Key inclusion criteria (3 listed)
- open angle glaucoma
- be well controlled on current medical therapy
- be using a prostaglandin analogue
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Compliance with glaucoma medication at 1 month
Time frame: 1 month after enrollment
Compliance is measured using the Travatan Dosing Aid, a device that records when patients administer their topical glaucoma medication.
Compliance with glaucoma medication at 3 months
Time frame: 3 months after enrollment
Compliance is measured using the Travatan Dosing Aid, a device that records when patients administer their topical glaucoma medication.
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 9 Mar 2016.
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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.
Steven L Mansberger, MD, MPH principal investigator
Legacy Health
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 Open Angle Glaucoma, run by Legacy Health System 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 3 inclusion and 0 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 9 Mar 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.
What does the primary outcome measure?
Compliance with glaucoma medication at 1 month (time frame: 1 month after enrollment). The study lists 2 primary outcomes in all. 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 9 Mar 2016.