Nanodropper Use in Primary Open-Angle Glaucoma Patients: A Non-Inferiority Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-17

Study Completion Date

2024-03-17

Brief Summary

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This randomized, single-masked, crossover, non-inferiority trial aims to evaluate the safety and efficacy of Nanodropper-mediated microdrops of ocular hypotensive topical treatments (experimental intervention) compared to standard drops of the same medication(s) (active comparator) in Wilford Hall Ambulatory Surgical Center (WHASC) primary open-angle glaucoma (POAG) and ocular hypertension (OHTN) patients.

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Detailed Description

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The primary objective of this study is to compare changes in intraocular pressure (IOP) in a population of POAG and OHTN patients in response to administration of 1) standard drops of IOP lowering medications and 2) Nanodropper-mediated microdrops of IOP-lowering medications. The hypothesis is that Nanodropper-mediated microdrops of IOP-lowering medications will not result in a significant difference in IOP relative to standard drops of IOP-lowering medications after three months of daily eyedrop administration with each delivery system. The primary outcome measure for this efficacy endpoint will be mean IOP (mm Hg) ± SEM. A secondary objective of this trial is to evaluate Nanodropper's safety and usability. Surveys that have been designed to gain an understanding of the differences in side effects and usability between using Nanodropper-mediated microdrops compared to standard eyedrops will be administered to patients at the enrollment visit and at each follow-up visit.

Conditions

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Ocular Hypertension Primary Open Angle Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Prospective, randomized, single-masked, active-controlled, crossover (AB:BA)

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators

The investigators performing the vision assessment and measuring the intraocular pressure are masked.

Study Groups

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Nanodroper

* Patients are given a Nanodropper to use with their IOP-lowering eyedrops.
* Patient returns for a safety check 1 month following the start of Nanodropper use.
* At 3 months, the patient returns for clinical assessment and starts using IOP-lowering eyedrops without Nanodropper for 3 months.
* The patient returns at 6 months for final clinical assessment

Group Type EXPERIMENTAL

Nanodropper

Intervention Type DEVICE

Nanodropper delivers 1/5 of eye drop volume compared to regular droppers

Regular Dropper

* Patient continues using current IOP-lowering eyedrops without Nanodropper adaptor.
* At 3 months, the patient returns for clinical assessment and starts using IOP-lowering eyedrops with Nanodropper for 3 months.
* Patient returns for a safety check 1 month following the start of Nanodropper use.
* The patient returns at 6 months for final clinical assessment

Group Type ACTIVE_COMPARATOR

Regular dropper

Intervention Type DEVICE

Delivers full eye drop volume

Interventions

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Nanodropper

Nanodropper delivers 1/5 of eye drop volume compared to regular droppers

Intervention Type DEVICE

Regular dropper

Delivers full eye drop volume

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* POAG/OHTN patients above the age of 18 years.
* On a maximum of 2 IOP lowering medications.
* Stable disease without progression in IOP, optic disc cupping, RNFL changes, and visual field changes within the previous 1 year.

Exclusion Criteria

* Glaucoma not of the POAG or OHTN variety or other retinal diseases.
* Progression of disease within the preceding 1 year (IOP elevation, optic disc cupping, visual field changes).
* Using more than 2 IOP-lowering medications.
* IOP-lowering surgical interventions or lasers except for SLT. SLT may have been completed 6+ months prior to study start date.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No