Nanodropper for Glaucoma

Overseen By Sreevardhan Alluri, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston Medical Center

Must be taking: Topical ophthalmic

Disqualifiers: Changed medications, others

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

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the Nanodropper, a device that controls the size of eye drops, can help glaucoma patients use their medication correctly. Glaucoma can lead to blindness if not managed well, and many patients struggle with proper eye drop application. Participants will use the Nanodropper for several weeks and then switch to their usual method, or vice versa, to assess which is more effective. Patients at Boston University Eye Associates who have used the same eye medication for at least two months might be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative solutions for improving medication use in glaucoma care.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications, but it requires that you have been on the same glaucoma eye drops for at least two months before joining.

What prior data suggests that the Nanodropper is safe for glaucoma patients?

Research has shown that the Nanodropper is safe to use. One study found that using the Nanodropper for eye drops did not cause any major side effects and was just as effective as regular eye drop methods in lowering eye pressure, which is important for treating glaucoma. Another study found that the Nanodropper reduced wasted medication, requiring fewer drops to achieve the same results. This can improve safety by lowering the risk of irritation or other problems. Overall, evidence suggests that the Nanodropper is a safe method for delivering glaucoma medication. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Nanodropper because it offers a unique approach to managing glaucoma. Unlike traditional eye drop options that can lead to waste due to oversized drops, the Nanodropper is a drop aid device that reduces the size of each drop, potentially increasing the efficiency of medication delivery and lowering costs. This innovative delivery method could improve patient compliance by making it easier and more comfortable to administer medication. Additionally, by minimizing medication waste, the Nanodropper might also reduce side effects associated with excess medication exposure.

What evidence suggests that the Nanodropper is effective for glaucoma?

Research has shown that the Nanodropper can help manage glaucoma. A study by Pasquale and colleagues in 2018 found that using smaller eye drops with the Nanodropper significantly lowered eye pressure in adults with glaucoma. Another study found that the Nanodropper lowered eye pressure as effectively as standard treatments, but with less impact on heart rate and blood pressure. Additionally, the Nanodropper reduces waste, allowing people to use less medication while maintaining the same benefits. In this trial, participants will be randomized into two groups: one group will use the Nanodropper first and then switch to no drop aid, while the other group will start with no drop aid and then switch to using the Nanodropper. These findings suggest that the Nanodropper could improve both the use and effectiveness of medication for people with glaucoma. ^{1 2 3 4 6}

Who Is on the Research Team?

Manishi Desai, MD

Principal Investigator

BostonMedical Center, Ophthalmology

Are You a Good Fit for This Trial?

This trial is for patients at the Yawkey Eye Clinic with glaucoma who struggle to use eye drops due to poor vision or difficulty handling bottles. It's not clear who can't participate since exclusion criteria are not provided.

Inclusion Criteria

Patient of Boston University Eye Associates

I've been using the same eye drops for glaucoma for at least 2 months.

Exclusion Criteria

I have not changed my glaucoma medications in the last 2 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Instruction and Baseline Assessment

Participants are instructed on how to use the Nanodropper and undergo a preintervention intraocular pressure check

1 week

1 visit (in-person)

Treatment Period 1

Participants use the Nanodropper or no drop aid device for 4-6 weeks

4-6 weeks

1 visit (in-person), 1 phone call

Treatment Period 2

Participants switch to the opposite condition (use the Nanodropper or no drop aid device) for another 4-6 weeks

4-6 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Nanodropper

Trial Overview The study tests the Nanodropper, a device designed to help glaucoma patients apply their medication more easily and accurately, potentially improving treatment adherence and preserving vision.

How Is the Trial Designed?

Group I: No drop aid then drop aid Experimental Treatment 1 Intervention

Participants randomized into this group will be assigned to use no drop aid over the first 4-6 weeks, and then to use the Nanodropper over the next 4-6 weeks.

Group II: Drop aid used then no drop aid Experimental Treatment 1 Intervention

Participants randomized into this group will be assigned to use the Nanodropper over the first 4-6 weeks, and then no drop aid device over the next 4-6 weeks.

Who Is Running the Clinical Trial?

Boston Medical Center

Lead Sponsor

Trials

410

Recruited

890,000+

Boston Medical Center Patient Safety Grant

Collaborator

Trials

1

Recruited

80+

Published Research Related to This Trial

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]

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]

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]

Recent advancements in glaucoma treatment include new topical medications that target the trabecular meshwork and conventional outflow pathways, such as rho kinase inhibitors and nitric oxide donating compounds, which have received FDA approval and aim to reduce intraocular pressure more effectively.

Innovative therapies like gene therapy and stem cell strategies are being developed to provide long-term pressure control without the need for daily eye drops, potentially easing the treatment burden for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glaucoma Drugs in the Pipeline. Kaufman, PL., Mohr, ME., Riccomini, SP., et al.[2018]

The safety profile of glaucoma medications is crucial for treatment adherence, as side effects can lead to patients not following their prescribed therapy.

Long-term use of glaucoma eyedrops, especially those with preservatives, can cause ocular surface changes and systemic effects, highlighting the need for careful selection of medications and patient education on potential side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Side effects of glaucoma medications. Detry-Morel, M.[2018]

Omidenepag isopropyl (OMDI) significantly reduced intraocular pressure (IOP) in untreated open-angle glaucoma patients, dropping from a baseline of 15.7 mmHg to 13.7 mmHg after 3 months, indicating its efficacy as a first-line treatment.

Switching from prostaglandin F receptor agonists to OMDI in patients already on treatment did not result in significant changes in IOP, suggesting that while OMDI is effective as a new treatment, it may not provide additional benefits when replacing existing therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Newly or switching effect of a selective EP2 agonist on intraocular pressure in Japanese patients with open-angle glaucoma. Ueda, K., Sakata, R., Fujishiro, T., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10108985/

Randomized Trial to Evaluate the Efficacy of the Nanodropper ... Pasquale et al in 2018 showed significant intraocular pressure reduction for adults with glaucoma who used small-volume drops of latanoprost.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05273385

Efficacy of the Nanodropper Device on Intraocular ... The proposed study hopes to demonstrate the non-inferiority of using Nanodropper to lower intraoccular pressure (IOP) in glaucoma patients compared to standard ...

3. 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 ... Overall, the use of the Nanodropper Adaptor provided comparable IOP-lowering efficacy “with a slightly lesser effect on resting cardiovascular ...

4. nanodropper.com nanodropper.com/timolol-microdrops-for-glaucoma-treatment/

Timolol Microdrops Reduce Waste and Improve Patient ... A new study shows Timolol microdrops are as effective as traditional eye drops for glaucoma offering less waste, improved safety, and better ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0161642024001891

An Evaluation of the Efficacy and Safety of Timolol Maleate ... Timolol microdrops appear to be as effective in ocular hypotensive action as conventional drops with a slightly attenuated effect on resting HR and BP.

6. nanodropper.com nanodropper.com/wp-content/uploads/2024/09/Nanodropper-Clinical-Data-Summary.pdf

Nanodropper-Clinical-Data-Summary.pdf Twelve-Week Randomized, Controlled, Non-Inferiority Trial Evaluating the Safety and ... In stable glaucoma patients, microdrops decreased IOP from baseline ...