Health TrialsbyHealthPanel

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

ConditionsOcular HypertensionPrimary Open Angle Glaucoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
Sponsor59th Medical Wing

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Nanodropper

    Device

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

  • Regular dropper

    Device

    Delivers full eye drop volume

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: NanodroperExperimental treatment 1 intervention
Group B: Regular DropperActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Change from baseline to month 6

Secondary outcomes

1

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.

Time frame
Change from baseline to month 6
2

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.

Time frame
Change from baseline to month 6
3

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.

Time frame
Change from baseline to month 6

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

59th Medical Wing

Lead sponsor

Nanodropper, Inc.

Collaborator

Source ClinicalTrials.gov
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