GlaucomaNCT01719809
An Evaluation of the Ability to Train Established Glaucoma Patients Who Have Difficulty in Drop Instillation
An observational study of Glaucoma and Ocular Hypertension, run by Robin, Alan L., M.D. at 1 site in United States.
Trial summary
This is a prospective, observational, single-center study. Patients with at least 3 months of experience using topical medications for glaucoma and who state that they administer their own eye drops will be recruited. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Ocular Hypertension
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to 1 Jun 2015
- 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: Private Ophthalmology Office (Specialty-Glaucoma)
Who may be able to join
- Patients aged 18 years or older
- Patients currently using topical ocular antihypertensive medications at the time of enrollment in at least one eye, and who have been using these drops consistently for a period of at least three months prior to enrollment.
- Patients with primary open angle glaucoma, pigmentary glaucoma, exfoliation glaucoma, ocular hypertension, normal-tension glaucoma, neovascular glaucoma, uveitic glaucoma and chronic narrow angle glaucoma.
- Patients CAN be enrolled even if they have co-existing morbidities such as Parkinson's Disease or arthritis
Who cannot join
- Patients who do not instill their own eye drops
- Patients who are not expected to still be using topical antihypertensive medications at the time of study follow-up
- Patients with no light perception vision
- Patients with a history of adverse reaction to artificial tears or any component of artificial tears
- Patients who have a typical follow-up period of greater than 6 months
- Patients who have not completed a Humphrey Visual Field C24-2 or C10-2 within 7 months of enrollment or study exit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Evaluation of the Effect of Training on Eye Drop Administration in Glaucoma Subjects Who Have Difficulties Properly Instilling Eye Drops
This is a prospective, observational, single-center study. Patients with at least 3 months of experience using topical medications for glaucoma and who state that they administer their own eye drops will be recruited. Subjects will be videotaped instilling a sterile artificial eye drop, will be identified at the time of a regularly scheduled exam. If the patient can get a drop onto the eye and also not touch their lids or ocular surface with the eye drop bottle, the subject will be thanked but not enrolled. All other patients who agree to participate will be enrolled. Upon completion of videotaped instillation of an eye drop, each enrolled patient will be shown a video demonstrating an instillation technique and will be given an instructional handout highlighting a proper drop instillation technique. If necessary, an instillation technique will be demonstrated to them by an investigator or trained personnel.
A patient will be identified as properly instilling a drop if they satisfy the following criteia:
Read more
They are able to instill one (and only one) drop to the ocular surface or lower fornix without allowing the bottle touch the adnexa, eyelid, eye lashes or eye.
All patients routinely return between 3 and 6 months. At this regularly scheduled visit,the investigator or trained personnel would direct the patient to instill an eye drop into the study eye.Additionally, the short glaucoma self-efficacy questionnaire will be re-administered.
All of the video-recordings of participants' eye drop instillation techniques will be reviewed and assessed using a standard checklist. Their ability to administer an eye drop after training will be compared to baseline.
- Conditions
- Glaucoma, Ocular Hypertension
- Keywords
- Glaucoma, Eye Drop, Eye Drop Technique, Training, Instilling Eye Drops
- Medical subject headings
- Glaucoma, Ocular Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to administer an eye drop according to our criteria, as outlined in our study summary.
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 posted1 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionJun 2015
- Study completion1 Jun 2015
Why it stopped: Enrollment Goals not met
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
- Other
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Robin, Alan L., M.D.
- Responsible party
- Principal investigator, Adam C. LePosa, Robin, Alan L., M.D.
- Investigators
- Adam C LePosa, OD, Principal investigator, Alan L. Robin, MD, PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01719809
- Sponsor's protocol ID
- ALR 0054
- Status last verified
- Apr 2017
- First submitted
- 25 Oct 2012
- Last updated
- 12 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Evaluation of the Effect of Training on Eye Drop Administration in Glaucoma Subjects Who Have Difficulties Properly Instilling Eye Drops
- ClinicalTrials.gov ID
- NCT01719809
- Acronym / sponsor ID
- ALR 0054
- Conditions
- Glaucoma, Ocular Hypertension
- Keywords
- Glaucoma, Eye Drop, Eye Drop Technique, Training, Instilling Eye Drops
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Enrollment Goals not met
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Robin, Alan L., M.D.
- Study start
- Oct 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- 1 Jun 2015 (actual)
- First posted
- 1 Nov 2012 (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 is a prospective, observational, single-center study. Patients with at least 3 months of experience using topical medications for glaucoma and who state that they administer their own eye drops will be recruited. Subjects will be videotaped instilling a sterile artificial eye drop, will be identified at the time of a regularly scheduled exam. If the patient can get a drop onto the eye and also not touch their lids or ocular surface with the eye drop bottle, the subject will be thanked but not enrolled. All other patients who agree to participate will be enrolled. Upon completion of videotaped instillation of an eye drop, each enrolled patient will be shown a video demonstrating an instillation technique and will be given an instructional handout highlighting a proper drop instillation technique. If necessary, an instillation technique will be demonstrated to them by an investigator or trained personnel.
A patient will be identified as properly instilling a drop if they satisfy the following criteia:
They are able to instill one (and only one) drop to the ocular surface or lower fornix without allowing the bottle touch the adnexa, eyelid, eye lashes or eye.
All patients routinely return between 3 and 6 months. At this regularly scheduled visit,the investigator or trained personnel would direct the patient to instill an eye drop into the study eye.Additionally, the short glaucoma self-efficacy questionnaire will be re-administered.
All of the video-recordings of participants' eye drop instillation techniques will be reviewed and assessed using a standard checklist. Their ability to administer an eye drop after training will be compared to baseline.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Private Ophthalmology Office (Specialty-Glaucoma)
Key inclusion criteria (4 listed)
- Patients aged 18 years or older
- Patients currently using topical ocular antihypertensive medications at the time of enrollment in at least one eye, and who have been using these drops consistently for a period of at least three months prior to enrollment.
- Patients with primary open angle glaucoma, pigmentary glaucoma, exfoliation glaucoma, ocular hypertension, normal-tension glaucoma, neovascular glaucoma, uveitic glaucoma and chronic narrow angle glaucoma.
- Patients CAN be enrolled even if they have co-existing morbidities such as Parkinson's Disease or arthritis
Key exclusion criteria (6 listed)
- Patients who do not instill their own eye drops
- Patients who are not expected to still be using topical antihypertensive medications at the time of study follow-up
- Patients with no light perception vision
- Patients with a history of adverse reaction to artificial tears or any component of artificial tears
- Patients who have a typical follow-up period of greater than 6 months
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
Ability to administer an eye drop according to our criteria, as outlined in our study summary.
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Enrollment Goals not met). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2017.
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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.
Adam C LePosa, OD principal investigator
Alan L. Robin, MD, PA
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 and Ocular Hypertension, 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 4 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: stopped early, as of the sponsor's last update on 12 Apr 2017. 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 was stopped early (reason given: Enrollment Goals not met). Results are not available in the source record.
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?
Ability to administer an eye drop according to our criteria, as outlined in our study summary. (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 12 Apr 2017.