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

Study Overview
=================
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.

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

Conditions
-----------------
Ocular Hypertension, Primary Open Angle Glaucoma

Intervention / Treatment
-----------------
* Device: Nanodropper
* Device: Regular dropper


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Prospective, randomized, single-masked, active-controlled, crossover (AB:BA)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nanodroper<br>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<br>* Nanodropper delivers 1/5 of eye drop volume compared to regular droppers<br>|
| Active Comparator: Regular Dropper<br>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<br>* Delivers full eye drop volume<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Change from baseline to month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 to month 6 | 
| 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 to month 6 | 
| 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. | Change from baseline to month 6 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nanodropper, Primary Open Angle Glaucoma, Microdrops, Ocular Hypertension