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

Primary Purpose

Ocular Hypertension, Primary Open Angle Glaucoma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nanodropper
Regular dropper
Sponsored by
59th Medical Wing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Ocular Hypertension focused on measuring Nanodropper, Primary Open Angle Glaucoma, Microdrops, Ocular Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Wilford Hall Ambulatory Surgical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nanodroper

Regular Dropper

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change from baseline in mean intraocular pressure at 6 month
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 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 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 in the visual field mean deviation (unit = decibels) from baseline to month 6measure with Humphreys Visual Field Analyzer.

Full Information

First Posted
February 14, 2023
Last Updated
May 3, 2023
Sponsor
59th Medical Wing
Collaborators
Nanodropper, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05844384
Brief Title
Nanodropper Use in Primary Open-Angle Glaucoma Patients: A Non-Inferiority Trial
Official Title
Nanodropper Use in Primary Open-Angle Glaucoma Patients: A Non-Inferiority Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 17, 2022 (Actual)
Primary Completion Date
March 17, 2024 (Anticipated)
Study Completion Date
March 17, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
59th Medical Wing
Collaborators
Nanodropper, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Hypertension, Primary Open Angle Glaucoma
Keywords
Nanodropper, Primary Open Angle Glaucoma, Microdrops, Ocular Hypertension

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Prospective, randomized, single-masked, active-controlled, crossover (AB:BA)
Masking
Investigator
Masking Description
The investigators performing the vision assessment and measuring the intraocular pressure are masked.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nanodroper
Arm Type
Experimental
Arm Description
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
Arm Title
Regular Dropper
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Nanodropper
Intervention Description
Nanodropper delivers 1/5 of eye drop volume compared to regular droppers
Intervention Type
Device
Intervention Name(s)
Regular dropper
Intervention Description
Delivers full eye drop volume
Primary Outcome Measure Information:
Title
Change from baseline in mean intraocular pressure at 6 month
Description
Change in mean intraocular pressure (unit = mmHg) from baseline to month 6 measure with applanation tonometer
Time Frame
Change from baseline to month 6
Secondary Outcome Measure Information:
Title
Change from baseline in mean high contrast visual acuity at 6-month
Description
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.
Time Frame
Change from baseline to month 6
Title
Change from baseline in mean retinal nerve fiber layer thickness at 6-month
Description
Change in the mean retinal nerve fiber layer thickness (unit = micrometer) from baseline to month 6 measure with optical coherence tomographer.
Time Frame
Change from baseline to month 6
Title
Change from baseline in visual field mean deviation at 6-month
Description
Change in the visual field mean deviation (unit = decibels) from baseline to month 6measure with Humphreys Visual Field Analyzer.
Time Frame
Change from baseline to month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jose E Capo-Aponte, OD, PhD
Phone
210-292-2554
Email
Jose.E.CapoAponte.ctr@health.mil
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Steger, PhD
Phone
507-405-5676
Email
jenny@nanodropper.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandra Papp, MD
Organizational Affiliation
59th Medical Wing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wilford Hall Ambulatory Surgical Center
City
Lackland Air Force Base
State/Province
Texas
ZIP/Postal Code
78236
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose E Capo-Aponte, OD, PhD
Phone
210-292-2554
Email
Jose.E.CapoAponte.ctr@health.mil

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Result of the study will be published in a scientific journal upon completion.

Learn more about this trial

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

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