GlaucomaXal-EaseNCT00573638
Effects of Xal-Ease on Patient Compliance With Xalatan
A study testing Xal-Ease device to be used with Xalatan eye drops in people with Glaucoma, run by Augusta University at 1 site in United States.
Trial summary
The study hypothesis is that the Xal-Ease with increase patient compliance with XALATAN Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Glaucoma
- What is being tested?
- Xal-Ease device to be used with Xalatan eye drops
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2005to Dec 2009
- Phase
- Interventional
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 40 to 80 years old
- Diagnosis warranting treatment with Xalatan eye drops.
- ambulatory and well functioning
Who cannot join
- non-ambulatory
- less than 40 or greater than 80 years old
- Not using Xalatan eye drops
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Medical College of Georgia Health Inc
Augusta, Georgia, 30912
About this study
Official title: The Effects of the Xal-Ease Delivery Aid Device on Patient Compliance With Xalatan Eye Drops
The study hypothesis is that the Xal-Ease with increase patient compliance with XALATAN
- Conditions
- Glaucoma
- Being tested
- Xal-Ease device to be used with Xalatan eye drops
- Keywords
- glaucoma, compliance, eye drops, deliver aid, Patients could range anywhere from 40 to 80 years old, Patients must have diagnosis requiring treatment with Xalatan., Patients will be male or female and from any racial/ethnic background.
- Medical subject headings
- Glaucoma, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xal-Ease device to be used with Xalatan eye dropsDevice
This intervention is a drop instillation guide to be used in conjunction with the FDA approved Xalatan eye drop.
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure is compliance with the medication XALATAN using and not using the Xal-Ease delivery aid for their glaucoma treatment.
Measured: six months
Secondary outcomes (2)
To determine if any of the other factors mentioned in the survey affect compliance to their medical regimen
Measured: six months
To see whether or not the Xal-Ease device helps patients conserve medication. ie - aids in drops not distilled in the eye.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2007 (estimated)
- Study startFeb 2005
- Study completionDec 2009 (estimated)
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Investigators
- Christian D. Nilson, MD, Principal investigator, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00573638
- Sponsor's protocol ID
- 05-02-266
- Other IDs
- Guarantor or CPI # 002533552
- Acronym
- Xal-Ease
- Status last verified
- Aug 2008
- First submitted
- 7 Dec 2007
- Last updated
- 8 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of the Xal-Ease Delivery Aid Device on Patient Compliance With Xalatan Eye Drops
- ClinicalTrials.gov ID
- NCT00573638
- Acronym / sponsor ID
- Xal-Ease / 05-02-266
- Conditions
- Glaucoma
- Keywords
- glaucoma, compliance, eye drops, deliver aid, Patients could range anywhere from 40 to 80 years old, Patients must have diagnosis requiring treatment with Xalatan., Patients will be male or female and from any racial/ethnic background.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Feb 2005
- Study completion
- Dec 2009 (estimated)
- First posted
- 14 Dec 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 study hypothesis is that the Xal-Ease with increase patient compliance with XALATAN
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 40 to 80 years old
- Diagnosis warranting treatment with Xalatan eye drops.
- ambulatory and well functioning
Key exclusion criteria (3 listed)
- non-ambulatory
- less than 40 or greater than 80 years old
- Not using Xalatan eye drops
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 |
|---|---|---|
| Xal-Ease device to be used with Xalatan eye dropsThis intervention is a drop instillation guide to be used in conjunction with the FDA approved Xalatan eye drop. | Device | – |
Primary outcome
The primary outcome measure is compliance with the medication XALATAN using and not using the Xal-Ease delivery aid for their glaucoma treatment.
Time frame: six months
2 secondary outcomes
To determine if any of the other factors mentioned in the survey affect compliance to their medical regimen
Time frame: six months
To see whether or not the Xal-Ease device helps patients conserve medication. ie - aids in drops not distilled in the eye.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2008.
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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.
Christian D. Nilson, MD principal investigator
Augusta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xal-Ease device to be used with Xalatan eye drops in people with Glaucoma, run by Augusta University 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 3 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: status not confirmed, as of the sponsor's last update on 8 Aug 2008. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian D. Nilson, MD (706-721-1150, cnilson@mail.mcg.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measure is compliance with the medication XALATAN using and not using the Xal-Ease delivery aid for their glaucoma treatment. (time frame: six 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 8 Aug 2008.