Ocular HypertensionNCT05844384
Nanodropper Use in Primary Open-Angle Glaucoma Patients: A Non-Inferiority Trial
A study testing Nanodropper and Regular dropper in people with Ocular Hypertension and Primary Open Angle Glaucoma, run by 59th Medical Wing at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ocular Hypertension, Primary Open Angle Glaucoma
- What is being tested?
- Nanodropper and Regular dropper
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2022to 17 Mar 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Wilford Hall Ambulatory Surgical Center
Lackland Air Force Base, Texas, 78236
Jose E Capo-Aponte, OD, PhD, 210-292-2554, Jose.E.CapoAponte.ctr@health.mil
About this study
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.
Read the 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.
- Conditions
- Ocular Hypertension, Primary Open Angle Glaucoma
- Being tested
- Nanodropper, Regular dropper
- Keywords
- Nanodropper, Primary Open Angle Glaucoma, Microdrops, Ocular Hypertension
- Medical subject headings
- Ocular Hypertension, Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NanodropperDevice
Nanodropper delivers 1/5 of eye drop volume compared to regular droppers
Regular dropperDevice
Delivers full eye drop volume
| Study group | Role | What they receive |
|---|---|---|
| Nanodroper | Experimental | * 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 Receives: Device: Nanodropper |
| Regular Dropper | Active comparator | * 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 Receives: Device: Regular dropper |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from baseline to month 6
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Change from baseline to month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start17 Mar 2022
- Primary completion17 Mar 2024 (estimated)
- Study completion17 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ocular HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Prospective, randomized, single-masked, active-controlled, crossover (AB:BA)
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- 59th Medical Wing
- Sponsor type
- US federal agency
- Collaborators
- Nanodropper, Inc.
- Responsible party
- Sponsor
- Investigators
- Alexandra Papp, MD, Principal investigator, 59th Medical Wing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05844384
- Sponsor's protocol ID
- C.2022.041
- Status last verified
- Apr 2023
- First submitted
- 14 Feb 2023
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Result of the study will be published in a scientific journal upon completion.
Publications
Steger JS, Capo-Aponte JE, Papp A, Schulte AJ, Grewal EP, Song AJ, Colantuoni E, Kelstrom JC, Robin AL. Real-world efficacy, safety, and usability of a microvolume eyedrop delivery device in glaucoma: prospective randomized crossover trial. J Cataract Refract Surg. 2026 Apr 1;52(4):385-392. doi: 10.1097/j.jcrs.0000000000001823.
PubMed 41185150
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nanodropper Use in Primary Open-Angle Glaucoma Patients: A Non-Inferiority Trial
- ClinicalTrials.gov ID
- NCT05844384
- Acronym / sponsor ID
- C.2022.041
- Conditions
- Ocular Hypertension, Primary Open Angle Glaucoma
- Keywords
- Nanodropper, Primary Open Angle Glaucoma, Microdrops, Ocular Hypertension
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- 59th Medical WingUS federal agency
- Collaborators
- Nanodropper, Inc.
- Study start
- 17 Mar 2022 (actual)
- Primary completion
- 17 Mar 2024 (estimated)
- Study completion
- 17 Mar 2024 (estimated)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Prospective, randomized, single-masked, active-controlled, crossover (AB:BA)
| Arm | Type | Receives |
|---|---|---|
| Nanodroper | Experimental | Device: Nanodropper* 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 |
| Regular Dropper | Active comparator | Device: Regular dropper* 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NanodropperNanodropper delivers 1/5 of eye drop volume compared to regular droppers | Device | Nanodroper |
| Regular dropperDelivers full eye drop volume | Device | Regular Dropper |
Primary outcome
Change from baseline in mean intraocular pressure at 6 month
Time frame: Change from baseline to month 6
Change in mean intraocular pressure (unit = mmHg) from baseline to month 6 measure with applanation tonometer
3 secondary outcomes
Change from baseline in mean high contrast visual acuity at 6-month
Time frame: Change from baseline to month 6
Change from baseline in mean retinal nerve fiber layer thickness at 6-month
Time frame: Change from baseline to month 6
Change from baseline in visual field mean deviation at 6-month
Time frame: Change from baseline to month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Derived from this study: PubMed 41185150Steger JS, Capo-Aponte JE, Papp A, Schulte AJ, Grewal EP, Song AJ, Colantuoni E, Kelstrom JC, Robin AL. Real-world efficacy, safety, and usability of a microvolume eyedrop delivery device in glaucoma: prospective randomized crossover trial. J Cataract Refract Surg. 2026 Apr 1;52(4):385-392. doi: 10.1097/j.jcrs.0000000000001823.
- Individual participant dataSharing planned: No. Result of the study will be published in a scientific journal upon completion.
Related trials for Ocular Hypertension
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Anterior Segment Anatomy Assessed by Swept-Source OCT in Ocular Surgery Patients
Cataract, Primary Angle-Closure Glaucoma
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexandra Papp, MD principal investigator
59th Medical Wing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nanodropper and Regular dropper in people with Ocular Hypertension and Primary Open Angle Glaucoma, run by 59th Medical Wing at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jose E Capo-Aponte, OD, PhD (210-292-2554, Jose.E.CapoAponte.ctr@health.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in mean intraocular pressure at 6 month (time frame: Change from baseline to month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05844384, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.