Assess the Safety, Tolerability and Efficacy of Latanoprost Liposome for Lower Eyelid Steatoblepharon

Last updated: January 27, 2025
Sponsor: Peregrine Ophthalmic
Overall Status: Completed

Phase

1

Condition

N/A

Treatment

Placebo

POLAT-001

Clinical Study ID

NCT05935527
POLAT-001-CS-402b
  • Ages > 22
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This trial is testing a drug to see if multiple injections to the undereye bags of selected patients decreases the volume of the eyebags as compared to placebo. Subjects will be randomized to receive either one of two doses of POLAT-001 or placebo. POLAT-001 will be injected into the eyebags at three of the visits. Each subject will attend 7-10 clinic visits over 98 to 140 days total to assess efficacy and safety.

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

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1
Study Start date:
April 28, 2023
Estimated Completion Date:
November 18, 2024

Study Description

This trial is a proof-of-concept trial and is testing a drug to see if multiple injections to the undereye bags of selected patients decreases the volume of the eyebags as compared to placebo. Subjects will be randomized to receive either one of two doses of POLAT-001 (1 mg/mL or 2 mg/mL) or placebo (normal saline). POLAT-001 will be injected into the eyebags at three of the visits. Each subject will attend 7-10 clinic visits total over 98 to 140 days to assess efficacy and safety. Subjects assigned to placebo will crossover to receive active treatment. Efficacy will be determined using questionnaires and photography. Safety will be assessed by subject-reported events and investigator observations of the subjects.

Connect with a study center

  • Medical Associates, Inc.

    Newport Beach, California 92663
    United States

    Site Not Available

  • Skin Associates of South Florida

    Coral Gables, Florida 33146
    United States

    Site Not Available

  • Austin Institute for Clinical Research

    Pflugerville, Texas 78660
    United States

    Site Not Available

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