Hyaluronic Acid Gels for Lower Lid Retraction

Ectropion Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01838252
• Other study ID #: 12-001629
• Status: Withdrawn
• Phase: Phase 4
• First received: April 18, 2013
• Last updated: December 2, 2014
• Start date: February 2013
• Est. completion date: May 2014

Study information

• Verified date: December 2014
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Ectropion

Intervention

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

Locations

Country	Name	City	State
United States	Jules Stein Eye Institute	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lower eyelid position	Decrease in inferior scleral show	6 weeks	No
Secondary	Subjective dry eye symptoms	Ocular surface disease index score	6 weeks	No
Secondary	Objective dry eye signs	NEI dry eye score	6 weeks	No
Secondary	Objective dry eye signs	Oxford staining score	6 weeks	No