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

80 Participants Needed

Trial Summary

What is the purpose of this trial?

Glaucoma medications are vital to disease management and prevention of further loss of vision as over time glaucoma will lead to irreversible blindness. The average size of a glaucoma medication bottle is around 10cc and these medications when used 2-3 times daily are expected to last patients an entire month. The investigators found that at Boston Medical Center (BMC) a majority of Yawkey Eye Clinic patients are unable to deliver the drops into their eyes due to poor vision or difficulty squeezing drop bottles. These patients also often deliver more than a necessary amount leading to premature completion of the bottle. However, because the cost benefit ratio of these drop aids is unclear, they are not routinely offered to the patients. Although the efficacy of these drop aids has not been well studied, if effective, the cost of these drop aids would more than pay themselves by improving medication compliance and visual function of the patients. This study aims to determine the efficacy of the Nanodropper in the BMC Yawkey Eye Clinic patient population.

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 data supports the effectiveness of the Nanodropper treatment for glaucoma?

The research shows that using a device dropper method, like the Nanodropper, can improve ease of use, patient satisfaction, and control of eye pressure in glaucoma patients compared to traditional eye drop methods. Additionally, novel delivery systems for glaucoma medications, such as nanoliposome formulations, have shown significant reductions in eye pressure, suggesting that innovative delivery methods can enhance treatment outcomes. ^{1 2 3 4 5}

Is the Nanodropper safe for use in humans?

Research suggests that using precise microdoses of glaucoma medications, like those potentially delivered by the Nanodropper, can reduce exposure to drugs and preservatives, which may lower the risk of side effects compared to traditional eyedropper methods. This approach aims to minimize common side effects such as eye irritation and systemic effects from excess medication. ^{5 6 7 8 9}

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

The Nanodropper treatment is unique because it uses a bottle adaptor to reduce the volume of each eyedrop, which can help limit eye irritation and make the medication last longer compared to traditional eyedrop bottles. ^{1 5 10 11 12}

Research Team

Manishi Desai, MD

Principal Investigator

BostonMedical Center, Ophthalmology

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. 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]

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

Nanomedicine for glaucoma: sustained release latanoprost offers a new therapeutic option with substantial benefits over eyedrops. [2022]

3. China pubmed.ncbi.nlm.nih.gov

Glaucoma Drugs in the Pipeline. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Medical anti-glaucoma therapy: Beyond the drop. [2021]

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

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

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

Managing adverse effects of glaucoma medications. [2021]

7. 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]

8. Belgium pubmed.ncbi.nlm.nih.gov

Side effects of glaucoma medications. [2018]

9. Japan pubmed.ncbi.nlm.nih.gov

Newly or switching effect of a selective EP2 agonist on intraocular pressure in Japanese patients with open-angle glaucoma. [2022]

10. England pubmed.ncbi.nlm.nih.gov

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

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

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

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

Clinical results with the Trabectome for treatment of open-angle glaucoma. [2022]