Glaucoma, Open-AngleNCT01416415
Glaucoma Eye Drop Instillation: Impact of Education
A study testing Video education on proper eye drop instillation technique in people with Glaucoma, Open-Angle, run by Northwestern University at 1 site in United States.
Trial summary
The purpose of this study is to assess whether an educational intervention will have a positive effect on patients' ability to properly administer eye drops. The investigators predict that the educational intervention will have a positive impact on the efficacy, safety, and efficiency with which patients administer… Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Glaucoma, Open-Angle
- What is being tested?
- Video education on proper eye drop instillation technique
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Jun 2013
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Established care with the treating ophthalmologist for at least 6 months
- Diagnosis of open-angle glaucoma or ocular hypertension
- The use of one, two or three self-instilled eye drop medications in one or two eyes
- Age 40-85 years
- Fluency in English
- Best corrected visual acuity (BCVA) of 20/50 or better in each eye
Who cannot join
- Presence of moderate to severe cognitive deficits
- Presence of a clinically significant tremor
- Mini Mental Status Exam score ≤ 20
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Medical Faculty Foundation
Chicago, Illinois, 60611
About this study
The purpose of this study is to assess whether an educational intervention will have a positive effect on patients' ability to properly administer eye drops. The investigators predict that the educational intervention will have a positive impact on the efficacy, safety, and efficiency with which patients administer their eye drops.
Read the detailed description
Glaucoma is a leading cause of irreversible vision loss worldwide, and as such has a large public health impact. The only treatment proven to slow or arrest the progression of the disease process is intraocular pressure (IOP) reduction, which relies heavily on patient cooperation. Previously, nonadherence to glaucoma medications has ranged from 24% to 59%. Barriers to medication compliance in the glaucoma patient population include health literacy, poor comprehension of disease, poor comprehension of medication regimen, and improper eye drop administration technique. The purpose of this randomized, controlled clinical trial is to assess whether an educational intervention will have a positive effect on patients' ability to properly administer eye drops. Patients randomized to the experimental group will receive the educational intervention, consisting of an instructional video demonstrating how to instill eyedrops. Patients randomized to the control group will receive an attention placebo, consisting of a video regarding healthy eating tips. Additional measures that will be obtained from all patients include a health literacy score, as measured using the REALM questionnaire, and a BMQ - specific score (Beliefs about Medicines Questionnaire) using the BMQ-specific questionnaire. If the education protocol is found to positively affect eye drop administration success, as demonstrated by a statistically significant difference between the experimental and control groups, suggestions will be proposed for the implementation of educational programs similar to ours to improve glaucoma patient outcomes.
- Conditions
- Glaucoma, Open-Angle
- Being tested
- Video education on proper eye drop instillation technique, Placebo video education on healthy eating tips
- Keywords
- Glaucoma, Open-Angle, Ophthalmic Solutions, Eye drops, Instructional Films and Videos
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video education on proper eye drop instillation techniqueOther
The video is approximately seven minutes long and teaches the Robert Ritch method of instilling eye drops.
Placebo video education on healthy eating tipsOther
The video is approximately seven minutes long and teaches tips to promote healthy eating.
| Study group | Role | What they receive |
|---|---|---|
| Educational intervention | Experimental | The educational intervention arm will contain subjects who will watch a video on proper eye drop instillation technique. Receives: Other: Video education on proper eye drop instillation technique |
| Attention placebo | Placebo comparator | The attention control placebo group will receive an educational intervention that mimics the amount of time and attention received by the treatment group. The video chosen is regarding healthy eating tips. Receives: Other: Placebo video education on healthy eating tips |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eye drop instillation score
The eye drop instillation score is a composite score of the efficacy, safety, and efficiency with which the subject instills their eyedrops and is simply a measure of how well the subject administers their eyedrops.
