What side effects are associated with this type of intervention?

Common treatments for glaucoma, particularly selective alpha-2 adrenergic receptor agonists like Brimonidine (Lumify™), can cause side effects such as dry mouth, fatigue, and ocular hyperemia (eye redness). Other potential side effects include allergic reactions, drowsiness, and a slight decrease in blood pressure. More broadly, glaucoma treatments like beta-blockers, prostaglandin analogs, and carbonic anhydrase inhibitors can cause side effects ranging from eye irritation and changes in eye color to systemic effects like respiratory issues and electrolyte imbalances.

What prior FDA approvals exist?

Lumify™ (Brimonidine Tartrate Ophthalmic Solution 0.025%) is an FDA-approved medication for alleviating eye redness, and it works through selective alpha-2 adrenergic receptor agonism. Other FDA-approved treatments for glaucoma that share a similar mechanism include higher concentrations of Brimonidine (0.1%, 0.15%, and 0.2%), which are used to lower intraocular pressure. These medications reduce aqueous humor production and increase uveoscleral outflow, thereby helping to manage intraocular pressure in glaucoma patients.

What other types of research exist?

Promising novel alternatives to Lumify™ for glaucoma patients include Rho kinase inhibitors (e.g., netarsudil), which improve aqueous humor outflow, and nitric oxide-donating prostaglandin analogs (e.g., latanoprostene bunod), which enhance both uveoscleral and trabecular outflow. These treatments offer new mechanisms of action and have shown efficacy in lowering intraocular pressure with a favorable safety profile.

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Lumify for Glaucoma Side Effects

Phase 4

Waitlist Available

Led By Ze Zhang, MD

Research Sponsored by Tulane University

Eligibility Criteria Checklist

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

Must have

Diagnosis of primary open angle glaucoma

Age > 18 years

Must not have

Inability to sit comfortably for 30 minutes

No history of lid surgery or botox

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 60 minutes after application of eye drop

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial is testing Lumify™ eye drops, which help reduce eye redness, in glaucoma patients who are already using Brimonidine eye drops. These patients often have red eyes as a side effect of their current treatment. Lumify™ works by making the blood vessels in the eyes smaller, which helps to reduce redness.

Who is the study for?

This trial is for adults over 18 with primary open-angle glaucoma who've been using Brimonidine eye drops (0.1%, 0.15%, or 0.2%) for more than six weeks and can consent to participate. It's not for pregnant individuals, prisoners, those with recent surgeries, lid surgery or botox history, allergies to brimonidine, or use of certain eye medications within the last week.

What is being tested?

The study tests Lumify™ (Brimonidine Tartrate Ophthalmic Solution 0.025%) against a saline solution in glaucoma patients already on Brimonidine treatment. The focus is on its effects on ocular redness, intraocular pressure (IOP), and eyelid position.

What are the potential side effects?

Lumify™ may cause minor eye irritation, dry mouth, drowsiness, or mild headaches as side effects based on previous knowledge about Brimonidine solutions used in similar concentrations.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with primary open angle glaucoma.

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I am older than 18 years.

Exclusion Criteria

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

Select...

I cannot sit comfortably for 30 minutes.

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I have never had eyelid surgery or Botox injections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 60 minutes after application of eye drop

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~60 minutes after application of eye drop

This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 minutes after application of eye drop 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

Ocular redness

Secondary study objectives

Eye discomfort

Palpebral fissure height

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Lumify ArmExperimental Treatment1 Intervention

In each subject, each eye will be randomized to receive a single drop of either Lumify™ (brimonidine tartrate ophthalmic solution 0.025%) or a sterile balanced saline solution.

Group II: Control ArmPlacebo Group1 Intervention

In each subject, each eye will be randomized to receive a single drop of either Lumify™ (brimonidine tartrate ophthalmic solution 0.025%) or a sterile balanced saline solution.

0 / 4Eligibility 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

Selective alpha-2 adrenergic receptor agonists, such as brimonidine (found in Lumify™), work by reducing aqueous humor production and increasing uveoscleral outflow, thereby lowering intraocular pressure (IOP). This is crucial for glaucoma patients as elevated IOP is a major risk factor for optic nerve damage, which can lead to irreversible vision loss. By effectively lowering IOP, these medications help to preserve vision and prevent the progression of glaucoma. Other common treatments for glaucoma include beta-blockers, prostaglandin analogs, and carbonic anhydrase inhibitors, which also aim to reduce IOP through various mechanisms.

The effect of selective alpha 1- and alpha 2-adrenoceptor stimulation on intraocular pressure in the conscious rabbit.