GlaucomaNCT00750646
Observational Study of How Patients Take Eye Drops
An observational study of Glaucoma, run by Robin, Alan L., M.D. at 1 site in United States.
Trial summary
This study is interested in monitoring how patients take eye drops, both through video-recordings and adherence monitoring, as well as their perceptions about their eye medications; including the dosing schedules, instillation techniques and effect on their disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- What is being tested?
- MEMS cap
- Type of treatment
- Medical device
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Aug 2009
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects will be enrolled for a single site, private practice.
Who may be able to join
- >18 year old
- currently taking 1 or more hypotensive topical eye drops takes drops in the right eye for more than 6 months expect to continue drop use for the next 3 months
- subjects instill their own eye drops
- subject is able to take HVF tests
- subject will expect to complete the 3 months enrollment period
Who cannot join
- unable/unwilling to instill own medications
- eye drops are discontinued
- unable to take HVF test
- unable to complete follow-up
- investigators discontinue subject for safety reasons
- not using drops in left eye
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Glaucoma Specialists
Baltimore, Maryland, 21209
Colleen K Protzko, 410-377-2422, cprotzko@glaucomaexpert.com
Millie Brummett, 4103772422
About this study
Official title: The Relationship Between Glaucoma Medication Self-Efficacy, Outcome Expectations, Eye Drop Tech., Adherence and IOP.
This study is interested in monitoring how patients take eye drops, both through video-recordings and adherence monitoring, as well as their perceptions about their eye medications; including the dosing schedules, instillation techniques and effect on their disease.
- Conditions
- Glaucoma
- Being tested
- MEMS cap
- Keywords
- compliance, eye drop administration, MEMS, adherence
- 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.
MEMS capDevice
Also called MEMS
The Medication Event Monitoring System will be used to assess the level of subject adherence to recommended topical eye drop therapy.
| Study group | Role | What they receive |
|---|---|---|
| A | Subject's adherence to prescribed therapy will be monitored with an electronic compliance device. Receives: Device: MEMS cap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication adherence measured by MEMS caps
Measured: 3 months
Eye drop technique measured by video evaluation
Measured: 1 time observation
Secondary outcomes (3)
Medication adherence measured by self-report
Measured: 3 months
Severity of VF damage
Measured: 1 test date
Intraocular pressure readings
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionMar 2009 (estimated)
- Study completionAug 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Robin, Alan L., M.D.
- Collaborators
- Alcon Research
- Investigators
- Jennifer L Stone, OD, Principal investigator, Glaucoma ExpertsAlan L Robin, MD, Principal investigator, Glaucoma SpecialistsColleen K Protzko, Study director, Glaucoma Specialists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00750646
- Sponsor's protocol ID
- SI-08-54
- Status last verified
- Sep 2008
- First submitted
- 9 Sep 2008
- Last updated
- 10 Sep 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Glaucoma Medication Self-Efficacy, Outcome Expectations, Eye Drop Tech., Adherence and IOP.
- ClinicalTrials.gov ID
- NCT00750646
- Acronym / sponsor ID
- SI-08-54
- Conditions
- Glaucoma
- Keywords
- compliance, eye drop administration, MEMS, adherence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Robin, Alan L., M.D.
- Collaborators
- Alcon Research
- Study start
- Sep 2008
- Primary completion
- Mar 2009 (estimated)
- Study completion
- Aug 2009 (estimated)
- First posted
- 10 Sep 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.
This study is interested in monitoring how patients take eye drops, both through video-recordings and adherence monitoring, as well as their perceptions about their eye medications; including the dosing schedules, instillation techniques and effect on their disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | Device: MEMS capSubject's adherence to prescribed therapy will be monitored with an electronic compliance device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be enrolled for a single site, private practice.
Key inclusion criteria (5 listed)
- >18 year old
- currently taking 1 or more hypotensive topical eye drops takes drops in the right eye for more than 6 months expect to continue drop use for the next 3 months
- subjects instill their own eye drops
- subject is able to take HVF tests
- subject will expect to complete the 3 months enrollment period
Key exclusion criteria (6 listed)
- unable/unwilling to instill own medications
- eye drops are discontinued
- unable to take HVF test
- unable to complete follow-up
- investigators discontinue subject for safety reasons
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 |
|---|---|---|
| MEMS capAlso: MEMSThe Medication Event Monitoring System will be used to assess the level of subject adherence to recommended topical eye drop therapy. | Device | A |
Primary outcome
Medication adherence measured by MEMS caps
Time frame: 3 months
Eye drop technique measured by video evaluation
Time frame: 1 time observation
3 secondary outcomes
Medication adherence measured by self-report
Time frame: 3 months
Severity of VF damage
Time frame: 1 test date
Intraocular pressure readings
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 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.
Jennifer L Stone, OD principal investigator
Glaucoma Experts
Alan L Robin, MD principal investigator
Glaucoma Specialists
Colleen K Protzko study director
Glaucoma Specialists
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 Glaucoma, run by Robin, Alan L., M.D. 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 5 inclusion and 6 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 10 Sep 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 Jennifer L Stone, OD (410 377 2422, jstone@glacuomaexpert.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication adherence measured by MEMS caps (time frame: 3 months). 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 10 Sep 2008; AzTrials last refreshed its copy on 6 Nov 2026.