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

Sponsor
University of Washington (Other)
Overall Status
Recruiting
CT.gov ID
NCT05277870
Collaborator
(none)
150
1
2
40
3.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Nanodropper adaptor
  • Device: control
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
crossover assignmentcrossover assignment
Masking:
Single (Investigator)
Masking Description:
single
Primary Purpose:
Supportive Care
Official Title:
Use of Nanodropper vs. Standard Eyedropper in Patients With Glaucoma and Ocular Hypertension
Actual Study Start Date :
Feb 28, 2022
Anticipated Primary Completion Date :
Jun 30, 2025
Anticipated Study Completion Date :
Jun 30, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. IOP (mm Hg) [6 months]

    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.

Secondary Outcome Measures

  1. Adverse events [6 months]

    Survey scores of treatment-related adverse events that patients experience under each treatment modality will be compared

  2. Premature bottle exhaustion [6 months]

    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

  3. Socioeconomic strain [6 months]

    Survey scores of socioeconomic strain and the financial burden associated with chronic eyedrop use under each treatment modality will be compared

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Washington Seattle Washington United States 98104

Sponsors and Collaborators

  • University of Washington

Investigators

  • Principal Investigator: Raghu Mudumbai, University of Washington

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Raghu Mudumbai, Associate Professor: Ophthalmology, University of Washington
ClinicalTrials.gov Identifier:
NCT05277870
Other Study ID Numbers:
  • STUDY00013248
First Posted:
Mar 14, 2022
Last Update Posted:
Mar 14, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Raghu Mudumbai, Associate Professor: Ophthalmology, University of Washington
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 14, 2022