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Hyaluronic Acid Gels for Lower Lid Retraction

Primary Purpose

Ectropion

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Hyaluronic acid
Saline
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ectropion focused on measuring Ectropion, Hyaluronic Acid, Keratoconjunctivitis Sicca, Lower eyelid retraction

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jules Stein Eye Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Hyaluronic acid

Saline

Arm Description

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

Outcomes

Primary Outcome Measures

Lower eyelid position
Decrease in inferior scleral show

Secondary Outcome Measures

Subjective dry eye symptoms
Ocular surface disease index score
Objective dry eye signs
NEI dry eye score
Objective dry eye signs
Oxford staining score

Full Information

First Posted
April 18, 2013
Last Updated
December 2, 2014
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT01838252
Brief Title
Hyaluronic Acid Gels for Lower Lid Retraction
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Withdrawn
Study Start Date
February 2013 (undefined)
Primary Completion Date
February 2014 (Anticipated)
Study Completion Date
May 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ectropion
Keywords
Ectropion, Hyaluronic Acid, Keratoconjunctivitis Sicca, Lower eyelid retraction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hyaluronic acid
Arm Type
Experimental
Arm Description
Patients in this arm will receive hyaluronic acid fillers to the lower lid.
Arm Title
Saline
Arm Type
Sham Comparator
Intervention Type
Procedure
Intervention Name(s)
Hyaluronic acid
Other Intervention Name(s)
Restylane
Intervention Description
Hyaluronic acid filler will be injected in to the lower lid, elevating it to a more anatomic position
Intervention Type
Procedure
Intervention Name(s)
Saline
Intervention Description
Saline will be injected in to the lower lid, elevating it to a more anatomic position
Primary Outcome Measure Information:
Title
Lower eyelid position
Description
Decrease in inferior scleral show
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Subjective dry eye symptoms
Description
Ocular surface disease index score
Time Frame
6 weeks
Title
Objective dry eye signs
Description
NEI dry eye score
Time Frame
6 weeks
Title
Objective dry eye signs
Description
Oxford staining score
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel B Rootman, MD, MSc
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jules Stein Eye Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

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Hyaluronic Acid Gels for Lower Lid Retraction

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