DilationNCT05274321

Efficacy of the Nanodropper Device on Pupillary Dilation

A study testing Nanodropper and Standard Eye Dropper in people with Dilation, run by University of California, San Francisco at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Prescription eye drop bottles elute drops that exceed the capacity of the human eye by five times. This study describes performing in clinic dilation using a novel solution for combating medical waste with Nanodropper, an eye drop bottle adapter that creates smaller eye drops. Read more about this study

Who is it for?: Ages 2 to 17 years
Conditions the study is for: Dilation
What is being tested?: Nanodropper and Standard Eye Dropper
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteUnited States
Study dates: 29 Jul 2021to 19 Nov 2021
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 2 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Participants under the age of 18 years old

Who cannot join

Participants 18 years and older
Pupillary or anterior segment abnormality
Participants with pre-existing health conditions that would prevent pupillary dilation.

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

Conditions: Dilation
Being tested: Nanodropper, Standard Eye Dropper
Medical subject headings: Dilatation, Pathologic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NanodropperDevice
Device used for administering eye drops
Standard Eye DropperDevice
Standard Eye Dropper used for administering eye drops

Study groups in NCT05274321
Study group	Role	What they receive
Pediatric Participant's Eyes Using Standard Pupilary Dilation	Active comparator	Consenting pediatric participants will undergo standard pupillary dilation in one eye. Receives: Device: Standard Eye Dropper
Pediatric Participant's Eyes using Nanodropper attachment	Experimental	Consenting pediatric participants will undergo pupillary dilation in the second eye using the Nanodropper attachment. Receives: Device: Nanodropper

What is being measured

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

Spherical Equivalent
Cycloplegia is the paralysis of the ciliary muscle of the eye resulting in dilatation of the pupil and paralysis of accommodation.
Cycloplegia is defined as the "change score." Change scores were calculated by subtracting the spherical equivalent value after dilation from the value before dilation for each eye.
Measured: Before dilation and 30 minutes after dilation
Maximum Pupil Diameter
The pupil is the opening in the center of the iris (the structure that gives our eyes their color). The diameter is a straight line passing from side to side through the center of the pupil, which is shaped like a circle.
Measured: Before dilation and 30 minutes after dilation
Constriction Percentage
Pupillary constriction percentage was calculated by the pupillometer in response to a 180-micro watt flash: (maximum - minimum) / maximum
Measured: Before and 30 minutes after dilation

Secondary outcomes (1)

Change in Intraocular Pressure
Intraocular pressure is the pressure, or force, inside of your eyes. Specifically, it's a measurement of the fluid pressure in your aqueous humor.
Measured: Before and 30 minutes After Dilation

Timeline

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

29 Jul 202119 Nov 2021

First posted10 Mar 2022
Study start29 Jul 2021
Primary completion19 Nov 2021
Study completion19 Nov 2021

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 DilationStudies 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: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05274321
Sponsor's protocol ID: 20-32530-OBS
Status last verified: Sep 2023
First submitted: 1 Mar 2022
Last updated: 25 Sep 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

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

RecruitingPhase 2/3
A Study of the Efficacy and Safety of Danicamtiv in Participants With Symptomatic Genetic and Familial Dilated Cardiomyopathy
Symptomatic Genetic Dilated Cardiomyopathy
RecruitingPhase 3
A Study of the Long-term Safety and Efficacy of Danicamtiv in Adults With Symptomatic Genetic and Familial Dilated Cardiomyopathy
Symptomatic Genetic Dilated Cardiomyopathy (DCM)
RecruitingObservational study
A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease
Coronary Artery Disease, Myocarditis
RecruitingPhase 1/2
An AAV Gene Therapy Trial of AFTX-201 in Adults With BAG3-Associated Dilated Cardiomyopathy (DCM)
Dilated Cardiomyopathy (DCM), BAG3 Mutation Associated Dilated Cardiomyopathy
Recruiting
SYMmetric Valve fraME Expansion To Reduce hYpoattenuated Leaflet Thickening After Balloon-expandable TAVI: the SYMMETRY Trial
Aortic Valve Stenosis and/or Insufficiency, Hypoattenuated Leaflet Thickening

All Dilation trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of the Nanodropper Device on Pupillary Dilation
ClinicalTrials.gov ID: NCT05274321
Acronym / sponsor ID: 20-32530-OBS
Conditions: Dilation
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: University of California, San FranciscoUniversity, hospital or other
Collaborators: Nanodropper, Inc.
Study start: 29 Jul 2021 (actual)
Primary completion: 19 Nov 2021 (actual)
Study completion: 19 Nov 2021 (actual)
First posted: 10 Mar 2022 (actual)
Results: Posted 25 Sep 2023

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Pediatric Participant's Eyes Using Standard Pupilary Dilation	Active comparator	Device: Standard Eye DropperConsenting pediatric participants will undergo standard pupillary dilation in one eye.
Pediatric Participant's Eyes using Nanodropper attachment	Experimental	Device: NanodropperConsenting pediatric participants will undergo pupillary dilation in the second eye using the Nanodropper attachment.

Who may qualify

Ages: 2 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (1 listed)

Participants under the age of 18 years old

Key exclusion criteria (3 listed)

Participants 18 years and older
Pupillary or anterior segment abnormality
Participants with pre-existing health conditions that would prevent pupillary dilation.

