Open Angle GlaucomaNCT00362622
Determinants of Compliance With Glaucoma Therapy
An observational study of Open Angle Glaucoma, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
To determine the association between medical, demographic, socioeconomic, and therapeutic differences on compliance with topical glaucoma therapy using the Travalert device. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Open Angle Glaucoma
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Jan 2008
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Glaucoma patients.
To be eligible to participate in the study, patients had to be (1) 19 years or older; (2) have a diagnosis of open angle glaucoma (OAG) in 1 or both eyes or ocular hypertension; and (3) using a prostaglandin ocular hypotensive medication in 1 or both eyes.
The protocol excluded patients with uncontrolled IOP control, known contraindications to Travoprost, clinically significant systemic disease that would interfere with the study, participation in any other research study within 30 days, or change in systemic medications that may alter IOP within 30 days before recruitment.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
To determine the association between medical, demographic, socioeconomic, and therapeutic differences on compliance with topical glaucoma therapy using the Travalert device.
Read the detailed description
To determine the association between medical, demographic, socioeconomic, and therapeutic differences on compliance with topical glaucoma therapy using the Travalert device. All participants will have open angle glaucoma.
- Conditions
- Open Angle Glaucoma
- Keywords
- Travalert, open angle glaucoma
- Medical subject headings
- Glaucoma, Open-Angle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2006 (estimated)
- Study startOct 2005
- Study completionJan 2008
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 University of Alabama at BirminghamThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Responsible party
- Principal investigator, Christopher Girkin, MD, University of Alabama at Birmingham
- Investigators
- Christopher A Girkin, MD, Principal investigator, University of Alabama at BirminghamJason Swanner, MD, Principal investigator, University of Alabama at BirminghamMatthew Sapp, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00362622
- Sponsor's protocol ID
- X050826003
- Status last verified
- Aug 2012
- First submitted
- 9 Aug 2006
- Last updated
- 16 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of Compliance With Glaucoma Therapy
- ClinicalTrials.gov ID
- NCT00362622
- Acronym / sponsor ID
- X050826003
- Conditions
- Open Angle Glaucoma
- Keywords
- Travalert, open angle glaucoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- Oct 2005
- Study completion
- Jan 2008 (actual)
- First posted
- 10 Aug 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.
To determine the association between medical, demographic, socioeconomic, and therapeutic differences on compliance with topical glaucoma therapy using the Travalert device.
Detailed description
To determine the association between medical, demographic, socioeconomic, and therapeutic differences on compliance with topical glaucoma therapy using the Travalert device. All participants will have open angle glaucoma.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Glaucoma patients.
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
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 16 Aug 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.
Christopher A Girkin, MD principal investigator
University of Alabama at Birmingham
Jason Swanner, MD principal investigator
University of Alabama at Birmingham
Matthew Sapp, MD principal investigator
University of Alabama at Birmingham
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 University of Alabama at Birmingham 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?
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 16 Aug 2012. 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?
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 16 Aug 2012.