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

Not Applicable

Recruiting

• Conditions: Primary Open Angle Glaucoma; Ocular Hypertension

• Registration Number: NCT05844384
• Lead Sponsor: 59th Medical Wing

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.

Study Timeline

• Study Start: 2022-03-17
• Study First Submitted: 2023-02-14
• Status Verified: 2023-04
• Study First Submitted QC: 2023-05-03
• Last Update Submitted: 2023-05-03
• Study First Posted: 2023-05-06
• Last Update Posted: 2023-05-06
• Primary Completion: 2024-03-17
• Study Completion: 2024-03-17

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Wilford Hall Ambulatory Surgical Center; 🇺🇸 Lackland Air Force Base, Texas, United States