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 used for administering eye drops	Device	Pediatric Participant's Eyes using Nanodropper attachment
Standard Eye DropperStandard Eye Dropper used for administering eye drops	Device	Pediatric Participant's Eyes Using Standard Pupilary Dilation

Primary outcome

Spherical Equivalent
Time frame: Before dilation and 30 minutes after dilation
Cycloplegia is the paralysis of the ciliary muscle of the eye resulting in dilatation of the pupil and paralysis of accommodation. Cycloplegia is defined as the "change score." Change scores were calculated by subtracting the spherical equivalent value after dilation from the value before dilation for each eye.
Maximum Pupil Diameter
Time frame: Before dilation and 30 minutes after dilation
The pupil is the opening in the center of the iris (the structure that gives our eyes their color). The diameter is a straight line passing from side to side through the center of the pupil, which is shaped like a circle.
Constriction Percentage
Time frame: Before and 30 minutes after dilation
Pupillary constriction percentage was calculated by the pupillometer in response to a 180-micro watt flash: (maximum - minimum) / maximum

1 secondary outcome

Change in Intraocular Pressure
Time frame: Before and 30 minutes After Dilation

Results and safety

Results posted to the registry on 25 Sep 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Eyes Recieving Eye Drops From Standard of Care	50	50
Eyes Recieving Eye Drops Using Nanodropper Device	50	50

Primary outcome: Spherical Equivalent

Time frame: Before dilation and 30 minutes after dilation. Mean (95% Confidence Interval). Unit: Diopters

Measure	Eyes Recieving Eye Drops From Standard of Care n = 50	Eyes Recieving Eye Drops Using Nanodropper Device n = 50
Before Dilation	-2.62 (-3.59 to -1.65)	-2.28 (-3.17 to -1.39)
After Dilation	-0.86 (-1.75 to 0.03)	-0.55 (-1.43 to 0.34)
Change Score	1.76 (1.11 to 2.41)	1.73 (1.11 to 2.36)

Eyes Recieving Eye Drops From Standard of Care vs Eyes Recieving Eye Drops Using Nanodropper Device: p = 0.22, Regression, Linear

Population analysed: Participants received eye drops from the Nanodropper in one eye only and Standard of Care in the other eye.

Primary outcome: Maximum Pupil Diameter

Time frame: Before dilation and 30 minutes after dilation. Mean (95% Confidence Interval). Unit: mm

Measure	Eyes Recieving Eye Drops From Standard of Care n = 50	Eyes Recieving Eye Drops Using Nanodropper Device n = 50
Before Dilation	5.95 (5.76 to 6.14)	6.01 (5.80 to 6.22)
After Dilation	7.91 (7.72 to 8.10)	7.81 (7.61 to 8.01)
Change Score	1.95 (1.77 to 2.13)	1.77 (1.58 to 1.96)

Eyes Recieving Eye Drops From Standard of Care vs Eyes Recieving Eye Drops Using Nanodropper Device: p = 0.02, Regression, Linear

Population analysed: Participants received eye drops from the Nanodropper in one eye only and Standard of Care in the other eye.

Primary outcome: Constriction Percentage

Time frame: Before and 30 minutes after dilation. Mean (95% Confidence Interval). Unit: percent change

Measure	Eyes Recieving Eye Drops From Standard of Care n = 50	Eyes Recieving Eye Drops Using Nanodropper Device n = 50
Before Dilation	30.44 (28.95 to 31.93)	31.07 (29.53 to 32.61)
After Dilation	5.67 (3.21 to 8.14)	6.26 (4.35 to 8.17)
Change Score	-24.76 (-27.53 to -22.00)	-24.81 (-26.72 to -22.49)

Eyes Recieving Eye Drops From Standard of Care vs Eyes Recieving Eye Drops Using Nanodropper Device: p = 0.03, Regression, Linear

Population analysed: Participants received eye drops from the Nanodropper in one eye only and Standard of Care in the other eye.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data were collected during the time of the participant visit. Each participant visit lasted on average 1 hour.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Eyes Recieving Eye Drops From Standard of Care	0 of 50 (0%)	0 of 50 (0%)	0 of 50
Eyes Recieving Eye Drops Using Nanodropper Device	0 of 50 (0%)	0 of 50 (0%)	0 of 50

Limitations and caveats (from the sponsor): We chose a noninferiority margin of a loss of 10% of the treatment effect, which is more conservative than the 50% margin that has been recommended for some industry trials by the United States Food and Drug Administration. Study staff and participants were not masked to the intervention. Additionally, this cohort comprised predominantly children with dark irides but could limit the generalizability of these results. We did not measure minimizing systemic side effects and local irritation.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Dilation

RecruitingPhase 2/3
A Study of the Efficacy and Safety of Danicamtiv in Participants With Symptomatic Genetic and Familial Dilated Cardiomyopathy
Symptomatic Genetic Dilated Cardiomyopathy
RecruitingPhase 3
A Study of the Long-term Safety and Efficacy of Danicamtiv in Adults With Symptomatic Genetic and Familial Dilated Cardiomyopathy
Symptomatic Genetic Dilated Cardiomyopathy (DCM)
RecruitingObservational study
A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease
Coronary Artery Disease, Myocarditis
RecruitingPhase 1/2
An AAV Gene Therapy Trial of AFTX-201 in Adults With BAG3-Associated Dilated Cardiomyopathy (DCM)
Dilated Cardiomyopathy (DCM), BAG3 Mutation Associated Dilated Cardiomyopathy
Recruiting
SYMmetric Valve fraME Expansion To Reduce hYpoattenuated Leaflet Thickening After Balloon-expandable TAVI: the SYMMETRY Trial
Aortic Valve Stenosis and/or Insufficiency, Hypoattenuated Leaflet Thickening

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 and Standard Eye Dropper in people with Dilation, 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 25 Sep 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?

Yes. Results are posted in the registry (first posted 25 Sep 2023). 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?

Spherical Equivalent (time frame: Before dilation and 30 minutes after dilation). 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 NCT05274321.

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 25 Sep 2023.