GlaucomaNCT00522600
Eye Drop Use in Glaucoma Patients Through Patient Surveys and Video Observations
An observational study of Glaucoma and Dry Eye Syndrome, run by Robin, Alan L., M.D. at 1 site in United States.
Trial summary
This study will be used to evaluate how patients put eye drops in their eyes and any problems that may arise from this activity. The information gathered will help identify common problems patients are having with putting in their eye medications. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Dry Eye Syndrome, Conjunctivitis
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Jul 2007
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 173 subjects enrolled and 222 video recordings were made. Ages ranged from 21-94 years old (mean:67 yrs) and subjects were 55% female and 70% caucasian.
Who may be able to join
- Currently using topical glaucoma medications
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Eye Drop Administration in Glaucoma Patients
This study will be used to evaluate how patients put eye drops in their eyes and any problems that may arise from this activity. The information gathered will help identify common problems patients are having with putting in their eye medications. Then doctors can be better informed about the issues and provide better advice to their patients to overcome these problems.
Read the detailed description
Approximately 100 patients will take part in a one time procedure and survey as part of this project. After appropriate consent patients are asked to complete a short 2 page survey about themselves and their eye drops. Then a video recording will be made of the patient instilling eye drops in their habitual manner. The eye drops used will be sterile saline placed in either Travatan-like or Systane bottles to simulate the corresponding prescribed medication. The videos will be graded for instillation technique and combined with scoring of survey answers.
Patients will be asked to instill the drops to their left eye with their dominant hand as we expect this to be most difficult. Patients with severe (>20/200) vision loss will instill drops into their better seeing eye.
- Conditions
- Glaucoma, Dry Eye Syndrome, Conjunctivitis
- Keywords
- eyedrops, compliance, glaucoma medications, adherence
- Medical subject headings
- Glaucoma, Dry Eye Syndromes, Conjunctivitis, Patient Compliance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2007 (estimated)
- Study startFeb 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Robin, Alan L., M.D.
- Collaborators
- Alcon Research
- Investigators
- Jennifer L Stone, OD, Principal investigator, Alan L Robin MD PAAlan L Robin, MD, Study director, Alan L Robin MD PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00522600
- Sponsor's protocol ID
- SI0717
- Status last verified
- Jul 2009
- First submitted
- 29 Aug 2007
- Last updated
- 22 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Stone JL, Robin AL, Novack GD, Covert DW, Cagle GD. An objective evaluation of eyedrop instillation in patients with glaucoma. Arch Ophthalmol. 2009 Jun;127(6):732-6. doi: 10.1001/archophthalmol.2009.96.
PubMed 19506189
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Eye Drop Administration in Glaucoma Patients
- ClinicalTrials.gov ID
- NCT00522600
- Acronym / sponsor ID
- SI0717
- Conditions
- Glaucoma, Dry Eye Syndrome, Conjunctivitis
- Keywords
- eyedrops, compliance, glaucoma medications, adherence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Robin, Alan L., M.D.
- Collaborators
- Alcon Research
- Study start
- Feb 2007
- Study completion
- Jul 2007 (actual)
- First posted
- 30 Aug 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.
This study will be used to evaluate how patients put eye drops in their eyes and any problems that may arise from this activity. The information gathered will help identify common problems patients are having with putting in their eye medications. Then doctors can be better informed about the issues and provide better advice to their patients to overcome these problems.
Detailed description
Approximately 100 patients will take part in a one time procedure and survey as part of this project. After appropriate consent patients are asked to complete a short 2 page survey about themselves and their eye drops. Then a video recording will be made of the patient instilling eye drops in their habitual manner. The eye drops used will be sterile saline placed in either Travatan-like or Systane bottles to simulate the corresponding prescribed medication. The videos will be graded for instillation technique and combined with scoring of survey answers.
Patients will be asked to instill the drops to their left eye with their dominant hand as we expect this to be most difficult. Patients with severe (>20/200) vision loss will instill drops into their better seeing eye.
Study design
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 173 subjects enrolled and 222 video recordings were made. Ages ranged from 21-94 years old (mean:67 yrs) and subjects were 55% female and 70% caucasian.
Key inclusion criteria (1 listed)
- Currently using topical glaucoma medications
Key exclusion criteria (0 listed)
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 22 Jul 2009.
- Derived from this study: PubMed 19506189Stone JL, Robin AL, Novack GD, Covert DW, Cagle GD. An objective evaluation of eyedrop instillation in patients with glaucoma. Arch Ophthalmol. 2009 Jun;127(6):732-6. doi: 10.1001/archophthalmol.2009.96.
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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
Alan L Robin MD PA
Alan L Robin, MD study director
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 Dry Eye Syndrome, 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 1 inclusion and 0 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 22 Jul 2009. 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?
On the ClinicalTrials.gov record for NCT00522600, which also lists 1 linked publication.
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 22 Jul 2009.