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

NCT05935527 | Completed Phase 1 FDA Drug

• 1 other identifier: POLAT-001-CS-402b
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Lower Eyelid Steatoblepharon

Keywords

Steatoblepharon; Eyebag; Under eyelid

Outcome Measures

Primary Outcomes (1)

• Mean change of photonumeric volume of eyebags in the POLAT-001 treated and placebo dose groups as measured by a 3D photography system

  Baseline to 28 days after the last treatment cycle

Secondary Outcomes (3)

• 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

  Baseline to 28 days after the last treatment

• 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

  Baseline to 28 days after the last treatment cycle

• Mean change in photonumeric volume of eyebags between the POLAT-001 treated high and low dose groups as measured by a 3D photography system

  Baseline to 28 days after the last treatment cycle

Study Arms (2)

Placebo (Normal Saline)

PLACEBO COMPARATOR

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.

Drug: Placebo

POLAT-001

EXPERIMENTAL

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

Drug: POLAT-001

Interventions

POLAT-001 DRUG

Subjects will be randomized to receive three injections per under eyebag, either 1 mg/mL or 2 mg/mL and 120 microliter volume, at each of three treatment visits.

POLAT-001

Placebo DRUG

Subjects will be randomized to receive three injections of 120 microliters total of Normal Saline per under eyebag at each of three treatment visits.

Also known as: Normal Saline

Placebo (Normal Saline)

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult subjects, 22 years or older with moderate to severe convexity or fullness associated with periorbital fat.
• Subject has moderate to severe eyebags per Goldberg and Simon's Orbital Fat Grading System, per protocol requirements.
• Willing and able to attend all study visits.

You may not qualify if:

• Any signs or symptoms of periorbital disease in the study eye and related complications, as determined by the investigator.
• Active thyroid eye disease, chronic ocular inflammatory orbital disease or other ophthalmic disease that could confound study results.
• Evidence of infection, or clinically significant periocular, periorbital or conjunctival inflammation or conditions that in the opinion of the investigator would constitute a risk or could confound the study results.
• History of hypersensitivity to prostaglandin analogs or prostaglandin PF2alpha treatments.
• 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 study eye.
• Surgical or laser treatment of the eye or surrounding anatomical structures within 6 months 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 months prior to Screening.
• The subject has received botulinum toxin treatment of the inferior pretarsal orbicularis 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 during the study in the study eye (e.g., retinal detachment, significant cataract, uncontrolled glaucoma).
• Facial nerve injury or abnormal weakness, other facial rejuvenation injections (not including botulinum toxin) in the treated area, facial surgery, or facial trauma within 3 months prior to Screening. History or concurrent systemic condition that would preclude the safe administration of the study treatment or confound the results of the safety (e.g., renal or hepatic impairment).

Sponsors & Collaborators

• Peregrine Ophthalmic: lead

Study Sites (3)

Medical Associates, Inc.

Newport Beach, California, 92663, United States

Location

Skin Associates of South Florida

Coral Gables, Florida, 33146, United States

Location

Austin Institute for Clinical Research

Pflugerville, Texas, 78660, United States

Location

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participant, PI, sponsor will be masked until visit 5 at which time unmasking will occur to whether placebo or treatment so that placebo subjects can cross over to receive active treatment.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2023
• First Posted: July 7, 2023
• Study Start: April 28, 2023
• Primary Completion: September 19, 2024
• Study Completion: November 18, 2024
• Last Updated: January 29, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)