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

Sponsor

59th Medical Wing (U.S. Fed)

Overall Status

Recruiting

CT.gov ID

NCT05844384

Collaborator

Nanodropper, Inc. (Industry)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Ocular Hypertension Primary Open Angle Glaucoma	Device: Nanodropper Device: Regular dropper	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

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

Masking:

Single (Investigator)

Masking Description:

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

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Mar 17, 2022

Anticipated Primary Completion Date :

Mar 17, 2024

Anticipated Study Completion Date :

Mar 17, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Device: Nanodropper Nanodropper delivers 1/5 of eye drop volume compared to regular droppers
Active Comparator: 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	Device: Regular dropper Delivers full eye drop volume

Arm

Intervention/Treatment

Experimental: 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

Device: Nanodropper

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

Active Comparator: 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

Device: Regular dropper

Delivers full eye drop volume

Outcome Measures

Primary Outcome Measures

Change from baseline in mean intraocular pressure at 6 month [Change from baseline to month 6]
Change in mean intraocular pressure (unit = mmHg) from baseline to month 6 measure with applanation tonometer

Secondary Outcome Measures

Change from baseline in mean high contrast visual acuity at 6-month [Change from baseline to month 6]
Change in the mean uncorrected visual acuity (unit = logMAR) from baseline to month 6 measure with ETDRS chart from baseline at 6 months post-op.
Change from baseline in mean retinal nerve fiber layer thickness at 6-month [Change from baseline to month 6]
Change in the mean retinal nerve fiber layer thickness (unit = micrometer) from baseline to month 6 measure with optical coherence tomographer.
Change from baseline in visual field mean deviation at 6-month [Change from baseline to month 6]
Change in the visual field mean deviation (unit = decibels) from baseline to month 6measure with Humphreys Visual Field Analyzer.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.