What side effects are associated with this type of intervention?

Common treatments for ocular hypertension include medications such as latanoprost and timolol, which are often administered as eye drops. Known side effects of these treatments can include ocular irritation, redness, and dryness. Latanoprost may cause changes in eye color and eyelash growth, while timolol can lead to systemic effects such as bradycardia and respiratory issues. The use of microdrops, as studied in the Nanodropper trial, aims to reduce these side effects by minimizing drug waste and potentially improving drug delivery efficiency.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of ocular hypertension, including prostaglandin analogs like latanoprost, beta-blockers such as timolol, and carbonic anhydrase inhibitors like dorzolamide. These medications are typically administered as eye drops. The Nanodropper-mediated microdrops trial is exploring the use of reduced drop sizes to enhance drug delivery efficiency and minimize waste, which aligns with the goals of improving patient compliance and reducing side effects. While specific FDA approvals for microdrop formulations are not detailed, the concept is an extension of optimizing existing approved treatments.

What other types of research exist?

Promising alternatives to Nanodropper-mediated microdrops for Ocular Hypertension patients include: 1) Nanotechnology-based delivery systems such as hybrid dendrimer hydrogel/poly(lactic-co-glycolic acid) nanoparticles, which enhance drug delivery and patient compliance. 2) Minimally invasive glaucoma surgeries (MIGS) that offer effective intraocular pressure control with fewer complications. 3) Advanced pharmacological agents like rho kinase inhibitors and novel prostaglandin analogs that provide better efficacy and safety profiles.

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Device

Nanodropper for Glaucoma

N/A

Recruiting

Led By Alexandra Papp, MD

Research Sponsored by 59th Medical Wing

Eligibility Criteria Checklist

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

Must have

Stable disease without progression in IOP, optic disc cupping, RNFL changes, and visual field changes within the previous 1 year

On a maximum of 2 IOP lowering medications

Must not have

Glaucoma not of the POAG or OHTN variety or other retinal diseases

Progression of disease within the preceding 1 year (IOP elevation, optic disc cupping, visual field changes)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to month 6

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new method of delivering smaller eye drops using a device called Nanodropper in patients with glaucoma and high eye pressure. The goal is to see if these smaller drops work as well as regular drops in lowering eye pressure, with potentially fewer side effects and better usability. Nano eye-drops are a new type of ophthalmic treatment with increased potency and reduced side effects.

Who is the study for?

This trial is for adults over 18 with primary open-angle glaucoma or ocular hypertension who are on up to two medications to lower eye pressure and have had stable disease for the past year. It's not for those whose condition worsened in the last year, on more than two meds, or who've had certain eye surgeries.

What is being tested?

The study tests if a Nanodropper, which gives smaller drops of medication, is as safe and effective as regular eyedroppers in delivering treatment for high eye pressure. Participants will try both methods at different times to compare results.

What are the potential side effects?

Since patients use their usual medication but with a different dropper (Nanodropper), side effects should be similar to their current experience. However, there may be new discomforts related to using a new device.

Eligibility Criteria

Inclusion Criteria

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

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My eye condition has not worsened in the past year.

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I am using up to 2 medications to lower my eye pressure.

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I am over 18 and have 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 eye condition is not primary open-angle glaucoma or related to high eye pressure.

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My eye condition has worsened in the last year.

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I am using more than 2 medications to lower my eye pressure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to month 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to month 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to month 6 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change from baseline in mean intraocular pressure at 6 month

Secondary study objectives

Change from baseline in mean high contrast visual acuity at 6-month

Change from baseline in mean retinal nerve fiber layer thickness at 6-month

Change from baseline in visual field mean deviation at 6-month

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: NanodroperExperimental Treatment1 Intervention

* Patients are given a Nanodropper to use with their IOP-lowering eyedrops. * Patient returns for a safety check 1 month following the start of Nanodropper use. * At 3 months, the patient returns for clinical assessment and starts using IOP-lowering eyedrops without Nanodropper for 3 months. * The patient returns at 6 months for final clinical assessment

Group II: Regular DropperActive Control1 Intervention

* Patient continues using current IOP-lowering eyedrops without Nanodropper adaptor. * At 3 months, the patient returns for clinical assessment and starts using IOP-lowering eyedrops with Nanodropper for 3 months. * Patient returns for a safety check 1 month following the start of Nanodropper use. * The patient returns at 6 months for final clinical assessment

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

The most common treatments for Ocular Hypertension (OHT) work by lowering intraocular pressure (IOP) through various mechanisms. Prostaglandin analogs increase the outflow of aqueous humor via the uveoscleral pathway, while beta-blockers reduce aqueous humor production. Alpha agonists both decrease aqueous humor production and increase uveoscleral outflow. Carbonic anhydrase inhibitors reduce the production of aqueous humor by inhibiting the enzyme carbonic anhydrase in the ciliary body. Rho kinase inhibitors enhance trabecular meshwork outflow. These mechanisms are crucial for OHT patients as they help prevent the progression to glaucoma, which can lead to vision loss. The use of Nanodropper-mediated microdrops, which reduce drop size, may improve drug delivery efficiency and reduce waste, potentially enhancing treatment adherence and outcomes.

Increased Intraocular Pressure in Glaucomatous, Ocular Hypertensive, and Normotensive Space Shuttle Crew.Aqueous outflow imaging techniques and what they tell us about intraocular pressure regulation.Current Medical Therapy and Future Trends in the Management of Glaucoma Treatment.