Efficacy, Safety and Tolerability of liposomal latanoprost (LIPOLAT®) injection for treatment of Lower Eyelid Steatoblepharo

Phase 2

• Conditions: Eye BagLower Eyelid Steatoblepharon; Liposomal Latanoprost; prostaglandin analog; steatoblepharon, periorbital aging; injectable

• Registration Number: TCTR20200710004
• Lead Sponsor: Peregrine Opthalmic Pte Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-10
• Study Completion: 2021-03-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1) Subject has mild to moderate eyebags (as defined by certain grading confirmed by oculoplastic/plastic surgeon specialist. Grade 1-3.
2) Subject willing to comply with study requirements.
3) Subject who has signed an approved informed consent form.

Exclusion Criteria

1) Patient with asthma.
2) Patient who is pregnant or nursing or unable to use non-hormonal birth control.
3) Patient who is unwilling or unable to give informed consent, or unable to return for scheduled protocol visits.
4) Patient who is already enrolled in another study or completed their participation in another study within 30 calendar days of the screening exam.
5) Known allergy to prostaglandin analogues
6) Previous history of lower eyelid blepharoplasty, dermal filler injection, or other treatment, for example dermal laser, intense pulse light, radiofrequency or topical drugs for treatment of eyebags
7) Known glaucoma patient who has used or will use topical prostaglandin as a form of treatment
8) Topical, periocular or intraocular steroid use or systemic steroid use anytime within three months of the procedure.
9) Active thyroid eye disease, any orbital inflammatory diseases, any orbital trauma, any orbital tumor.
10) Any ocular inflammations or other active ophthalmic conditions that could confound study results.
11) Ocular pathology or medical condition for which, in the investigator's judgment, the following factors would either place the subject at increased risk of complications or contraindicate device implantation or interfere with compliance to elements of the study protocol (e.g., ophthalmic examinations, follow-up visits),
a. uncontrolled systemic disease (e.g. diabetes, hypertension) that could compromise their participation in the study.
b. Disorders that pose a fall risk, as well as compromise ability to take a visual field exam and take glaucoma medications (e.g., Parkinson's disease),
c. inability to discontinue use of blood thinners within the surgeon’s standard preoperative or postoperative instructions.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Facial picture Day 0 ,Day 7, Week 4, Week 13, Week 16, Week 24 Digital camera

Secondary Outcome Measures

Name	Time	Method
niqueness Score Day 0 ,Day 7, Week 4, Week 13, Week 16, Week 24 Physical examination,Melanin Index Day 0 ,Day 7, Week 4, Week 13, Week 16, Week 24 Antera camera,Eyebags volume Day 0 ,Day 7, Week 4, Week 13, Week 16, Week 24 Antera camera,Patient Satisfaction Week 12, Week 24 Patient Satisfaction Score,intra-ocular pressure, visual acuity, conjunctival hyperemia, anterior chamber inflammation Day 0, Week 12, Week 24 ophthalmological examination,Pain score Day 0, Week 12 (after injection) Visual analogue scale