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Hyaluronic Acid Gels for Upper Lid Retraction in Active Stage Thyroid Eye Disease (HALR)

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ClinicalTrials.gov Identifier: NCT01738243
Recruitment Status : Recruiting
First Posted : November 30, 2012
Last Update Posted : April 3, 2019
Sponsor:
Information provided by (Responsible Party):
Daniel Rootman, University of California, Los Angeles

Tracking Information
First Submitted Date  ICMJE October 6, 2012
First Posted Date  ICMJE November 30, 2012
Last Update Posted Date April 3, 2019
Study Start Date  ICMJE December 2013
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 27, 2012)
Upper eyelid scleral show and marginal reflex distance 1 in mm [ Time Frame: 6 weeks after injection ]
Physicians will measure the amount of lid retraction (upper eyelid scleral show, marginal reflex distance 1) present in study participants 6 weeks following injection of hyaluronic acid gel vs. saline.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01738243 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 1, 2012)
  • Dry Eye [ Time Frame: 6 weeks post injection. ]
    We will measure severity of dry eye signs using the Oxford staining scale and the Ocular surface disease index
  • Quality of life [ Time Frame: 6 weeks ]
    The Graves Orbitopathy Quality of Life (GO-QOL) survey will be given to subjects at entry and at 6 weeks.
  • Complications [ Time Frame: 6 weeks ]
    Complications including null effect, ecchymosis, retrobulbar hemorrhage, cranial nerve injury and extraocular muscle dysfunction will be monitored and reported
Original Secondary Outcome Measures  ICMJE
 (submitted: November 27, 2012)
  • Dry Eye [ Time Frame: 6 weeks post injection. ]
    We will measure severity of dry eye signs using the Oxford staining scale and the Ocular surface disease index
  • Quality of life [ Time Frame: 6 weeks ]
    The Graves Orbitopathy Quality of Life (GO-QOL) survey will be given to subjects at entry and at 6 weeks.
  • Complications [ Time Frame: 6 weeks ]
    Complications including null effect, eccemosis, retrobulbar hemorrhage, cranial nerve injury and extraocular muscle dysfunction will be monitored and reported
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hyaluronic Acid Gels for Upper Lid Retraction in Active Stage Thyroid Eye Disease
Official Title  ICMJE Phase IV Study of Hyaluronic Acid Gels for Upper Lid Retraction in Active Stage Thyroid Eye Disease
Brief Summary

Thyroid eye disease (TED) is an autoimmune disease that affects the eye area. The disease presents with a variety of physical findings, including bulging of the eyes (proptosis), upper and lower eyelid retraction, and swelling/inflammation of the eye itself.

The disease passes through two phases: active and inactive. The active phase lasts between 18 and 24 months. During this phase, TED signs and symptoms generally worsen and then often improve. The inactive phase follows, during which the signs and symptoms of TED cease to improve and usually stabilize.

Lid retraction is a cardinal sign of TED. In addition to potentially causing cornea damage due to improper lid closure, lid retraction is also very troublesome for patients due to its cosmetic appearance. The precise pathophysiology of lid retraction is poorly understood, but a leading hypothesis is that it occurs due to scarring and fibrosis in the muscles that lift the eyelid.

Currently, the definitive treatment for lid retraction is surgery, which can be used to lengthen the lid itself or remove inflamed tissue from behind the eye, thus causing the eye to bulge less. In cases when patients first present to their physician with corneal ulceration or compression of the optic nerve, surgery may be performed immediately. However, in most instances, surgical procedures are delayed until the active stage of the disease has passed. Thus, most patients must endure the cosmetic and irritant symptoms of TED for up to two years.

Hyaluronic Acid Gels (HAG) have been FDA approved for the treatment of facial rhytids (wrinkles). They are injected under the skin and work by increasing volume. Recently, some smaller retrospective research studies have shown that HAG is also effective in correcting upper and lower eyelid retraction in TED. Hence, HAG may be for patients with active stage TED. It is also thought that if employed early in active phase disease, HAG may also help to decrease the severity of associated symptoms and reduce the need for surgery.

The purpose of the current investigation is to define the clinical utility of HAG correction of upper eyelid in active TED in terms of anatomic (lid position), quantitative (corneal dry eye signs) and qualitative effects (symptom severity and thyroid related quality of life).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Thyroid Eye Disease
Intervention  ICMJE
  • Drug: Hyaluronic Acid Gel injection
    The conjunctiva is anesthetized with Proparacaine Hydrochloride Ophthalmic Solution, 0.5%. The upper eyelid is everted and the conjunctiva just superior to the upper tarsal edge is exposed. Using a 30-gauge needle, a single bolus of Hyaluronic Acid Gel is placed centrally in the subconjunctival levator-Muller plane. Small volumes (0.1 to 0.2 ml) of Hyaluronic Acid Gel are injected with the end point being adequate lowering with improved symmetry.
    Other Names:
    • Restylane
    • Belotero
  • Drug: Saline injection
    The conjunctiva is anesthetized with Proparacaine Hydrochloride Ophthalmic Solution, 0.5%. The upper eyelid is everted and the conjunctiva just superior to the upper tarsal edge is exposed. Using a 30-gauge needle, a single bolus of saline is placed centrally in the subconjunctival levator-Muller plane. Small volumes (0.1 to 0.2 ml) of saline are injected with the end point being adequate lowering with improved symmetry.
    Other Name: Normal saline
Study Arms  ICMJE
  • Experimental: Unilateral Upper Eyelid Retraction

    This arm will consist of participants with unilateral upper eye lid retraction secondary to thyroid eye disease (TED).

    Patients enrolled will be randomized 1:1 to Hyaluronic Acid Gel Injection or Saline injection

    Interventions:
    • Drug: Hyaluronic Acid Gel injection
    • Drug: Saline injection
  • Experimental: Bilateral Upper Eyelid Retraction

    This arm will consist of participants with bilateral upper eye lid retraction secondary to thyroid eye disease (TED).

    Patients enrolled will be randomized 1:1 to Hyaluronic Acid Gel injection or Saline injection

    Interventions:
    • Drug: Hyaluronic Acid Gel injection
    • Drug: Saline injection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 27, 2012)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2021
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Active stage TO as determined by symptom onset of under 9 months.
  2. Upper eyelid retraction of 1mm or greater in one or both eyes.
  3. Complaints of either significant ocular symptoms (despite appropriate use of ocular lubricants), 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, heparin or acetylsalicylic acid on a daily basis.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01738243
Other Study ID Numbers  ICMJE PRE#12-003174
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Daniel Rootman, University of California, Los Angeles
Study Sponsor  ICMJE University of California, Los Angeles
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Daniel Rootman University of California, Los Angeles
PRS Account University of California, Los Angeles
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP