GlaucomaNCT02867995
Efficacy of Glaucoma Drop Aids in Medication Compliance in the Patient Population at Boston Medical Center
A study testing Eye Drop Aid in people with Glaucoma, run by Boston Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine whether glaucoma drop aids will be cost-effective in delivery of ophthalmic medications by improving medication compliance, visual function, and even decreasing medication waste in the patient population at Boston Medical Center (BMC). Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Glaucoma
- What is being tested?
- Eye Drop Aid
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Mar 2017to 30 Mar 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18 years or greater
- Currently on the same topical medication for treatment of glaucoma for a minimum of two months
- Patient of Boston University eye Associates
- Agrees to use the drop aid with each delivery, return to the clinic after 6 weeks of using the drop aid, document completion of medication drops and fill out survey at the end of the 6 weeks
Who cannot join
- Less than age 18 years
- Changes glaucoma medication within the past two month or recent glaucoma surgery
- Older than 89 years of age
- Not a patient of the Boston University eye associate
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether glaucoma drop aids will be cost-effective in delivery of ophthalmic medications by improving medication compliance, visual function, and even decreasing medication waste in the patient population at Boston Medical Center (BMC).
Read the detailed description
Patients being treated for their glaucoma at BMC's Yawkey Eye Clinic will be selected according to the inclusion and exclusion criteria. The three drop aids used in this study will be the Fabrication Autodrop Eye Drop Guide, Owen Mumford OP 6100 Autosqueeze, and the Simply Touch Eye Drop Applicator. Patients will be randomly placed on one of these drops aids for a total of 3 study groups or the no drop aid control, for a total of 4 groups. Prior to use of the drop aid, patients will be instructed on how to use the drop aid by a resident physician and a pre- intervention intraocular pressure check will be performed by the resident physician using an applicator. Intraocular pressure is the only adjustable risk factor for glaucoma; thus, glaucoma treatments slow progression of glaucoma by reducing intraocular pressure. In addition, patients will be requested to deliver their drops with the drop aid with every use. Furthermore, each patient will record the number of days taken to complete the glaucoma medication bottle while using the drop aid. At the 3 and 6 week marks, the patient will fill out a satisfaction survey. Patients will need to return to the clinic at the 6 week mark and can fill out the satisfaction survey at the clinic in addition to checking the intraocular pressure post-intervention. Thus, the number of subject contact will be two, pre and post-intervention, the duration of participation for each subject will be 6 weeks, and the patient will also be required to fill out two satisfaction surveys. The effectiveness of the drop aids will be compared to the two controls and measured with any changes in intraocular pressure readings, length of time to medication completion, and patient satisfaction according to the surveys.
- Conditions
- Glaucoma
- Being tested
- Eye Drop Aid
- Keywords
- glaucoma drop aid
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye Drop AidDevice
Fabrication Autodrop Eye Drop Guide,Owen Mumford OP 6100 Autosqueeze, and the Simply Touch Eye Drop Applicator
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No glaucoma drop aid control |
| Eye Drop Aids | Active comparator | Participants could be placed into one of the drop aid groups (Fabrication Autodrop Eye Drop Guide,Owen Mumford OP 6100 Autosqueeze, or the Simply Touch Eye Drop Applicator) Receives: Device: Eye Drop Aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Assessed for Intraocular Pressure Change
Intraocular pressure (IOP) is measured by Goldman applanation in patients and is expressed in mmHg. The IOP, which is a routine check in the ophthalmic exam, was measured in the eye drop aid group prior to starting drop aid use and at six weeks while using drop aids. IOP was measured at baseline and at 6 weeks in the control group. A significant increase in IOP is defined as an increase of 4 mmHg or more, a significant decreases in IOP is defined as a decrease of 4mmHg or more. No significant change in the IOP is a change between 1-3 mmHg.
Measured: baseline and 6 weeks
Secondary outcomes (3)
Number of Participants Stratified by the Number of Times Eye Was Missed When Inserting Eye Drops
A question on the six week survey asked approximately how often the participant missed their eye when inserting eye drops. Response options included: missed inserting eye drops 0 times, missed inserting eye drops 1 time, missed inserting eye drops 2 times, or missed inserting eye drops 3 or more times.
Measured: 6 weeks
Satisfaction With Eye Drop Aid
A question on the six week survey asked if the participant liked the eye drop aid. Response options included: liked the drop aid long term, did not like the drop aid, or did not use a drop aid. Results were stratified by the three drop aid types (Fabrication Autodrop Eye Drop Guide, Owen Mumford OP 6100 Autosqueeze, or the Simply Touch Eye Drop Applicator).
Measured: 6 weeks
Intent to Use Eye Drop Aid Long Term
A question on the six week survey asked if the participant intended to use the eye drop aid long term. Response options included: would use the drop aid long term, would not use the drop aid long term, or did not use a drop aid. Results were stratified by the three drop aid types (Fabrication Autodrop Eye Drop Guide, Owen Mumford OP 6100 Autosqueeze, or the Simply Touch Eye Drop Applicator).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study start23 Mar 2017
- Primary completion30 Mar 2018
- Study completion30 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by Boston 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manishi Desai, Boston Medical Center
- Investigators
- Manishi Desai, MD, Principal investigator, Boston Medical CenterHaben Kefella, MD, Principal investigator, Boston Medical CenterAvni Badami, MD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02867995
- Sponsor's protocol ID
- H-34905
- Status last verified
- Jan 2019
- First submitted
- 7 Aug 2016
- Last updated
- 15 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Salyani A, Birt C. Evaluation of an eye drop guide to aid self-administration by patients experienced with topical use of glaucoma medication. Can J Ophthalmol. 2005 Apr;40(2):170-4. doi: 10.1016/S0008-4182(05)80028-6.
