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POLAT-001 for Lower Eyelid Entropion
Phase 1
Recruiting
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 baseline to 28 days after the last treatment cycle
Awards & highlights
Study Summary
This trial tests a drug to reduce the volume of undereye bags. Subjects receive injections over 98-140 days and 7-10 visits will assess safety & efficacy.
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.Check my eligibility
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.See study design
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 ~ baseline to 28 days after the last treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 28 days after the last treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean change of photonumeric volume of eyebags in the POLAT-001 treated and placebo dose groups as measured by a 3D photography system
Secondary outcome measures
Mean change in photonumeric volume of eyebags between the POLAT-001 treated high and low dose groups as measured by a 3D photography system
Proportion of eyebags in the POLAT-001 treated and placebo dose groups with at least 10% reduction in photonumeric volume as measured by a 3D photography system
Proportion of eyebags in the POLAT-001 treated and placebo dose groups with at least 30% reduction in photonumeric volume as measured by a 3D photography system
Side effects data
From 2016 Phase 2 trial • 80 Patients • NCT024663994%
Nasopharyngitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Latanoprost Ophthalmic Solution
POLAT-001
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
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
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has POLAT-001 been given the green light by the FDA?
"Since this is an early-stage trial, the safety and efficacy of POLAT-001 has been tentatively assessed as a 1 on our scale. Limited data exists to support its potential benefits."
Answered by AI
Are enrollees currently being accepted into this experiment?
"Affirmative. According to information hosted on clinicaltrials.gov, this medical study is actively looking for participants which was initially published on April 28th 2023 and most recently updated on June 29th 2023. A total of 40 patients are required across 1 facility."
Answered by AI
How many volunteers are participating in this research experiment?
"Affirmative. Clinicaltrials.gov displays that this clinical trial, which was originally posted on April 28th 2023, is presently searching for participants. Approximately 40 patients are needed to be recruited from 1 medical facility."
Answered by AI
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