Phase
Condition
N/ATreatment
Placebo
POLAT-001
Clinical Study ID
Ages > 22 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Adult subjects, 22 years or older with moderate to severe convexity or fullnessassociated with periorbital fat.
Subject has moderate to severe eyebags per Goldberg and Simon's Orbital Fat GradingSystem, per protocol requirements.
Willing and able to attend all study visits.
Exclusion
Exclusion Criteria:
Any signs or symptoms of periorbital disease in the study eye and relatedcomplications, as determined by the investigator.
Active thyroid eye disease, chronic ocular inflammatory orbital disease or otherophthalmic disease that could confound study results.
Evidence of infection, or clinically significant periocular, periorbital orconjunctival inflammation or conditions that in the opinion of the investigatorwould constitute a risk or could confound the study results.
History of hypersensitivity to prostaglandin analogs or prostaglandin PF2alphatreatments.
Known hypersensitivity to any component of the investigational product formulation.
Use of periocular corticosteroids within 2 months prior to Screening.
Use of intravitreal (IVT) injections within 3 weeks prior to Screening in the studyeye.
Surgical or laser treatment of the eye or surrounding anatomical structures within 6months prior to Screening in the study eye.
Previous history of lower incisional eyelid surgery.
Previous history of undereye lid tattoo or underage lash extensions.
Previous history of infra-orbital or anterior medical cheek fillers within 24 monthsprior to Screening.
The subject has received botulinum toxin treatment of the inferior pretarsalorbicularis oculi muscle within 6 months of the first injection.
History of ocular trauma in the study eye within 6 months prior to Screening.
Any concurrent disease that would require medical or surgical intervention duringthe study in the study eye (e.g., retinal detachment, significant cataract,uncontrolled glaucoma).
Facial nerve injury or abnormal weakness, other facial rejuvenation injections (notincluding botulinum toxin) in the treated area, facial surgery, or facial traumawithin 3 months prior to Screening. History or concurrent systemic condition thatwould preclude the safe administration of the study treatment or confound theresults of the safety (e.g., renal or hepatic impairment).
Any laboratory findings that based on clinical assessment of the investigator wouldplace the subject at risk or could confound th study results.
Significant infraorbital vascular prominence.
Women of childbearing potential who are pregnant, nursing, planning a pregnancy, ornot using a medically acceptable form of birth control.
Participation in an interventional clinical study within 30 days prior to Screening.
Any other criterion that based on the clinical judgement of the investigator mayplace the subject at risk or confound study results.
Study Design
Study Description
Connect with a study center
Medical Associates, Inc.
Newport Beach, California 92663
United StatesSite Not Available
Skin Associates of South Florida
Coral Gables, Florida 33146
United StatesSite Not Available
Austin Institute for Clinical Research
Pflugerville, Texas 78660
United StatesSite Not Available
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