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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2016 Phase 2 trial • 80 Patients • NCT0246639926%
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.
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.
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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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had eye surgery or laser treatment in the last 6 months.I have an eye condition that could affect the study's results.I have signs of eye disease as confirmed by my doctor.I do not have any health conditions that would make the study treatment unsafe for me.I do not have any eye conditions needing treatment during the study.I haven't had facial injuries, surgeries, or certain injections in the last 3 months.I have noticeable swelling under my eyes.I can attend all required study visits.I am 22 or older with moderate to severe under-eye puffiness.I do not have eye infections or inflammation that could risk or affect the study.I have not had cheek or under-eye fillers in the last 2 years.I have moderate to severe under-eye bags.I have had surgery on my lower eyelid before.I am not pregnant, nursing, planning to become pregnant, and I use effective birth control.I have had an eye injury in the past 6 months.I haven't used eye steroids in the last 2 months.I haven't had eye injections in the last 3 weeks.I've had botulinum toxin treatment near my eyelid within the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: POLAT-001
- Group 2: Placebo (Normal Saline)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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