GlaucomaNCT06806332
Glaucoma Drop Aids Part 2
A study testing Nanodropper in people with Glaucoma and Intraocular Pressure, run by Boston Medical Center at 1 site in United States.
Trial summary
Glaucoma medications are vital to disease management and prevention of further loss of vision as over time glaucoma will lead to irreversible blindness. The average size of a glaucoma medication bottle is around 10cc and these medications when used 2-3 times daily are expected to last patients an entire month. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Intraocular Pressure
- What is being tested?
- Nanodropper
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Currently on the same topical ophthalmic medications for treatment of glaucoma for a minimum of two months
- Patient of Boston University Eye Associates
Who cannot join
- Changed glaucoma medications within the past 2 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Yawkey Eye Clinic, Boston Medical Center
Boston, Massachusetts, 02118
Manishi Desai, MD, 617-414-2020, manishi.desai@bmc.org
Sreevardhan Alluri, MPH, 617 414 8848, sreevardhan.alluri@bmc.org
About this study
Glaucoma medications are vital to disease management and prevention of further loss of vision as over time glaucoma will lead to irreversible blindness. The average size of a glaucoma medication bottle is around 10cc and these medications when used 2-3 times daily are expected to last patients an entire month. The investigators found that at Boston Medical Center (BMC) a majority of Yawkey Eye Clinic patients are unable to deliver the drops into their eyes due to poor vision or difficulty squeezing drop bottles. These patients also often deliver more than a necessary amount leading to premature completion of the bottle. However, because the cost benefit ratio of these drop aids is unclear, they are not routinely offered to the patients. Although the efficacy of these drop aids has not been well studied, if effective, the cost of these drop aids would more than pay themselves by improving medication compliance and visual function of the patients. This study aims to determine the efficacy of the Nanodropper in the BMC Yawkey Eye Clinic patient population.
Read the detailed description
A randomized, crossover study design will be used to determine the efficacy of the Nanodropper in the BMC Yawkey Eye Clinic patient population. All participants will receive the Nanodropper, but will be randomly assigned to study groups defined by the order in which they use the Nanodropper. The first group will be assigned to use the drop aid device over the first 4-6 weeks, and then no drop aid device over the next 4-6 weeks. The second group will be assigned to use no drop aid device over the first 4-6 weeks, and then the drop aid device over the next 4-6 weeks. Therefore, each participant will undergo two study periods (using the drop aid and not using the drop aid).
Prior to use of the Nanodropper, participants will be instructed on how to use the drop aid by a member of the research team and a preintervention intraocular pressure check will be performed using an applanator which is part of the patient's standard of care. Intraocular pressure is the only adjustable risk factor for glaucoma; thus, glaucoma treatments slow progression of glaucoma by reducing intraocular pressure.
After 3 weeks and after at least 6 weeks per study period, participants will complete a satisfaction survey for the drop aid treatment group or control group. The 3 week satisfaction survey will take place over the phone. As part of routine eye care, participants will need to return to the clinic at least 6 week after enrollment. During this visit, a satisfaction survey will be completed, the participant's study diary will be collected, and routine intraocular pressure checks will be documented. If the participant does not complete the home study diary or forgets to bring it in to their appointment, a member of the study team will help them fill it out at a follow-up clinic appointment. The duration of participation for each subject will be 8-12 weeks.
The efficacy of the Nanodropper will be compared to the control and measured with any changes in intraocular pressure readings, length of time to medication completion, and patient satisfaction according to the surveys.
- Conditions
- Glaucoma, Intraocular Pressure
- Being tested
- Nanodropper
- Keywords
- Eye drop aid, Nanodropper
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NanodropperDevice
Also called Drop aid
The Nanodropper is the only FDA-listed, volume-reducing adaptor for eyedrop bottles. By twisting the Nanodropper onto a compatible bottle, the drop-size can be reduced by over 60%. Smaller drops have been shown to reduce waste, cost, and side effects.
| Study group | Role | What they receive |
|---|---|---|
| Drop aid used then no drop aid | Experimental | Participants randomized into this group will be assigned to use the Nanodropper over the first 4-6 weeks, and then no drop aid device over the next 4-6 weeks. Receives: Device: Nanodropper |
| No drop aid then drop aid | Experimental | Participants randomized into this group will be assigned to use no drop aid over the first 4-6 weeks, and then to use the Nanodropper over the next 4-6 weeks. Receives: Device: Nanodropper |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of topical ophthalmic drug bottle
This outcome will be measured in days by the patient from when a bottle is started until all the medication has been used.
Measured: 12 weeks
Satisfaction with dispensing opthalmic medication
An investigator developed survey completed by participants will be used to assess participants' satisfaction of eye drops with and without the drop aid.
Measured: 12 weeks
Secondary outcomes (1)
Change in intraocular pressure with drop aid
An applanator will be used to measure the intraocular pressure during standard of care appointments.
