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Hyaluronic Acid Gels for Lower Lid Retraction

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ClinicalTrials.gov Identifier: NCT01838252
Recruitment Status : Withdrawn
First Posted : April 24, 2013
Last Update Posted : December 3, 2014
Information provided by (Responsible Party):
Daniel Rootman, University of California, Los Angeles

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.

Condition or disease Intervention/treatment Phase
Ectropion Procedure: Hyaluronic acid Procedure: Saline Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : February 2013
Estimated Primary Completion Date : February 2014
Estimated Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Lower eyelid position [ Time Frame: 6 weeks ]
    Decrease in inferior scleral show

Secondary Outcome Measures :
  1. Subjective dry eye symptoms [ Time Frame: 6 weeks ]
    Ocular surface disease index score

  2. Objective dry eye signs [ Time Frame: 6 weeks ]
    NEI dry eye score

  3. Objective dry eye signs [ Time Frame: 6 weeks ]
    Oxford staining score

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01838252

United States, California
Jules Stein Eye Institute
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Principal Investigator: Daniel B Rootman, MD, MSc University of California, Los Angeles

Responsible Party: Daniel Rootman, MD, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01838252     History of Changes
Other Study ID Numbers: 12-001629
First Posted: April 24, 2013    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: December 2014

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

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