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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
Awards & highlights

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 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
6%
Nasopharyngitis
6%
Instillation site erythema
2%
bone and bladder cancer
100%
80%
60%
40%
20%
0%
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

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.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Peregrine OphthalmicLead Sponsor
2 Previous Clinical Trials
98 Total Patients Enrolled

Media Library

Placebo (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05935527 — Phase 1
Lower Eyelid Entropion Research Study Groups: POLAT-001, Placebo (Normal Saline)
Lower Eyelid Entropion Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05935527 — Phase 1
Placebo (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05935527 — Phase 1
~17 spots leftby Oct 2025