Use of Nanodropper vs. Standard Eyedropper in Patients With Glaucoma and Ocular Hypertension

The purpose of this study is to evaluate the safety, efficacy, and usability of an eyedrop bottle adaptor that creates smaller eyedrops, Nanodropper, in an open-angle glaucoma/ocular hypertension patient population.

Study Overview

• Status: Recruiting
• Conditions: Ocular Hypertension; Glaucoma, Open-Angle
• Intervention / Treatment: Device: control; Device: Nanodropper adaptor

Detailed Description

This 6-month prospective, randomized, single-masked, active-controlled, crossover (AB:BA) study aims to evaluate the safety, efficacy, and usability of Nanodropper-mediated microdrops of IOP-lowering medications (experimental intervention) compared to standard eyedrops of the same medications (active comparator) in open-angle glaucoma or ocular hypertension patients at Harborview Eye Institute, for which permission has been obtained. A pre-study visit will be held before the start of the trial in which participant clinical histories will be documented and an ocular examination will be performed. Patients will be enrolled in the study by satisfying all the inclusion and none of the exclusion criteria. This 6-month study will include three clinic visits: a baseline visit at t = 0, crossover visit at t = 3 months, and final visit at t = 6 months. At the baseline visit, patients will be randomly assigned to one of two treatment groups (1:1): Group 1 will administer standard eyedrops everyday for three months before crossing over to administering Nanodropper-mediated microdrops daily for three months and Group 2 will administer Nanodropper-mediated microdrops everyday for three months before crossing over to administering standard eyedrops daily for three months. At the visit that precedes the onset of the standard eyedrops treatment period, subjects will receive education on how to properly instill eyedrops. At the visit that precedes the onset of the Nanodropper treatment period, patients will receive education on how to properly instill eyedrops with the Nanodropper as well as one Nanodropper per bottle of prescription eyedrops. Patients will be instructed to use the Nanodropper with their bottle of eyedrops until the bottle is nearly depleted and they are due for a refill. Because the Nanodropper isn't reusable, subjects will be instructed to contact the clinic for additional Nanodroppers at the time that they refill their prescriptions. At each clinic visit, the IOP of each eye will be measured at 8 AM, 10 AM, and 12 PM using a calibrated Goldmann applanation tonometer by a masked evaluator. Additionally, surveys designed to assess whether Nanodropper impacts the financial burden and side effect profiles associated with chronic eyedrop use, as well as the usability of Nanodropper compared to standard eyedrop bottles, will be administered.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Simona Vuletic; Phone Number: 206-520-9728; Email: simona@uw.edu

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98104
      • Recruiting
      • University of Washington
      • Contact: Simona Vuletic, MD; Phone Number: 206-520-9728; Email: simona@uw.edu
      • Contact: Brian Gomer; Phone Number: 206-520-9728; Email: bgome001@uw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ≥18 years old
• Primary open-angle glaucoma (OAG) diagnosis
• Ocular hypertension (OHT) diagnosis
• Corneal thickness <600 µm
• Use 1-2 IOP-lowering eyedrop medications that are compatible with Nanodropper
• OAG/OHT must be well-controlled (defined as ≥2 IOP measurements collected within 6 months of recruitment that are ≤21 mm Hg with variability of ±3 mm Hg)
• OAG/OHT must be progression-free (as judged by the clinician and based on ≥2 stable OCT and visual field tests collected in the 6 months prior to recruitment)

Exclusion Criteria:

• Uncontrolled glaucoma (IOP >21 mmHg)
• Use of >2 medications for treatment of OAG/OHT
• Use of eyedrop medications that are incompatible with Nanodropper
• OAG/OHT progression (as judged by the clinician within the past 6 months)
• Eye surgery including laser procedures (e.g., SLT, iridotomy) within 6 months of recruitment
• Diagnosis of acute angle-closure glaucoma and/or other retinal diseases

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control; Standard eyedrops of IOP-lowering medications	Device: control; Patients will use their prescribed IOP-lowering medication using standard eyedropper on the medication bottle.
Experimental: Nanodropper; Microdrops of IOP-lowering medications using Nanodropper adaptor	Device: Nanodropper adaptor; Patients will use their standard prescription for open-angle glaucoma or ocular hypertension with a Nanodropper attachment on the medication bottle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IOP (mm Hg)	Mean IOP ± SEM following three months of treatment with each modality. The change in IOP from baseline and the percent change in IOP from baseline are supportive efficacy endpoints.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Survey scores of treatment-related adverse events that patients experience under each treatment modality will be compared	6 months
Premature bottle exhaustion	Survey scores of how frequently patients run out of their eyedrops before insurance will cover their next refill under each treatment modality will be compared	6 months
Socioeconomic strain	Survey scores of socioeconomic strain and the financial burden associated with chronic eyedrop use under each treatment modality will be compared	6 months

Collaborators and Investigators

• Sponsor: University of Washington
• Investigators: Principal Investigator: Raghu Mudumbai, University of Washington

Publications and helpful links

Helpful Links

• Nanodropper website

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2022
• Primary Completion (Anticipated): June 30, 2025
• Study Completion (Anticipated): June 30, 2025

Study Registration Dates

• First Submitted: March 3, 2022
• First Submitted That Met QC Criteria: March 3, 2022
• First Posted (Actual): March 14, 2022

Study Record Updates

• Last Update Posted (Actual): March 14, 2022
• Last Update Submitted That Met QC Criteria: March 3, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: ocular hypertension; glaucoma
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
• Other Study ID Numbers: STUDY00013248

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No