Measured: 4 +/- 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionJun 2013
- Study completionJun 2013
Why it stopped: Not practical to continue due interim results
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Glaucoma, Open-AngleStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angelo Tanna, Northwestern University
- Investigators
- Angelo P Tanna, M.D., Principal investigator, Northwestern University Department of Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01416415
- Sponsor's protocol ID
- NU 00051931
- Status last verified
- Apr 2018
- First submitted
- 11 Aug 2011
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Kulkarni SV, Damji KF, Buys YM. Medical management of primary open-angle glaucoma: Best practices associated with enhanced patient compliance and persistency. Patient Prefer Adherence. 2008 Feb 2;2:303-14. doi: 10.2147/ppa.s4163.
PubMed 19920977Nemesure B, Honkanen R, Hennis A, Wu SY, Leske MC; Barbados Eye Studies Group. Incident open-angle glaucoma and intraocular pressure. Ophthalmology. 2007 Oct;114(10):1810-5. doi: 10.1016/j.ophtha.2007.04.003. Epub 2007 Jun 20.
PubMed 17583352The Advanced Glaucoma Intervention Study (AGIS): 7. The relationship between control of intraocular pressure and visual field deterioration.The AGIS Investigators. Am J Ophthalmol. 2000 Oct;130(4):429-40. doi: 10.1016/s0002-9394(00)00538-9.
PubMed 11024415Kass MA, Heuer DK, Higginbotham EJ, Johnson CA, Keltner JL, Miller JP, Parrish RK 2nd, Wilson MR, Gordon MO. The Ocular Hypertension Treatment Study: a randomized trial determines that topical ocular hypotensive medication delays or prevents the onset of primary open-angle glaucoma. Arch Ophthalmol. 2002 Jun;120(6):701-13; discussion 829-30. doi: 10.1001/archopht.120.6.701.
PubMed 12049574The effectiveness of intraocular pressure reduction in the treatment of normal-tension glaucoma. Collaborative Normal-Tension Glaucoma Study Group. Am J Ophthalmol. 1998 Oct;126(4):498-505. doi: 10.1016/s0002-9394(98)00272-4.
PubMed 9780094Lichter PR, Musch DC, Gillespie BW, Guire KE, Janz NK, Wren PA, Mills RP; CIGTS Study Group. Interim clinical outcomes in the Collaborative Initial Glaucoma Treatment Study comparing initial treatment randomized to medications or surgery. Ophthalmology. 2001 Nov;108(11):1943-53. doi: 10.1016/s0161-6420(01)00873-9.
PubMed 11713061Gold DT, McClung B. Approaches to patient education: emphasizing the long-term value of compliance and persistence. Am J Med. 2006 Apr;119(4 Suppl 1):S32-7. doi: 10.1016/j.amjmed.2005.12.021.
PubMed 16563940Vakil N. Increasing compliance with long-term therapy: avoiding complications and adverse events. Rev Gastroenterol Disord. 2005;5 Suppl 2:S12-7.
PubMed 16369223Gurwitz JH, Glynn RJ, Monane M, Everitt DE, Gilden D, Smith N, Avorn J. Treatment for glaucoma: adherence by the elderly. Am J Public Health. 1993 May;83(5):711-6. doi: 10.2105/ajph.83.5.711.
PubMed 8484454Schwartz GF. Compliance and persistency in glaucoma follow-up treatment. Curr Opin Ophthalmol. 2005 Apr;16(2):114-21. doi: 10.1097/01.icu.0000156139.05323.26.
PubMed 15744142Tsai JC, McClure CA, Ramos SE, Schlundt DG, Pichert JW. Compliance barriers in glaucoma: a systematic classification. J Glaucoma. 2003 Oct;12(5):393-8. doi: 10.1097/00061198-200310000-00001.
PubMed 14520147Rotchford AP, Murphy KM. Compliance with timolol treatment in glaucoma. Eye (Lond). 1998;12 ( Pt 2):234-6. doi: 10.1038/eye.1998.56.
PubMed 9683946Patel SC, Spaeth GL. Compliance in patients prescribed eyedrops for glaucoma. Ophthalmic Surg. 1995 May-Jun;26(3):233-6.
PubMed 7651690Dietlein TS, Jordan JF, Luke C, Schild A, Dinslage S, Krieglstein GK. Self-application of single-use eyedrop containers in an elderly population: comparisons with standard eyedrop bottle and with younger patients. Acta Ophthalmol. 2008 Dec;86(8):856-9. doi: 10.1111/j.1755-3768.2007.01155.x. Epub 2008 May 20.
PubMed 18494743Djafari F, Lesk MR, Harasymowycz PJ, Desjardins D, Lachaine J. Determinants of adherence to glaucoma medical therapy in a long-term patient population. J Glaucoma. 2009 Mar;18(3):238-43. doi: 10.1097/IJG.0b013e3181815421.
PubMed 19295380
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glaucoma Eye Drop Instillation: Impact of Education
- ClinicalTrials.gov ID
- NCT01416415
- Acronym / sponsor ID
- NU 00051931
- Conditions
- Glaucoma, Open-Angle
- Keywords
- Glaucoma, Open-Angle, Ophthalmic Solutions, Eye drops, Instructional Films and Videos
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not practical to continue due interim results
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 15 Aug 2011 (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 assess whether an educational intervention will have a positive effect on patients' ability to properly administer eye drops. The investigators predict that the educational intervention will have a positive impact on the efficacy, safety, and efficiency with which patients administer their eye drops.
Detailed description
Glaucoma is a leading cause of irreversible vision loss worldwide, and as such has a large public health impact. The only treatment proven to slow or arrest the progression of the disease process is intraocular pressure (IOP) reduction, which relies heavily on patient cooperation. Previously, nonadherence to glaucoma medications has ranged from 24% to 59%. Barriers to medication compliance in the glaucoma patient population include health literacy, poor comprehension of disease, poor comprehension of medication regimen, and improper eye drop administration technique. The purpose of this randomized, controlled clinical trial is to assess whether an educational intervention will have a positive effect on patients' ability to properly administer eye drops. Patients randomized to the experimental group will receive the educational intervention, consisting of an instructional video demonstrating how to instill eyedrops. Patients randomized to the control group will receive an attention placebo, consisting of a video regarding healthy eating tips. Additional measures that will be obtained from all patients include a health literacy score, as measured using the REALM questionnaire, and a BMQ - specific score (Beliefs about Medicines Questionnaire) using the BMQ-specific questionnaire. If the education protocol is found to positively affect eye drop administration success, as demonstrated by a statistically significant difference between the experimental and control groups, suggestions will be proposed for the implementation of educational programs similar to ours to improve glaucoma patient outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educational intervention | Experimental | Other: Video education on proper eye drop instillation techniqueThe educational intervention arm will contain subjects who will watch a video on proper eye drop instillation technique. |
| Attention placebo | Placebo comparator | Other: Placebo video education on healthy eating tipsThe attention control placebo group will receive an educational intervention that mimics the amount of time and attention received by the treatment group. The video chosen is regarding healthy eating tips. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Established care with the treating ophthalmologist for at least 6 months
- Diagnosis of open-angle glaucoma or ocular hypertension
- The use of one, two or three self-instilled eye drop medications in one or two eyes
- Age 40-85 years
- Fluency in English
Key exclusion criteria (3 listed)
- Presence of moderate to severe cognitive deficits
- Presence of a clinically significant tremor
- Mini Mental Status Exam score ≤ 20
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 |
|---|---|---|
| Video education on proper eye drop instillation techniqueThe video is approximately seven minutes long and teaches the Robert Ritch method of instilling eye drops. | Other | Educational intervention |
| Placebo video education on healthy eating tipsThe video is approximately seven minutes long and teaches tips to promote healthy eating. | Other | Attention placebo |
Primary outcome
Eye drop instillation score
Time frame: 4 +/- 3 months
The eye drop instillation score is a composite score of the efficacy, safety, and efficiency with which the subject instills their eyedrops and is simply a measure of how well the subject administers their eyedrops.
Results and safety
The study was stopped early (reason given: Not practical to continue due interim results). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
- Background: PubMed 19920977Kulkarni SV, Damji KF, Buys YM. Medical management of primary open-angle glaucoma: Best practices associated with enhanced patient compliance and persistency. Patient Prefer Adherence. 2008 Feb 2;2:303-14. doi: 10.2147/ppa.s4163.
