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

150 Participants Needed

Trial Summary

What is the purpose of this trial?

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-angle glaucoma/ocular hypertension patient population.

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 data supports the effectiveness of the Nanodropper Adaptor treatment for glaucoma?

Research shows that the Nanodropper Adaptor can reduce the volume of eyedrops, which may help limit eye irritation and extend the use of the medication bottle. Additionally, using a device dropper method can improve patient satisfaction and ease of use compared to traditional methods, potentially leading to better treatment outcomes. ^{1 2 3 4 5}

Is the Nanodropper Adaptor safe for use in humans?

Research on the Nanodropper Adaptor suggests it is used to reduce the volume of eye drops, which may help limit potential eye irritation or toxicity. However, specific safety data for humans is not detailed in the available studies. ^{1 2 3 6 7}

How does the Nanodropper adaptor treatment for glaucoma differ from other treatments?

The Nanodropper adaptor is unique because it reduces the volume of eyedrops dispensed, which can limit eye irritation and extend the use of the eyedrop bottle. This approach contrasts with traditional eyedroppers that often deliver more liquid than the eye can handle, potentially causing side effects. ^{1 2 3 5 8}

Research Team

Raghu Mudumbai

Principal Investigator

University of Washington

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Novel Eye Drop Delivery Aid Improves Outcomes and Satisfaction. [2021]

2. England pubmed.ncbi.nlm.nih.gov

One-year surgical outcomes of the PreserFlo MicroShunt in glaucoma: a multicentre analysis. [2023]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Reduction of Eyedrop Volume for Topical Ophthalmic Medications with the Nanodropper Bottle Adaptor. [2023]

4. England 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. [2022]

5. New Zealand 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. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Randomized Trial to Evaluate the Efficacy of the Nanodropper Device for Pupillary Dilation and Cycloplegia in Children. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Short-term safety and efficacy of Preserflo™ Microshunt in glaucoma patients: a multicentre retrospective cohort study. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Intraocular pressure-lowering effects of all commonly used glaucoma drugs: a meta-analysis of randomized clinical trials. [2022]