Glaucoma Drop Aids Part 2

NCT06806332 | Not Yet Recruiting FDA Device

• 1 other identifier: H-45629
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma; Intraocular Pressure

Keywords

Eye drop aid; Nanodropper

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  12 weeks

Secondary Outcomes (1)

• Change in intraocular pressure with drop aid

  before starting the drop aid, after 6 weeks of using the drop aid

Study Arms (2)

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.

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.

Device: Nanodropper

Interventions

Nanodropper DEVICE

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.

Also known as: Drop aid

Drop aid used then no drop aid; No drop aid then drop aid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Changed glaucoma medications within the past 2 months

Sponsors & Collaborators

• Boston Medical Center: lead
• Boston Medical Center Patient Safety Grant: collaborator

Study Sites (1)

Yawkey Eye Clinic, Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Manishi Desai, MD

  BostonMedical Center, Ophthalmology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manishi Desai, MD

CONTACT

617 414 2020; manishi.desai@bmc.org

Sreevardhan Alluri, MPH

CONTACT

617 414 8848; sreevardhan.alluri@bmc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 4, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)