PubMed 16049530Ghate D, Edelhauser HF. Barriers to glaucoma drug delivery. J Glaucoma. 2008 Mar;17(2):147-56. doi: 10.1097/IJG.0b013e31814b990d.
PubMed 18344762Rivers PH. Compliance aids--do they work? Drugs Aging. 1992 Mar-Apr;2(2):103-11. doi: 10.2165/00002512-199202020-00004.
PubMed 1596593
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Glaucoma Drop Aids in Medication Compliance in the Patient Population at Boston Medical Center
- ClinicalTrials.gov ID
- NCT02867995
- Acronym / sponsor ID
- H-34905
- Conditions
- Glaucoma
- Keywords
- glaucoma drop aid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- 23 Mar 2017 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 30 Mar 2018 (actual)
- First posted
- 16 Aug 2016 (estimated)
- Results
- Posted 15 Feb 2019
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 determine whether glaucoma drop aids will be cost-effective in delivery of ophthalmic medications by improving medication compliance, visual function, and even decreasing medication waste in the patient population at Boston Medical Center (BMC).
Detailed description
Patients being treated for their glaucoma at BMC's Yawkey Eye Clinic will be selected according to the inclusion and exclusion criteria. The three drop aids used in this study will be the Fabrication Autodrop Eye Drop Guide, Owen Mumford OP 6100 Autosqueeze, and the Simply Touch Eye Drop Applicator. Patients will be randomly placed on one of these drops aids for a total of 3 study groups or the no drop aid control, for a total of 4 groups. Prior to use of the drop aid, patients will be instructed on how to use the drop aid by a resident physician and a pre- intervention intraocular pressure check will be performed by the resident physician using an applicator. Intraocular pressure is the only adjustable risk factor for glaucoma; thus, glaucoma treatments slow progression of glaucoma by reducing intraocular pressure. In addition, patients will be requested to deliver their drops with the drop aid with every use. Furthermore, each patient will record the number of days taken to complete the glaucoma medication bottle while using the drop aid. At the 3 and 6 week marks, the patient will fill out a satisfaction survey. Patients will need to return to the clinic at the 6 week mark and can fill out the satisfaction survey at the clinic in addition to checking the intraocular pressure post-intervention. Thus, the number of subject contact will be two, pre and post-intervention, the duration of participation for each subject will be 6 weeks, and the patient will also be required to fill out two satisfaction surveys. The effectiveness of the drop aids will be compared to the two controls and measured with any changes in intraocular pressure readings, length of time to medication completion, and patient satisfaction according to the surveys.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No glaucoma drop aid control |
| Eye Drop Aids | Active comparator | Device: Eye Drop AidParticipants could be placed into one of the drop aid groups (Fabrication Autodrop Eye Drop Guide,Owen Mumford OP 6100 Autosqueeze, or the Simply Touch Eye Drop Applicator) |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 18 years or greater
- Currently on the same topical medication for treatment of glaucoma for a minimum of two months
- Patient of Boston University eye Associates
- Agrees to use the drop aid with each delivery, return to the clinic after 6 weeks of using the drop aid, document completion of medication drops and fill out survey at the end of the 6 weeks
Key exclusion criteria (4 listed)
- Less than age 18 years
- Changes glaucoma medication within the past two month or recent glaucoma surgery
- Older than 89 years of age
- Not a patient of the Boston University eye associate
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 |
|---|---|---|
| Eye Drop AidFabrication Autodrop Eye Drop Guide,Owen Mumford OP 6100 Autosqueeze, and the Simply Touch Eye Drop Applicator | Device | Eye Drop Aids |
Primary outcome
Number of Participants Assessed for Intraocular Pressure Change
Time frame: baseline and 6 weeks
Intraocular pressure (IOP) is measured by Goldman applanation in patients and is expressed in mmHg. The IOP, which is a routine check in the ophthalmic exam, was measured in the eye drop aid group prior to starting drop aid use and at six weeks while using drop aids. IOP was measured at baseline and at 6 weeks in the control group. A significant increase in IOP is defined as an increase of 4 mmHg or more, a significant decreases in IOP is defined as a decrease of 4mmHg or more. No significant change in the IOP is a change between 1-3 mmHg.
3 secondary outcomes
Number of Participants Stratified by the Number of Times Eye Was Missed When Inserting Eye Drops
Time frame: 6 weeks
Satisfaction With Eye Drop Aid
Time frame: 6 weeks
Intent to Use Eye Drop Aid Long Term
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16049530Salyani A, Birt C. Evaluation of an eye drop guide to aid self-administration by patients experienced with topical use of glaucoma medication. Can J Ophthalmol. 2005 Apr;40(2):170-4. doi: 10.1016/S0008-4182(05)80028-6.
- Background: PubMed 18344762Ghate D, Edelhauser HF. Barriers to glaucoma drug delivery. J Glaucoma. 2008 Mar;17(2):147-56. doi: 10.1097/IJG.0b013e31814b990d.
- Background: PubMed 1596593Rivers PH. Compliance aids--do they work? Drugs Aging. 1992 Mar-Apr;2(2):103-11. doi: 10.2165/00002512-199202020-00004.
- Individual participant dataSharing planned: Undecided
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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.
Manishi Desai, MD principal investigator
Boston Medical Center
Haben Kefella, MD principal investigator
Boston Medical Center
Avni Badami, MD principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eye Drop Aid in people with Glaucoma, run by Boston Medical Center 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 4 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 15 Feb 2019. 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?
Yes. Results are posted in the registry (first posted 15 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Assessed for Intraocular Pressure Change (time frame: baseline and 6 weeks). 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 NCT02867995, which also lists 3 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 15 Feb 2019.