search
Back to results

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

Primary Purpose

Lower Eyelid Steatoblepharon

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
POLAT-001
Placebo
Sponsored by
Peregrine Ophthalmic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lower Eyelid Steatoblepharon focused on measuring Steatoblepharon, Eyebag, Under eyelid

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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). Any laboratory findings that based on clinical assessment of the investigator would place 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, or not 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 may place the subject at risk or confound study results.

Sites / Locations

  • Medical Associates, Inc.Recruiting
  • Skin Associates of South FloridaRecruiting
  • Austin Institute for Clinical ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo (Normal Saline)

POLAT-001

Arm Description

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.

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

Outcomes

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

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

Full Information

First Posted
June 29, 2023
Last Updated
August 24, 2023
Sponsor
Peregrine Ophthalmic
search

1. Study Identification

Unique Protocol Identification Number
NCT05935527
Brief Title
Assess the Safety, Tolerability and Efficacy of Latanoprost Liposome for Lower Eyelid Steatoblepharon
Official Title
Assess the Safety, Tolerability and Efficacy of Latanoprost Liposome for Lower Eyelid Steatoblepharon
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 28, 2023 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peregrine Ophthalmic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Eyelid Steatoblepharon
Keywords
Steatoblepharon, Eyebag, Under eyelid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo (Normal Saline)
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
POLAT-001
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
POLAT-001
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Normal Saline
Intervention Description
Subjects will be randomized to receive three injections of 120 microliters total of Normal Saline per under eyebag at each of three treatment visits.
Primary Outcome Measure Information:
Title
Mean change of photonumeric volume of eyebags in the POLAT-001 treated and placebo dose groups as measured by a 3D photography system
Time Frame
Baseline to 28 days after the last treatment cycle
Secondary Outcome Measure Information:
Title
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
Time Frame
Baseline to 28 days after the last treatment
Title
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
Time Frame
Baseline to 28 days after the last treatment cycle
Title
Mean change in photonumeric volume of eyebags between the POLAT-001 treated high and low dose groups as measured by a 3D photography system
Time Frame
Baseline to 28 days after the last treatment cycle

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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). Any laboratory findings that based on clinical assessment of the investigator would place 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, or not 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 may place the subject at risk or confound study results.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Solomon Su, PhD
Phone
978-2046003
Email
ssu@peregrinop.com
First Name & Middle Initial & Last Name or Official Title & Degree
Deborah Jezior
Email
deb@dajezior.com
Facility Information:
Facility Name
Medical Associates, Inc.
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
949-548-2711
Facility Name
Skin Associates of South Florida
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alex Cazzaniga
Phone
305-443-6606
Facility Name
Austin Institute for Clinical Research
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
512-279-2545

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs