Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2026-01-02 @ 10:18 AM
Study NCT ID:
NCT06806332
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-01
First Post:
2025-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Glaucoma Drop Aids Part 2
Sponsor:
Boston Medical Center
Organization:
Study Overview
Official Title:
Glaucoma Drop Aids Part 2
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: