Nanodropper Adaptor for Glaucoma

Overseen By Simona Vuletic, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Must be taking: IOP-lowering eyedrops

Must not be taking: Incompatible eyedrops

Disqualifiers: Uncontrolled glaucoma, Eye surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special eyedrop bottle adaptor called Nanodropper for individuals with open-angle glaucoma or ocular hypertension (high eye pressure). The goal is to determine if using smaller eyedrops with the Nanodropper is safe, effective, and easy. Participants will use either the standard eyedrops or the new microdrops with the Nanodropper. Suitable candidates have open-angle glaucoma or ocular hypertension well-controlled with 1-2 compatible eye medications. As an unphased trial, this study allows participants to contribute to innovative research that could enhance treatment options for eye conditions.

Will I have to stop taking my current medications?

You can continue taking your current eyedrop medications if you use 1-2 types that are compatible with the Nanodropper. If you use more than 2 medications or any that are incompatible, you may need to stop or switch them.

What prior data suggests that this eyedrop bottle adaptor is safe for glaucoma patients?

Research shows that the Nanodropper adaptor is safe for people with glaucoma. One study with 419 patients tested the Nanodropper's ability to deliver smaller eyedrops safely. The results confirmed that using the Nanodropper for smaller drops was safe. Another study also verified that the Nanodropper can significantly reduce drop size while remaining safe and effective.

These findings suggest that the Nanodropper is well-tolerated and does not cause major safety issues. The research indicates that this tool could help manage glaucoma effectively while reducing the risk of side effects from excessive medication in each drop. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Nanodropper adaptor because it offers a new delivery method for glaucoma treatment. Unlike traditional eye drops that can be wasteful and lead to inconsistent dosing, the Nanodropper adaptor dispenses medication in microdrops. This innovative approach helps ensure more precise dosing and can potentially reduce medication waste, making treatments more efficient and cost-effective for patients.

What evidence suggests that the Nanodropper adaptor is effective for glaucoma?

Research has shown that the Nanodropper adaptor, which participants in this trial may receive, effectively treats open-angle glaucoma and high eye pressure. Studies have found that using the Nanodropper to administer smaller medication drops can significantly reduce eye pressure. For instance, one study reported a reduction in eye pressure by about 20% to nearly 30% within a few hours of using these smaller drops. Additionally, the Nanodropper’s smaller drops may cause fewer side effects compared to regular eye drops, making it a promising option for managing glaucoma or high eye pressure. Meanwhile, the control arm in this trial will use standard eye drops of IOP-lowering medications. ^{2 3 6 7 8}

Who Is on the Research Team?

Raghu Mudumbai

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

This trial is for adults over 18 with well-controlled open-angle glaucoma or ocular hypertension, meaning their eye pressure has been stable and not too high. They should be using 1-2 compatible eyedrop medications and have a corneal thickness less than 600 µm. People with uncontrolled glaucoma, on more than two medications, or recent eye surgery can't participate.

Inclusion Criteria

My eye pressure has been stable and below 21 mm Hg recently.

I use 1-2 eye drops that work with Nanodropper for my eye pressure.

I have been diagnosed with open-angle glaucoma.

Exclusion Criteria

I have been diagnosed with acute angle-closure glaucoma or another retinal disease.

I use eyedrops that cannot be used with a Nanodropper.

My eye pressure is not higher than 21 mmHg.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Pre-study Visit

Participant clinical histories documented and ocular examination performed

1 day

1 visit (in-person)

Treatment

Participants receive either standard eyedrops or Nanodropper-mediated microdrops for 3 months, then crossover to the other treatment for another 3 months

6 months

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Control
• Nanodropper adaptor

Trial Overview The study is testing the Nanodropper adaptor against standard eyedroppers in patients with glaucoma or ocular hypertension. The goal is to see if the Nanodropper, which makes smaller drops, is safe, effective, and user-friendly compared to regular droppers.

How Is the Trial Designed?

Group I: Nanodropper Experimental Treatment 1 Intervention

Microdrops of IOP-lowering medications using Nanodropper adaptor

Group II: control Active Control 1 Intervention

Standard eyedrops of IOP-lowering medications

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

Published Research Related to This Trial

In a study involving 50 glaucoma patients, the nose-pivoted drop delivery device (NPDD) was preferred by 94% of participants over traditional eye drop methods, indicating a significant improvement in user satisfaction and ease of use.

The NPDD not only reduced the number of eye drops wasted but also increased the success rates of accurate drop placement (86% vs. 66% for traditional methods) and minimized contact with the eye, enhancing overall safety during administration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel Eye Drop Delivery Aid Improves Outcomes and Satisfaction. Sanchez, FG., Mansberger, SL., Kung, Y., et al.[2021]

Topical microdosing of latanoprost using a high-precision delivery system significantly reduced intraocular pressure (IOP) by 26% and 30% after 1 and 2 days, respectively, while using 75% less drug and preservatives compared to conventional eyedropper methods.

The microdosing technique was well tolerated by all 30 healthy volunteers, with no adverse events reported, indicating a safer alternative for glaucoma treatment that minimizes the risk of ocular side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Latanoprost with high precision, piezo-print microdose delivery for IOP lowering: clinical results of the PG21 study of 0.4 µg daily microdose. Pasquale, LR., Lin, S., Weinreb, RN., et al.[2022]

In a study of 104 eyes over one year, the PreserFlo MicroShunt glaucoma device demonstrated a complete success rate of 51.9% and an overall success rate of 68.3%, significantly reducing intraocular pressure (IOP) from an average of 23.4 mmHg to 14.7 mmHg (p<0.0001).

The device also led to a substantial decrease in the need for antiglaucoma medications, from an average of 3.4 medications preoperatively to 0.7 at 12 months (p<0.0001), with a relatively low rate of complications such as hypotony (19.2%) and choroidal detachments (10.6%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-year surgical outcomes of the PreserFlo MicroShunt in glaucoma: a multicentre analysis. Tanner, A., Haddad, F., Fajardo-Sanchez, J., et al.[2023]

In a study of 100 glaucoma patients over one year, the Preserflo™ Microshunt demonstrated a qualified success rate of 74% and a complete success rate of 58% when aiming for an intraocular pressure (IOP) of ≤21 mmHg with a ≥20% reduction from baseline.

The procedure was found to be safe, with no hypotony-related complications, and it significantly reduced the need for glaucoma medications from an average of 3 to 0, although success rates were lower for more stringent IOP targets.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term safety and efficacy of Preserflo™ Microshunt in glaucoma patients: a multicentre retrospective cohort study. Bhayani, R., Martínez de la Casa, JM., Figus, M., et al.[2023]

The device dropper (DD) method for administering glaucoma medication was significantly easier and more accurate than the conventional drop instillation (CDI) method, with no reported difficulties in the DD group compared to 57.1% in the CDI group.

Both methods achieved comparable intraocular pressure (IOP) control, but the DD method reduced spillage and contamination, suggesting it may improve patient compliance and effectiveness in managing glaucoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Clinical Trial to Compare Conventional Drug Instillation to A Device Dropper Method in Medical Treatment of Glaucoma. Rajendrababu, S., Kannan, S., More, S., et al.[2022]

A meta-analysis of 28 randomized clinical trials involving 6953 participants found that bimatoprost, travoprost, latanoprost, and timolol are the most effective medications for reducing intraocular pressure (IOP) in patients with primary open-angle glaucoma and ocular hypertension.

The study reported significant IOP reductions, with peak reductions of up to -33% for bimatoprost and -31% for travoprost, compared to only -5% for placebo, indicating these treatments are much more effective than no treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraocular pressure-lowering effects of all commonly used glaucoma drugs: a meta-analysis of randomized clinical trials. van der Valk, R., Webers, CA., Schouten, JS., et al.[2022]

The study evaluated the effectiveness of a small-volume eye drop adapter, the Nanodropper, in achieving pupillary dilation in children, finding that it met noninferiority for maximum pupil diameter compared to the standard 50 μl eye drops, indicating it can be an effective alternative.

While the Nanodropper did not achieve noninferiority for cycloplegia or constriction percentage, the differences observed were small and not clinically significant, suggesting that using smaller volumes can reduce waste and toxicity without compromising therapeutic effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Trial to Evaluate the Efficacy of the Nanodropper Device for Pupillary Dilation and Cycloplegia in Children. Hoppe, CB., Yonamine, S., Kao, BW., et al.[2023]

The Nanodropper eyedrop bottle adaptor significantly reduces the volume of each drop by 62.1%, delivering an average of 15.1 μL per drop compared to 39.8 μL from standard bottles, which could help limit ocular toxicity.

Using the adaptor allows for 2.6 times more drops to be dispensed from a standard 2.5 mL bottle, increasing the total number of doses available, which may enhance treatment adherence and reduce waste.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction of Eyedrop Volume for Topical Ophthalmic Medications with the Nanodropper Bottle Adaptor. St Peter, DM., Steger, JS., Patnaik, JL., et al.[2023]

Citations

1. glance.eyesoneyecare.com glance.eyesoneyecare.com/stories/2024-03-22/study-finds-nanodropper-adaptor-demonstrates-efficacy-and-safety-as-glaucoma-treatment/

Study finds Nanodropper Adaptor demonstrates efficacy ... Study finds Nanodropper Adaptor demonstrates efficacy and safety as glaucoma treatment ... data was missing, 419 patients were included in ...

2. nanodropper.com nanodropper.com/clinical-data-summary

Clinical Data Summary Efficacy of IOP-Lowering Microdrops Administered with the Nanodropper® Adaptor in. Glaucoma Patients. Steger JS, Capó-Aponte JE, Papp A, Schulte AJ, Song AJ ...

3. eyeworld.org eyeworld.org/2024/bottle-adapter-reduces-negative-side-effect-profile-and-maintains-positive-iop-reduction/

Bottle adapter reduces negative side effect profile and ... The Nanodropper Adaptor is a screw-on cap that delivers a smaller drop of medication, which could be associated with a decreased side effect profile.

4. ophthalmologytimes.com ophthalmologytimes.com/view/microdrops-of-timolol-maleate-0-5-show-no-clinically-significant-difference-in-iop-compared-to-standard-size-drops

Microdrops of timolol maleate 0.5% show no clinically ... In this study, timolol 0.5% decreased IOP by 20.22% (95% CI: 18.86 to 21.58%) at hour 1, 28.56% (95% CI: 27.20 to 29.92%) at hour 2, 29.43% (95% ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05273385?term=AREA%5BBasicSearch%5D(nanodropper)&rank=1

Efficacy of the Nanodropper Device on Intraocular ... A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved ...

6. nanodropper.com nanodropper.com/wp-content/uploads/2024/06/240617-Nanodropper-whitepaper_safety-and-efficacy-of-microdrops.pdf

Oversized eyedrops may compromise glaucoma patient ... Oversized eyedrops may compromise glaucoma patient adherence, causing disease progression and irreversible vision loss. Glaucoma is a leading ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10086215/

Reduction of Eyedrop Volume for Topical Ophthalmic ... The Nanodropper eyedrop bottle adaptor can significantly reduce drop volume and increase the overall number of drops dispensed compared with stock eyedrop ...

8. withpower.com withpower.com/trial/phase-glaucoma-1-2022-5d9d3

Nanodropper Adaptor for Glaucoma · Info for Participants The purpose of this study is to evaluate the safety, efficacy, and usability of an eyedrop bottle adaptor that creates smaller eyedrops, Nanodropper, in an open ...