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

Ocular Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05844384
• Other study ID #: C.2022.041
• Status: Recruiting
• Phase: N/A
• Start date: March 17, 2022
• Est. completion date: March 17, 2024

Study information

• Verified date: April 2023
• Source: 59th Medical Wing
• Contact: Jose E Capo-Aponte, OD, PhD
• Phone: 210-292-2554
• Email: Jose.E.CapoAponte.ctr[@]health.mil
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 17, 2024
• Est. primary completion date: March 17, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Device:
• Nanodropper
Nanodropper delivers 1/5 of eye drop volume compared to regular droppers
• Regular dropper
Delivers full eye drop volume

Locations

Country	Name	City	State
United States	Wilford Hall Ambulatory Surgical Center	Lackland Air Force Base	Texas

Sponsors (2)

Lead Sponsor	Collaborator
59th Medical Wing	Nanodropper, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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