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

NCT05935527 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-01-29

No results posted yet for this 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.

Conditions

  • Lower Eyelid Steatoblepharon

Interventions

DRUG

POLAT-001

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.

DRUG

Placebo

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

Sponsors & Collaborators

  • Peregrine Ophthalmic

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-28
Primary Completion
2024-09-19
Completion
2024-11-18
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05935527 on ClinicalTrials.gov