Hyaluronic Acid Gels for Lower Lid Retraction

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by University of California, Los Angeles
Sponsor:
Information provided by (Responsible Party):
Daniel Rootman, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01838252
First received: April 18, 2013
Last updated: April 23, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Ectropion
Procedure: Hyaluronic acid
Procedure: Saline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Lower eyelid position [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Decrease in inferior scleral show


Secondary Outcome Measures:
  • Subjective dry eye symptoms [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Ocular surface disease index score

  • Objective dry eye signs [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    NEI dry eye score

  • Objective dry eye signs [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Oxford staining score


Estimated Enrollment: 52
Study Start Date: February 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hyaluronic acid
Patients in this arm will receive hyaluronic acid fillers to the lower lid.
Procedure: Hyaluronic acid
Hyaluronic acid filler will be injected in to the lower lid, elevating it to a more anatomic position
Other Name: Restylane
Sham Comparator: Saline Procedure: Saline
Saline will be injected in to the lower lid, elevating it to a more anatomic position

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Age less than 21 years: due to lack of data on safety for HAG fillers in pediatric population
  2. Age over 65 years of age: as HAG filler effect may be different in this population
  3. Are pregnant or nursing: as there is little safety data on potential teratogenicity of HAG fillers
  4. Have a demonstrated allergy to HAG fillers or lidocaine
  5. Have a current infection, skin sore, pimple, rash, hive or cyst over the injection site: to avoid worsening the infection or transmitting it
  6. Have a bleeding disorder or currently taking blood-thinning medications such as Coumadin or heparin on a daily basis.
  7. Currently active stage Thyroid Eye Disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01838252

Contacts
Contact: Dia Cervantes (310) 206-9727 cervantes@jsei.ucla.edu

Locations
United States, California
Jules Stein Eye Institute Recruiting
Los Angeles, California, United States, 90095
Contact: Dia Cervantes    310-206-9727    cervantes@jsei.ucla.edu   
Principal Investigator: Dan B Rootman, MD, MSc         
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Daniel B Rootman, MD, MSc University of California, Los Angeles
  More Information

No publications provided

Responsible Party: Daniel Rootman, MD, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01838252     History of Changes
Other Study ID Numbers: 12-001629
Study First Received: April 18, 2013
Last Updated: April 23, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, Los Angeles:
Ectropion
Hyaluronic Acid
Keratoconjunctivitis Sicca
Lower eyelid retraction

Additional relevant MeSH terms:
Ectropion
Eyelid Diseases
Eye Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Viscosupplements
Protective Agents

ClinicalTrials.gov processed this record on September 30, 2014