What side effects are associated with this type of intervention?

Common treatments for Lower Eyelid Entropion that involve localized injections, such as those being studied in the POLAT-001 trial, include the use of botulinum toxin and filler injections. Known side effects of these treatments can include localized pain, swelling, bruising, and redness at the injection site. In rare cases, there may be temporary muscle weakness or asymmetry in facial expressions. It is important for patients to discuss these potential side effects with their healthcare provider to make an informed decision.

What prior FDA approvals exist?

The provided context does not mention any specific FDA approvals for the treatment of lower eyelid entropion. However, it does discuss various injectable treatments for other conditions, such as soft tissue fillers and BoNT injections for drooling. These treatments involve localized injections similar to the approach being studied in the POLAT-001 trial for reducing undereye bag volume. For entropion, surgical correction is typically the standard treatment, but no specific injectable treatments for entropion are detailed in the provided information.

What other types of research exist?

Promising alternatives to POLAT-001 for lower eyelid entropion include injectable soft tissue fillers such as hyaluronic acid and calcium hydroxylapatite, which have been used effectively for facial soft-tissue augmentation. These fillers can provide structural support and improve the appearance of the lower eyelid. Additionally, poly-L-lactic acid implants and other long-lasting injectable materials like ArteFill have shown efficacy in similar applications and could be considered as novel options for 2024.

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Other

Latanoprost Liposome for Undereye Bags

Phase 1

Waitlist Available

Research Sponsored by Peregrine Ophthalmic

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial is testing POLAT-001 injections to see if they can reduce the size of undereye bags in patients. The drug is injected directly into the undereye area, and patients will attend regular clinic visits to check if the treatment works and is safe.

Who is the study for?

Adults over 22 with moderate to severe undereye bags, who can attend multiple clinic visits. Excluded are those using certain eye treatments or steroids, pregnant or nursing women not on birth control, anyone with hypersensitivity to prostaglandin treatments, recent facial procedures or injections, and conditions that could risk safety or skew results.

What is being tested?

The trial is testing POLAT-001's effectiveness in reducing undereye bag volume compared to a placebo. Participants will be randomly assigned to receive either POLAT-001 at two different doses or a placebo through injections during several clinic visits over approximately 3-5 months.

What are the potential side effects?

While the specific side effects of POLAT-001 aren't listed here, similar treatments may cause injection site reactions, swelling, redness, discomfort around the eyes and potential allergic reactions for those sensitive to ingredients.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2016 Phase 2 trial • 80 Patients • NCT02466399

26%

Conjunctival haemorrhage

17%

Foreign body sensation in eyes

13%

Conjunctival hyperaemia

Instillation site erythema

Nasopharyngitis

bone and bladder cancer

100%

80%

60%

40%

20%

Study treatment Arm

POLAT-001

Latanoprost Ophthalmic Solution

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: POLAT-001Experimental Treatment1 Intervention

Subjects will be randomized 1:5 (1 Placebo subject to 5 receiving active treatment) to receive POLAT-001 with a volume of 120 microliters injection, at either 1 mg/mL or 2 mg/mL

Group II: Placebo (Normal Saline)Placebo Group1 Intervention

Subjects will be randomized 1:5 (1 Placebo subject to 5 receiving active treatment) to receive placebo (Normal Saline) with a volume of 120 microliters injection.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

POLAT-001

2015

Completed Phase 2

~80

Do I qualify?Apply below to find out

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 Lower Eyelid Entropion include surgical procedures and localized injections. Surgical methods often involve tightening or repositioning the eyelid to correct its inward turning, which can alleviate irritation and prevent damage to the cornea. Localized injections, such as those studied in the POLAT-001 trial, aim to reduce the volume of undereye bags by injecting substances that either dissolve fat or stimulate collagen production, thereby improving the structural support of the eyelid. These treatments are crucial for patients as they directly address the anatomical issues causing entropion, providing relief from symptoms and preventing further ocular complications.

Six-month effects of a thermodynamic treatment for MGD and implications of meibomian gland atrophy.Evaluation of a novel eyelid-warming device in meibomian gland dysfunction unresponsive to traditional warm compress treatment: an in vivo confocal study.