What side effects are associated with this type of intervention?

Common treatments for glaucoma, particularly those involving eye drops to lower intraocular pressure, include prostaglandin analogues, beta-blockers, alpha agonists, and carbonic anhydrase inhibitors. Side effects of these treatments can include eye redness, stinging, blurred vision, changes in eye color, eyelash growth, and systemic effects such as low blood pressure and fatigue. The Nanodropper device, which administers smaller, precise doses of medication, aims to reduce these side effects by minimizing the amount of excess medication that can cause irritation and systemic absorption.

What prior FDA approvals exist?

The FDA has approved various treatments for glaucoma that aim to lower intraocular pressure (IOP). Traditional treatments include prostaglandin analogues, beta-blockers, alpha agonists, and carbonic anhydrase inhibitors, which are typically administered as eye drops. Recent advancements have focused on improving drug delivery methods to enhance efficacy and patient adherence. For instance, sustained-release prostaglandin analogues and nanotechnological-release delivery systems have shown promise in effectively lowering IOP while addressing adherence issues associated with daily eye drop use. The Nanodropper device, which administers smaller, precise doses of medication, aligns with these advancements by potentially reducing waste and improving the consistency of drug delivery.

What other types of research exist?

Promising novel alternatives to the Nanodropper for glaucoma patients include: 1) Hyaluronic acid-chitosan-latanoprost nanoparticle (HA-CS-latanoprost NP) eye drops, which have shown efficacy in reducing IOP in studies. 2) The use of smaller, precise doses of traditional medications like latanoprost, as demonstrated in studies comparing different drop sizes. These alternatives focus on improving drug delivery and efficacy while minimizing side effects.

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Nanodropper Device for Glaucoma

N/A

Recruiting

Led By Julius Oatts, MD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Use of prostaglandin analogue (PGA) eye drop

18 years old or older

Must not have

Uncontrolled glaucoma

Use of non-PGA class of IOP-lowering medication

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if a device called the Nanodropper, which gives smaller eye drops, works as well as regular eye drops for adults with stable glaucoma or high eye pressure. The goal is to see if using less liquid can still effectively lower eye pressure.

Who is the study for?

This trial is for adults with stable open-angle glaucoma or ocular hypertension who've been using prostaglandin analogue eye drops. It's not suitable for those who've had recent eye surgery, have uncontrolled glaucoma, acute angle-closure glaucoma, other retinal diseases, or use non-PGA IOP-lowering meds.

What is being tested?

The study tests the Nanodropper device to see if it's as good as standard eye drops at lowering intraocular pressure in patients with glaucoma. The goal is to prove that smaller drops from this device work just as well without compromising treatment efficacy.

What are the potential side effects?

While specific side effects of the Nanodropper aren't detailed here, typical eye drop-related side effects can include temporary discomfort, redness in the eyes, blurred vision, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am using prostaglandin eye drops.

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I am 18 years old or older.

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I have been diagnosed with open-angle glaucoma or high eye pressure.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My glaucoma is not under control.

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I am using eye pressure medication that is not in the PGA class.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Intraocular pressure (IOP) at Baseline

Intraocular pressure (IOP) at Month 1

Intraocular pressure (IOP) at Month 3

Secondary study objectives

Conjunctival Grading at Baseline

Conjunctival Grading at Month 3

Survey

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: NanodropperExperimental Treatment1 Intervention

Participants will receive the Nanodropper with instructions and attend clinic visits at baseline, 1, and 3 months. Participants will administer their eye drops using the Nanodropper.

Group II: Standard of Care DropperActive Control1 Intervention

Participants will receive standard of care eye dropper with instructions and attend clinic visits at baseline, 1, and 3 months. Participants will administer their eye drops using the standard of care eye dropper.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nanodropper

2021

N/A

~110

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for glaucoma primarily aim to lower intraocular pressure (IOP) to prevent optic nerve damage. Prostaglandin analogs increase the outflow of aqueous humor, while beta-blockers reduce aqueous humor production. Alpha agonists both decrease production and increase outflow. Carbonic anhydrase inhibitors reduce fluid production, and Rho kinase inhibitors enhance outflow through the trabecular meshwork. The Nanodropper device, which administers smaller, precise doses of these medications, is significant because it maintains efficacy while potentially reducing side effects and medication waste, thereby improving patient adherence and outcomes.