Hyaluronic Acid Gels for Lower Lid Retraction

NCT01838252 | Withdrawn Phase 4

• 1 other identifier: 12-001629
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ectropion

Keywords

Ectropion; Hyaluronic Acid; Keratoconjunctivitis Sicca; Lower eyelid retraction

Outcome Measures

Primary Outcomes (1)

• Lower eyelid position

  Decrease in inferior scleral show

  6 weeks

Secondary Outcomes (3)

• Subjective dry eye symptoms

  6 weeks

• Objective dry eye signs

  6 weeks

• Objective dry eye signs

  6 weeks

Study Arms (2)

Hyaluronic acid

EXPERIMENTAL

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

Procedure: Hyaluronic acid

Saline

SHAM COMPARATOR

Procedure: Saline

Interventions

Hyaluronic acid PROCEDURE

Hyaluronic acid filler will be injected in to the lower lid, elevating it to a more anatomic position

Also known as: Restylane

Hyaluronic acid

Saline PROCEDURE

Saline will be injected in to the lower lid, elevating it to a more anatomic position

Saline

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Lower eyelid retraction of \>1mm in one or both eyes.
• Complaints of either significant ocular symptoms (OSDI\>13) or cosmetic deformity associated with the eyelid retraction.

You may not qualify if:

• 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
• Have a demonstrated allergy to HAG fillers or lidocaine
• Have a current infection, skin sore, pimple, rash, hive or cyst over the injection site: to avoid worsening the infection or transmitting it
• Have a bleeding disorder or currently taking blood-thinning medications such as Coumadin or heparin on a daily basis.
• Currently active stage Thyroid Eye Disease

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

Jules Stein Eye Institute

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Ectropion; Keratoconjunctivitis Sicca

Interventions

Hyaluronic Acid; Restylane; Sodium Chloride

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Daniel B Rootman, MD, MSc

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 18, 2013
• First Posted: April 24, 2013
• Study Start: February 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: May 1, 2014
• Last Updated: December 3, 2014

Record last verified: 2014-12

Locations

US (1)