Medication DeliveryNCT06689904
The Effect of Eyedrop Size on Pupillary Dilation Using the Nanodropper Bottle Adapter
A study testing Nanodropper and Standard eye drop bottle in people with Medication Delivery and Eye Drop Delivery, run by Sutter Health at 1 site in United States.
Trial summary
The average drop size produced by standard eyedrop bottle exceeds the maximal capacity that the human eye are absorb topically. This excess leads to medication waste, increased costs, and greater risk of side effects. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Medication Delivery, Eye Drop Delivery
- What is being tested?
- Nanodropper and Standard eye drop bottle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2022to 31 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age >18 years old
- scheduled for routine bilateral eye dilation
Who cannot join
- narrow angles
- allergies to phenylephrine or tropicamide
- concurrent use of any mydriatic agents (e.g., atropine, cyclopentolate, brimonidine)
- baseline anisocoria (>1 mm)
- traumatic pupil,
- surgical pupil
- unilateral pseudoexfoliation.
Trial locations and contacts
1 site in 1 country.
About this study
The average drop size produced by standard eyedrop bottle exceeds the maximal capacity that the human eye are absorb topically. This excess leads to medication waste, increased costs, and greater risk of side effects.
The Nanodropper is a commercially available, FDA listed eyedrop bottle adapter that delivers a smaller drop size. The investigators hypothesize the Nanodropper is noninferior to the standard eye drop bottle for pupil dilation.
In this study, participants have one eye randomly chosen to be dilated with the Nanodropper and the fellow eye dilated with the standard bottle with a 50/50 mixture of tropicamide 1% and phenylephrine 2.5%. Pupil size before and after 30 minutes of dilation are measured with a pupillometer and compared between fellow eyes to see if there is a difference.
Read the detailed description
Ophthalmic medications are available in eyedrop bottles that produce on average a drop size of about 40 uL, while the human eye can only hold about 7-10uL. This excess leads to medication waste, increased costs, and greater risk of side effects.
The Nanodropper is a commercially available, FDA listed (class 1 medical device, 510(k) exempt) eyedrop bottle adapter that delivers a smaller drop size of 10 uL. The investigators hypothesize the Nanodropper is noninferior to the standard eye drop bottle for pupil dilation.
This is a prospective comparative matched pairs study of adults scheduled for routine bilateral eye dilation. Exclusion criteria includes anisocoria and medications affecting pupil size. One eye is randomly dilated with the Nanodropper and the fellow eye dilated with the standard bottle with a 50/50 mixture of tropicamide 1% and phenylephrine 2.5%. Pupil size before and after 30 minutes of dilation are measured with a pupillometer and compared between fellow eyes within the same subject with a noninferiority margin of 0.5mm.
- Conditions
- Medication Delivery, Eye Drop Delivery
- Being tested
- Nanodropper, Standard eye drop bottle
- Keywords
- eye drops, pupil dilation, eye drop bottle device, eye drop size
- Medical subject headings
- Mydriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NanodropperDevice
One eye is randomly selected to be dilated with the nanodropper
Standard eye drop bottleDevice
eye is dilated with the standard eye drop bottle
| Study group | Role | What they receive |
|---|---|---|
| Eye dilated with the nanodropper | Experimental | For each participant, one eye (left or right) is randomly selected to be dilated with the Nanodropper. Receives: Device: Nanodropper |
| Eye dilated with the standard bottle | Active comparator | Fellow eye is dilated with the standard eye drop bottle Receives: Device: Standard eye drop bottle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pupil size (diameter)
Pupil diameter (mm)
Measured: 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.
- First posted15 Nov 2024
- Study start4 Jan 2022
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication DeliveryStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sutter Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06689904
- Sponsor's protocol ID
- 1826733-1
- Status last verified
- Nov 2024
- First submitted
- 7 Nov 2024
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Eyedrop Size on Pupillary Dilation Using the Nanodropper Bottle Adapter
- ClinicalTrials.gov ID
- NCT06689904
- Acronym / sponsor ID
- 1826733-1
- Conditions
- Medication Delivery, Eye Drop Delivery
- Keywords
- eye drops, pupil dilation, eye drop bottle device, eye drop size
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Sutter HealthUniversity, hospital or other
- Study start
- 4 Jan 2022 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 15 Nov 2024 (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.
The average drop size produced by standard eyedrop bottle exceeds the maximal capacity that the human eye are absorb topically. This excess leads to medication waste, increased costs, and greater risk of side effects.
The Nanodropper is a commercially available, FDA listed eyedrop bottle adapter that delivers a smaller drop size. The investigators hypothesize the Nanodropper is noninferior to the standard eye drop bottle for pupil dilation.
In this study, participants have one eye randomly chosen to be dilated with the Nanodropper and the fellow eye dilated with the standard bottle with a 50/50 mixture of tropicamide 1% and phenylephrine 2.5%. Pupil size before and after 30 minutes of dilation are measured with a pupillometer and compared between fellow eyes to see if there is a difference.
Detailed description
Ophthalmic medications are available in eyedrop bottles that produce on average a drop size of about 40 uL, while the human eye can only hold about 7-10uL. This excess leads to medication waste, increased costs, and greater risk of side effects.
The Nanodropper is a commercially available, FDA listed (class 1 medical device, 510(k) exempt) eyedrop bottle adapter that delivers a smaller drop size of 10 uL. The investigators hypothesize the Nanodropper is noninferior to the standard eye drop bottle for pupil dilation.
This is a prospective comparative matched pairs study of adults scheduled for routine bilateral eye dilation. Exclusion criteria includes anisocoria and medications affecting pupil size. One eye is randomly dilated with the Nanodropper and the fellow eye dilated with the standard bottle with a 50/50 mixture of tropicamide 1% and phenylephrine 2.5%. Pupil size before and after 30 minutes of dilation are measured with a pupillometer and compared between fellow eyes within the same subject with a noninferiority margin of 0.5mm.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eye dilated with the nanodropper | Experimental | Device: NanodropperFor each participant, one eye (left or right) is randomly selected to be dilated with the Nanodropper. |
| Eye dilated with the standard bottle | Active comparator | Device: Standard eye drop bottleFellow eye is dilated with the standard eye drop bottle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age >18 years old
- scheduled for routine bilateral eye dilation
Key exclusion criteria (7 listed)
- narrow angles
- allergies to phenylephrine or tropicamide
- concurrent use of any mydriatic agents (e.g., atropine, cyclopentolate, brimonidine)
- baseline anisocoria (>1 mm)
- traumatic pupil,
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 |
|---|---|---|
| NanodropperOne eye is randomly selected to be dilated with the nanodropper | Device | Eye dilated with the nanodropper |
| Standard eye drop bottleeye is dilated with the standard eye drop bottle | Device | Eye dilated with the standard bottle |
Primary outcome
Pupil size (diameter)
Time frame: 30 minutes after dilation
Pupil diameter (mm)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
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 drop bottle in people with Medication Delivery and Eye Drop Delivery, run by Sutter Health 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 2 inclusion and 7 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 15 Nov 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pupil size (diameter) (time frame: 30 minutes after dilation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Nov 2024; AzTrials last refreshed its copy on 6 Nov 2026.