GlaucomaNCT00603005
Adherence Improvement in Glaucoma Patients
A study testing Use of TravAlert dosing aid with or without drop guider in people with Glaucoma, run by Maastricht University Medical Center at 14 sites in Netherlands.
Trial summary
The purpose of this study is to study the effect on intraocular pressure in glaucoma patients using the TravAlert dosing aid with or without the Eyot drop guider and with or without additional patient education. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Use of TravAlert dosing aid with or without drop guider
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 802 participants
- Where
- 14 sitesNetherlands
- Study dates
- Oct 2007to Jan 2010
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis glaucoma or ocular hypertension
- Treatment with travoprost or travoprost/timolol
Who cannot join
- High risk of side effects expected from travoprost or travoprost/timolol
- Absolute inability to administer eye drops
- Difficulty in reading or speaking Dutch
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Netherlands14 sites
Jeroen Bosch ziekenhuis
's-Hertogenbosch
Medisch centrum Alkmaar
Alkmaar
Wilhelmina ziekenhuis
Assen
Amphia ziekenhuis
Breda
Deventer ziekenhuis
Deventer
Catharina ziekenhuis
Eindhoven
Groene hart ziekenhuis
Gouda
ziekenhuis de Tjongerschans
Heerenveen
Atrium medisch centrum
Heerlen
Westfries gasthuis
Hoorn
University hospital
Maastricht
Canisius Wilhelmina ziekenhuis
Nijmegen
Erasmus medisch centrum
Rotterdam
Isala klinieken
Zwolle
About this study
The purpose of this study is to study the effect on intraocular pressure in glaucoma patients using the TravAlert dosing aid with or without the Eyot drop guider and with or without additional patient education.
- Conditions
- Glaucoma
- Being tested
- Use of TravAlert dosing aid with or without drop guider
- Keywords
- Glaucoma, Adherence
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of TravAlert dosing aid with or without drop guiderDevice
Each patient will use a dosing aid and/or drop guider for 6 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Device: Use of TravAlert dosing aid with or without drop guider |
| 2 | Experimental | Not described Receives: Device: Use of TravAlert dosing aid with or without drop guider |
| 3 | Experimental | Not described Receives: Device: Use of TravAlert dosing aid with or without drop guider |
| 4 | Experimental | Not described Receives: Device: Use of TravAlert dosing aid with or without drop guider |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure
Measured: 6 months
Secondary outcomes (1)
Information with regard to the use of eye drops from data generated by the TravAlert dosing system
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 posted28 Jan 2008 (estimated)
- Study startOct 2007
- Primary completionOct 2009
- Study completionJan 2010
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.
- More trials run by Maastricht University Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 802 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Investigators
- Helena J Beckers, MD/phD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00603005
- Sponsor's protocol ID
- MEC 07-1-015
- Other IDs
- CTCM-071015
- Status last verified
- Feb 2010
- First submitted
- 15 Jan 2008
- Last updated
- 24 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence Improvement in Glaucoma Patients
- ClinicalTrials.gov ID
- NCT00603005
- Acronym / sponsor ID
- MEC 07-1-015
- Conditions
- Glaucoma
- Keywords
- Glaucoma, Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 802 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- Oct 2007
- Primary completion
- Oct 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 28 Jan 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 purpose of this study is to study the effect on intraocular pressure in glaucoma patients using the TravAlert dosing aid with or without the Eyot drop guider and with or without additional patient education.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Use of TravAlert dosing aid with or without drop guider |
| 2 | Experimental | Device: Use of TravAlert dosing aid with or without drop guider |
| 3 | Experimental | Device: Use of TravAlert dosing aid with or without drop guider |
| 4 | Experimental | Device: Use of TravAlert dosing aid with or without drop guider |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis glaucoma or ocular hypertension
- Treatment with travoprost or travoprost/timolol
Key exclusion criteria (3 listed)
- High risk of side effects expected from travoprost or travoprost/timolol
- Absolute inability to administer eye drops
- Difficulty in reading or speaking Dutch
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 |
|---|---|---|
| Use of TravAlert dosing aid with or without drop guiderEach patient will use a dosing aid and/or drop guider for 6 months | Device | 1, 2, 3, 4 |
Primary outcome
Intraocular pressure
Time frame: 6 months
1 secondary outcome
Information with regard to the use of eye drops from data generated by the TravAlert dosing system
Time frame: 6 months
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 24 Feb 2010.
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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.
Helena J Beckers, MD/phD principal investigator
Maastricht University Medical Center
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of TravAlert dosing aid with or without drop guider in people with Glaucoma, run by Maastricht University Medical Center at 14 sites in Netherlands.
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 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: finished, as of the sponsor's last update on 24 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Netherlands. 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?
Intraocular pressure (time frame: 6 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 24 Feb 2010.