- Background: PubMed 17583352Nemesure B, Honkanen R, Hennis A, Wu SY, Leske MC; Barbados Eye Studies Group. Incident open-angle glaucoma and intraocular pressure. Ophthalmology. 2007 Oct;114(10):1810-5. doi: 10.1016/j.ophtha.2007.04.003. Epub 2007 Jun 20.
- Background: PubMed 11024415The Advanced Glaucoma Intervention Study (AGIS): 7. The relationship between control of intraocular pressure and visual field deterioration.The AGIS Investigators. Am J Ophthalmol. 2000 Oct;130(4):429-40. doi: 10.1016/s0002-9394(00)00538-9.
- Background: PubMed 12049574Kass MA, Heuer DK, Higginbotham EJ, Johnson CA, Keltner JL, Miller JP, Parrish RK 2nd, Wilson MR, Gordon MO. The Ocular Hypertension Treatment Study: a randomized trial determines that topical ocular hypotensive medication delays or prevents the onset of primary open-angle glaucoma. Arch Ophthalmol. 2002 Jun;120(6):701-13; discussion 829-30. doi: 10.1001/archopht.120.6.701.
- Background: PubMed 9780094The effectiveness of intraocular pressure reduction in the treatment of normal-tension glaucoma. Collaborative Normal-Tension Glaucoma Study Group. Am J Ophthalmol. 1998 Oct;126(4):498-505. doi: 10.1016/s0002-9394(98)00272-4.
- Background: PubMed 11713061Lichter PR, Musch DC, Gillespie BW, Guire KE, Janz NK, Wren PA, Mills RP; CIGTS Study Group. Interim clinical outcomes in the Collaborative Initial Glaucoma Treatment Study comparing initial treatment randomized to medications or surgery. Ophthalmology. 2001 Nov;108(11):1943-53. doi: 10.1016/s0161-6420(01)00873-9.
- Background: PubMed 16563940Gold DT, McClung B. Approaches to patient education: emphasizing the long-term value of compliance and persistence. Am J Med. 2006 Apr;119(4 Suppl 1):S32-7. doi: 10.1016/j.amjmed.2005.12.021.
- Background: PubMed 16369223Vakil N. Increasing compliance with long-term therapy: avoiding complications and adverse events. Rev Gastroenterol Disord. 2005;5 Suppl 2:S12-7.
- Background: PubMed 8484454Gurwitz JH, Glynn RJ, Monane M, Everitt DE, Gilden D, Smith N, Avorn J. Treatment for glaucoma: adherence by the elderly. Am J Public Health. 1993 May;83(5):711-6. doi: 10.2105/ajph.83.5.711.
- Background: PubMed 15744142Schwartz GF. Compliance and persistency in glaucoma follow-up treatment. Curr Opin Ophthalmol. 2005 Apr;16(2):114-21. doi: 10.1097/01.icu.0000156139.05323.26.
- Background: PubMed 14520147Tsai JC, McClure CA, Ramos SE, Schlundt DG, Pichert JW. Compliance barriers in glaucoma: a systematic classification. J Glaucoma. 2003 Oct;12(5):393-8. doi: 10.1097/00061198-200310000-00001.
- Background: PubMed 9683946Rotchford AP, Murphy KM. Compliance with timolol treatment in glaucoma. Eye (Lond). 1998;12 ( Pt 2):234-6. doi: 10.1038/eye.1998.56.
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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.
Angelo P Tanna, M.D. principal investigator
Northwestern University Department of Ophthalmology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video education on proper eye drop instillation technique in people with Glaucoma, Open-Angle, run by Northwestern 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 6 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: stopped early, as of the sponsor's last update on 5 Apr 2018. 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. Some participants in this study may receive a placebo. 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: Not practical to continue due interim results). 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?
Eye drop instillation score (time frame: 4 +/- 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01416415, which also lists 17 linked publications.
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 5 Apr 2018.