Clinical trial NCT06806332: Glaucoma Drop Aids Part 2
Official title: Glaucoma Drop Aids Part 2
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Glaucoma
Intraocular Pressure
Keywords: Eye drop aid
Nanodropper
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: Boston Medical Center Patient Safety Grant
First posted: 2025-02-04
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Currently on the same topical ophthalmic medications for treatment of glaucoma for a minimum of two months
* Patient of Boston University Eye Associates

Exclusion Criteria:

* Changed glaucoma medications within the past 2 months

Primary outcomes:
measure: Completion of topical ophthalmic drug bottle
timeFrame: 12 weeks
measure: Satisfaction with dispensing opthalmic medication
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in intraocular pressure with drop aid
timeFrame: before starting the drop aid, after 6 weeks of using the drop aid
Other outcomes:
Locations:
city: Boston
country: United States
facility: Yawkey Eye Clinic, Boston Medical Center
state: Massachusetts
Study officials:
affiliation: BostonMedical Center, Ophthalmology
name: Manishi Desai, MD
role: PRINCIPAL_INVESTIGATOR
References: