Suspended

Hyaluronic Acid Gels for Lower Lid Retraction

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What is being tested

Hyaluronic acid

+ Saline

Procedure
Who is being recruted

Conjunctival Diseases+8

+ Conjunctivitis

+ Corneal Diseases

From 21 to 65 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 4
Interventional
Study Start: February 2013
See protocol details

Summary

Principal SponsorUniversity of California, Los Angeles
Last updated: December 3, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2013

Actual date on which the first participant was enrolled.

Lid retraction is a difficult problem encountered in oculofacial plastic surgery. It can result from previous surgery, radiotherapy or cicatrizing disease or it may be idiopathic. Whatever the aetiology, the cosmetic appearance is troublesome to patients and, can be damaging to the cornea. The definitive therapy for lid retraction is surgical, and often involves complicated procedures including tissue grafting. Hyaluronic acid gels (HAG) have been FDA approved for the treatment of facial rhytids by subcutaneous injection and volume addition. These gels have gained wide popularity in for cosmetic applications in filling volume deficit areas. Functional applications in the periorbital area have also been described including the filling of volume deficit anophthalmic orbits, ectropion and loagophthalmos. Additionally, pilot studies have found HAG to be useful in correcting both upper and lower eyelid retraction, with good effect. The purpose of this investigation is to define the clinical utility of HAG correction of lower eyelid retraction in terms of anatomic (lid position), quantitative (dry eye signs on cornea) and qualitative effects (symptom severity). Our hypothesis is that HAG correction of lower eyelid retraction will improve patient comfort, clinical signs of dry eye and aesthetic self image.

Principal SponsorUniversity of California, Los Angeles
Last updated: December 3, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 21 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Conjunctival DiseasesConjunctivitisCorneal DiseasesEye DiseasesEyelid DiseasesKeratitisKeratoconjunctivitisLacrimal Apparatus DiseasesDry Eye SyndromesEctropionKeratoconjunctivitis Sicca

Criteria

2 inclusion criteria required to participate
Complaints of either significant ocular symptoms (OSDI > 13) or cosmetic deformity associated with the eyelid retraction

Lower eyelid retraction of > 1mm in one or both eyes

7 exclusion criteria prevent from participating
Age less than 21 years: due to lack of data on safety for HAG fillers in pediatric population

Age over 65 years of age: as HAG filler effect may be different in this population

Are pregnant or nursing: as there is little safety data on potential teratogenicity of HAG fillers

Currently active stage Thyroid Eye Disease

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Patients in this arm will receive hyaluronic acid fillers to the lower lid.

Group II

Sham

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Jules Stein Eye Institute

Los Angeles, United StatesOpen Jules Stein Eye Institute in Google Maps
SuspendedOne Study Center