What side effects are associated with this type of intervention?

Common treatments for entropion include surgical procedures, botulinum toxin injections, and lubricating eye drops. Surgical correction can lead to complications such as infection, bleeding, and scarring. Botulinum toxin injections may cause temporary ptosis, double vision, or dry eyes. Lubricating eye drops generally have minimal side effects but can sometimes cause mild irritation or allergic reactions. While brimonidine is primarily used for vasoconstriction and reducing intraocular pressure in glaucoma, its side effects can include dry mouth, fatigue, and ocular hyperemia.

What prior FDA approvals exist?

There are no FDA-approved treatments for entropion that focus on vasoconstriction and reduction of intraocular pressure similar to brimonidine. Entropion is typically treated through surgical procedures or temporary measures such as botulinum toxin injections to alleviate the inward turning of the eyelid. Brimonidine is primarily used for conditions like glaucoma and ocular hypertension due to its intraocular pressure-lowering effects.

What other types of research exist?

Promising alternatives to Brimonidine for entropion patients in 2024 may include newer vasoconstrictors or intraocular pressure-lowering agents such as Rho kinase inhibitors (e.g., netarsudil) and prostaglandin analogs (e.g., latanoprost). These agents have shown efficacy in reducing intraocular pressure and may offer benefits in managing symptoms associated with entropion.

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Brimonidine for Oculofacial Surgery

Phase 4

Recruiting

Led By Christopher Compton, MD

Research Sponsored by University of Louisville

Eligibility Criteria Checklist

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

Must have

Ophthalmic conditions requiring oculoplastic surgery

Above the age of 18

Must not have

History of Central Nervous System (CNS) depression from medication use

Hypotony

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at the time of surgery.

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial tests if brimonidine eye drops can help control bleeding in patients having eye-related plastic surgery by making blood vessels smaller. Brimonidine has been studied for its effectiveness in reducing bleeding and improving visibility during various eye surgeries, including trabeculectomy, LASIK, and strabismus surgery.

Who is the study for?

This trial is for adults over 18 needing oculoplastic surgery due to conditions like droopy eyelids. It's not suitable for those with eye infections, a history of CNS depression from meds, clotting issues, current brimonidine use, certain asymmetrical eye conditions, very low eye pressure (hypotony), known brimonidine allergy or side effects, a history of low blood pressure (hypotension), orthostatic hypotension, or if pregnant.

What is being tested?

The study is testing the effectiveness of a topical medication called Brimonidine in controlling bleeding during facial surgeries involving the eyes. The goal is to see how well it works when applied directly to the surgical area.

What are the potential side effects?

Brimonidine may cause dry mouth and eyes, fatigue, headache, dizziness; rarely can lead to lowered heart rate or blood pressure. Side effects are generally mild but vary between individuals.

Eligibility Criteria

Inclusion Criteria

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

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I need eye surgery due to a condition.

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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:

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I have experienced brain fog or drowsiness from medication.

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I have low eye pressure.

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I experience significant drops in blood pressure when standing up.

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I have a history of low blood pressure.

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I currently have an eye infection.

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I have a blood clotting disorder.

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I am currently using brimonidine.

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I have an eye condition affecting tear drainage.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at the time of surgery.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at the time of surgery.

This trial's timeline: 3 weeks for screening, Varies for treatment, and at the time of surgery. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Hemostatic function

Side effects data

From 2013 Phase 4 trial • 376 Patients • NCT02003534

Conjunctiva Hyperemia

100%

80%

60%

40%

20%

Study treatment Arm

0.15% Brimonidine Tartrate

Awards & Highlights

Drug Has Already Been Approved

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

No Placebo-Only Group

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

Pivotal Trial

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Brimonidine interventionExperimental Treatment1 Intervention

We will compare hemostasis between 2 surgical sides of the same patient. One side will be randomized to receive Brimonidine (0.15% or 0.2%) in addition to standard hemostasis measures, while the other side will receive only standard hemostasis measures (preoperative discontinuation of blood thinners, preoperative injection of lidocaine with epinephrine).

Group II: Control ArmActive Control1 Intervention

0 / 10Eligibility 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

Entropion, a condition where the eyelid turns inward, can be treated through various methods including lubricating eye drops, botulinum toxin injections, and surgical procedures. Lubricating eye drops help to protect the cornea and reduce irritation. Botulinum toxin injections temporarily paralyze the muscles causing the inward turning of the eyelid, providing relief from symptoms. Surgical procedures aim to tighten or reposition the eyelid to correct its alignment. While Brimonidine is primarily used for its vasoconstrictive properties and to reduce intraocular pressure in glaucoma, its mechanism of reducing blood flow and aqueous production is not directly applicable to Entropion treatment. However, understanding these mechanisms is crucial as they highlight the importance of targeted therapies in managing specific ocular conditions effectively.

Ocular perfusion pressure and visual field indice modifications induced by alpha-agonist compound (clonidine 0.125%, apraclonidine 1.0% and brimonidine 0.2%) topical administration. An acute study on primary open-angle glaucoma patients.Effects of a topical alpha2 adrenergic agonist on ciliary blood flow and aqueous production in rabbits.