GlaucomaNCT05273385

Efficacy of the Nanodropper Device on Intraocular Pressure in Patients With Glaucoma

A study testing Nanodropper in people with Glaucoma and Ocular Hypertension, run by University of California, San Francisco at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Glaucoma, Ocular Hypertension, Open Angle Glaucoma
What is being tested?: Nanodropper
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteUnited States
Study dates: 10 Oct 2022to 10 Dec 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

18 years old or older
Diagnosis of open-angle glaucoma (OAG) or ocular hypertension (OHT)
Use of prostaglandin analogue (PGA) eye drop
Stable disease status (no visual field loss progression or increase in IOP-lowering medications in the last 6 months)

Who cannot join

Uncontrolled glaucoma
Have had eye surgery (including laser procedures) within the past six months
Have a diagnosis of acute angle-closure glaucoma and/or other retinal diseases
Use of non-PGA class of IOP-lowering medication

Trial locations and contacts

1 site in 1 country.

United States1 site

University of California, San Francisco
San Francisco, California, 94143

Other trials in United States

About this study

Glaucoma is the leading cause of irreversible blindness worldwide. Previous studies demonstrate that smaller eye drops used in the treatment of glaucoma are just as efficacious as their larger counterparts. The proposed study hopes to demonstrate the non-inferiority of using Nanodropper to lower intraoccular pressure (IOP) in glaucoma patients compared to standard of care eye drops.

Read the detailed description

The proposed study strives to demonstrate the non-inferiority of using Nanodropper to lower IOP in glaucoma patients compared to standard of care (SOC) eye drops in a randomized trial.

Primary Aim: Demonstrate non-inferiority of using Nanodropper to lower IOP compared to standard of care eye drops in glaucoma patients.

Stable glaucoma participants and ocular hypertension participants of ages 18+ will be randomized to either use Nanodropper for eye drop administration in both eyes OR administer drops regularly (standard of care) in both eyes. Participants will be followed-up at 1 month and 3 months.

Conditions: Glaucoma, Ocular Hypertension, Open Angle Glaucoma
Being tested: Nanodropper
Medical subject headings: Glaucoma, 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
Device to apply liquid medication to eyes

Study groups in NCT05273385
Study group	Role	What they receive
Nanodropper	Experimental	Participants will receive the Nanodropper with instructions and attend clinic visits at baseline, 1, and 3 months. Participants will administer their eye drops using the Nanodropper. Receives: Device: Nanodropper
Standard of Care Dropper	No intervention	Participants will receive standard of care eye dropper with instructions and attend clinic visits at baseline, 1, and 3 months. Participants will administer their eye drops using the standard of care eye dropper.

What is being measured

The primary outcome is the main question the study is designed to answer.

Intraocular Pressure (IOP) at Baseline
IOP measurement of the eye will be collected at the baseline visit using routine methods including Goldman applanation tonometry and pneumotonometer.
Measured: At Baseline
Intraocular Pressure (IOP) at Month 1
IOP measurement of the eye will be collected at the Month 1 visit using routine methods including Goldman applanation tonometry and pneumotonometer.
Measured: 1 month
Intraocular Pressure (IOP) at Month 3
IOP measurement of the eye will be collected at the month 3 visit using routine methods including Goldman applanation tonometry and pneumotonometer.
Measured: 3 months

Secondary outcomes (3)

Survey
The following open-ended questions will be administered to participants randomized to the Nanodropper group at the end of the 3-month study.
1. Would you consider using the Nanodropper for your regular eye drop use in the future? (yes/no)
2. Did you find the Nanodropper easy to use? (yes/no)
3. Did using the Nanodropper cause more irritation compared to normal eye drop bottles? (yes/no)
Measured: 3 months
Conjunctival Grading at Baseline
Conjunctival grading will be performed by a masked ophthalmologist at the baseline study visit. Grading will be performed with redness graded on a scale of 0-100 using the bulbar redness 5-picture validated scale. A grade of 0 is considered to be the least red and therefore a better outcome. A grade of 100 is considered the most red and therefore a worse outcome.
Measured: At baseline
Conjunctival Grading at Month 3
Conjunctival grading will be performed by a masked ophthalmologist the 3 month study visit. Grading will be performed with redness graded on a scale of 0-100 using the bulbar redness grading 5-picture validated scale. A grade of 0 is considered to be the least red and therefore a better outcome. A grade of 100 is considered the most red and therefore a worse outcome.
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Oct 202210 Dec 2024

First posted10 Mar 2022
Study start10 Oct 2022
Primary completion10 Dec 2024
Study completion10 Dec 2024

Why it stopped: A similar study has been published by other groups and this study is no longer needed.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for GlaucomaStudies of the same condition, open and under way.
More trials run by University of California, San FranciscoThe sponsor's other registered studies.
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: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05273385
Sponsor's protocol ID: 20-32530
Status last verified: Mar 2026
First submitted: 1 Mar 2022
Last updated: 5 Mar 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes: Individual participant data that underlie the results after deidentification(text, tables, figures, and appendices).

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of the Nanodropper Device on Intraocular Pressure in Patients With Glaucoma
ClinicalTrials.gov ID: NCT05273385
Acronym / sponsor ID: 20-32530
Conditions: Glaucoma, Ocular Hypertension, Open Angle Glaucoma
Study type: Interventional
Recruitment status: TerminatedReason stopped: A similar study has been published by other groups and this study is no longer needed.
Enrolment: 16 participants (actual)
Lead sponsor: University of California, San FranciscoUniversity, hospital or other
Collaborators: Icare Finland Oy, Nanodropper, Inc.
Study start: 10 Oct 2022 (actual)
Primary completion: 10 Dec 2024 (actual)
Study completion: 10 Dec 2024 (actual)
First posted: 10 Mar 2022 (actual)
Results: Posted 5 Mar 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The proposed study strives to demonstrate the non-inferiority of using Nanodropper to lower IOP in glaucoma patients compared to standard of care (SOC) eye drops in a randomized trial.

Primary Aim: Demonstrate non-inferiority of using Nanodropper to lower IOP compared to standard of care eye drops in glaucoma patients.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Nanodropper	Experimental	Device: NanodropperParticipants will receive the Nanodropper with instructions and attend clinic visits at baseline, 1, and 3 months. Participants will administer their eye drops using the Nanodropper.
Standard of Care Dropper	No intervention	–Participants will receive standard of care eye dropper with instructions and attend clinic visits at baseline, 1, and 3 months. Participants will administer their eye drops using the standard of care eye dropper.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

18 years old or older
Diagnosis of open-angle glaucoma (OAG) or ocular hypertension (OHT)
Use of prostaglandin analogue (PGA) eye drop
Stable disease status (no visual field loss progression or increase in IOP-lowering medications in the last 6 months)

Key exclusion criteria (4 listed)

Uncontrolled glaucoma
Have had eye surgery (including laser procedures) within the past six months
Have a diagnosis of acute angle-closure glaucoma and/or other retinal diseases
Use of non-PGA class of IOP-lowering medication

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
NanodropperDevice to apply liquid medication to eyes	Device	Nanodropper

Primary outcome

Intraocular Pressure (IOP) at Baseline
Time frame: At Baseline
IOP measurement of the eye will be collected at the baseline visit using routine methods including Goldman applanation tonometry and pneumotonometer.
Intraocular Pressure (IOP) at Month 1
Time frame: 1 month
IOP measurement of the eye will be collected at the Month 1 visit using routine methods including Goldman applanation tonometry and pneumotonometer.
Intraocular Pressure (IOP) at Month 3
Time frame: 3 months
IOP measurement of the eye will be collected at the month 3 visit using routine methods including Goldman applanation tonometry and pneumotonometer.

3 secondary outcomes

Survey
Time frame: 3 months
Conjunctival Grading at Baseline
Time frame: At baseline
Conjunctival Grading at Month 3
Time frame: 3 months

Results and safety

Results posted to the registry on 5 Mar 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard of Care	10	7
Nanodropper	6	6

Primary outcome: Intraocular Pressure (IOP) at Baseline

Time frame: At Baseline. Mean (Standard Deviation). Unit: mmHg

Measure	Nanodropper n = 6	Standard of Care Dropper n = 7
Goldmann Right Eye	21.1 (4.0)	18.4 (4.5)
Goldmann Left Eye	20.1 (3.6)	19.3 (5.9)
Pneumotonometer Right Eye	21.3 (4.1)	20.1 (7.2)
Pneumotonometer Left Eye	22.6 (4.3)	20.6 (6.9)

Population analysed: Only patients with completed data was analyzed.

Primary outcome: Intraocular Pressure (IOP) at Month 1

Time frame: 1 month. Mean (Standard Deviation). Unit: mmHg

Measure	Nanodropper n = 6	Standard of Care Dropper n = 7
Goldmann Right Eye	17.4 (3.7)	16.5 (4.8)
Goldmann Left Eye	16.9 (2.8)	16.8 (4.3)
Pneumotonometer Right Eye	17.5 (3.3)	18.9 (4.2)
Pneumotonometer Left Eye	18.1 (3.0)	19.2 (3.8)

Population analysed: Only patients with completed data was analyzed.

Primary outcome: Intraocular Pressure (IOP) at Month 3

Time frame: 3 months. Mean (Standard Deviation). Unit: mmHg

Measure	Nanodropper n = 6	Standard of Care Dropper n = 7
Goldmann Right Eye	16.7 (3.3)	14.6 (4.3)
Goldmann Left Eye	16.3 (2.9)	14.6 (4.3)
Pneumotonometer Right Eye	17.2 (1.4)	17.6 (4.2)
Pneumotonometer Left Eye	17.6 (2.2)	17.3 (3.4)

Population analysed: Only data from participants who completed all visits were analyzed.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: from enrollment until end of follow-up, up to 13 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard of Care	0 of 7 (0%)	0 of 7 (0%)	0 of 7
Nanodropper	0 of 6 (0%)	0 of 6 (0%)	0 of 6

Limitations and caveats (from the sponsor): This study was terminated due to low enrollment numbers.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Individual participant data that underlie the results after deidentification(text, tables, figures, and appendices).

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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. This study is not recruiting at the moment.

Julius Oatts, MD principal investigator

University of California, San Francisco

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 in people with Glaucoma and Ocular Hypertension, run by University of California, San Francisco 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 4 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: stopped early, as of the sponsor's last update on 5 Mar 2026. 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?

Yes. Results are posted in the registry (first posted 5 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intraocular Pressure (IOP) at Baseline (time frame: At Baseline). The study lists 3 primary outcomes in all. 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 NCT05273385.

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 5 Mar 2026.