Measured: before starting the drop aid, after 6 weeks of using the drop aid
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study startOct 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Medical Center Patient Safety Grant
- Responsible party
- Sponsor
- Investigators
- Manishi Desai, MD, Principal investigator, BostonMedical Center, Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06806332
- Sponsor's protocol ID
- H-45629
- Status last verified
- Jul 2026
- First submitted
- 29 Jan 2025
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glaucoma Drop Aids Part 2
- ClinicalTrials.gov ID
- NCT06806332
- Acronym / sponsor ID
- H-45629
- Conditions
- Glaucoma, Intraocular Pressure
- Keywords
- Eye drop aid, Nanodropper
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- Boston Medical Center Patient Safety Grant
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 4 Feb 2025 (actual)
- 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.
Glaucoma medications are vital to disease management and prevention of further loss of vision as over time glaucoma will lead to irreversible blindness. The average size of a glaucoma medication bottle is around 10cc and these medications when used 2-3 times daily are expected to last patients an entire month. The investigators found that at Boston Medical Center (BMC) a majority of Yawkey Eye Clinic patients are unable to deliver the drops into their eyes due to poor vision or difficulty squeezing drop bottles. These patients also often deliver more than a necessary amount leading to premature completion of the bottle. However, because the cost benefit ratio of these drop aids is unclear, they are not routinely offered to the patients. Although the efficacy of these drop aids has not been well studied, if effective, the cost of these drop aids would more than pay themselves by improving medication compliance and visual function of the patients. This study aims to determine the efficacy of the Nanodropper in the BMC Yawkey Eye Clinic patient population.
Detailed description
A randomized, crossover study design will be used to determine the efficacy of the Nanodropper in the BMC Yawkey Eye Clinic patient population. All participants will receive the Nanodropper, but will be randomly assigned to study groups defined by the order in which they use the Nanodropper. The first group will be assigned to use the drop aid device over the first 4-6 weeks, and then no drop aid device over the next 4-6 weeks. The second group will be assigned to use no drop aid device over the first 4-6 weeks, and then the drop aid device over the next 4-6 weeks. Therefore, each participant will undergo two study periods (using the drop aid and not using the drop aid).
Prior to use of the Nanodropper, participants will be instructed on how to use the drop aid by a member of the research team and a preintervention intraocular pressure check will be performed using an applanator which is part of the patient's standard of care. Intraocular pressure is the only adjustable risk factor for glaucoma; thus, glaucoma treatments slow progression of glaucoma by reducing intraocular pressure.
After 3 weeks and after at least 6 weeks per study period, participants will complete a satisfaction survey for the drop aid treatment group or control group. The 3 week satisfaction survey will take place over the phone. As part of routine eye care, participants will need to return to the clinic at least 6 week after enrollment. During this visit, a satisfaction survey will be completed, the participant's study diary will be collected, and routine intraocular pressure checks will be documented. If the participant does not complete the home study diary or forgets to bring it in to their appointment, a member of the study team will help them fill it out at a follow-up clinic appointment. The duration of participation for each subject will be 8-12 weeks.
The efficacy of the Nanodropper will be compared to the control 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
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drop aid used then no drop aid | Experimental | Device: NanodropperParticipants randomized into this group will be assigned to use the Nanodropper over the first 4-6 weeks, and then no drop aid device over the next 4-6 weeks. |
| No drop aid then drop aid | Experimental | Device: NanodropperParticipants randomized into this group will be assigned to use no drop aid over the first 4-6 weeks, and then to use the Nanodropper over the next 4-6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Currently on the same topical ophthalmic medications for treatment of glaucoma for a minimum of two months
- Patient of Boston University Eye Associates
Key exclusion criteria (1 listed)
- Changed glaucoma medications within the past 2 months
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 |
|---|---|---|
| NanodropperAlso: Drop aidThe Nanodropper is the only FDA-listed, volume-reducing adaptor for eyedrop bottles. By twisting the Nanodropper onto a compatible bottle, the drop-size can be reduced by over 60%. Smaller drops have been shown to reduce waste, cost, and side effects. | Device | Drop aid used then no drop aid, No drop aid then drop aid |
Primary outcome
Completion of topical ophthalmic drug bottle
Time frame: 12 weeks
This outcome will be measured in days by the patient from when a bottle is started until all the medication has been used.
Satisfaction with dispensing opthalmic medication
Time frame: 12 weeks
An investigator developed survey completed by participants will be used to assess participants' satisfaction of eye drops with and without the drop aid.
1 secondary outcome
Change in intraocular pressure with drop aid
Time frame: before starting the drop aid, after 6 weeks of using the drop aid
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Manishi Desai, MD principal investigator
BostonMedical Center, 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 Nanodropper in people with Glaucoma and Intraocular Pressure, 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 2 inclusion and 1 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: opening soon, as of the sponsor's last update on 28 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manishi Desai, MD (617 414 2020, manishi.desai@bmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of topical ophthalmic drug bottle (time frame: 12 weeks). 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 28 Jul 2026.