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NCT01738243 · ClinicalTrials.gov registry record · Phase 4
Hyaluronic Acid Gels for Upper Lid Retraction in Active Stage Thyroid Eye Disease
A Phase 4 study, sponsored by University of California, Los Angeles.
- Terminated
- Registry status
- Phase 4
- Development phase
- 2
- Enrollment target
NCT01738243: Clinical Trial Phase 4 study, sponsored by University of California, Los Angeles.
NCT01738243 is a Phase 4 study that was terminated before completion, run by University of California, Los Angeles. The registered enrollment target is 2 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01738243, a Phase 4 study, was terminated before completion, sponsored by University of California, Los Angeles.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 2 participants
- Enrollment target
Study 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 an
Primary Outcome
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.
Interventions
- DRUG Saline injection
- DRUG Hyaluronic Acid Gel injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2013-12 |
| Est. Completion | 2021-09 |
| Phase | Phase 4 |
Why NCT01738243 stopped before completion
NCT01738243 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 2 interventions - of which Saline injection is the first listed.
NCT01738243 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01738243 about?
NCT01738243 is a clinical study titled "Hyaluronic Acid Gels for Upper Lid Retraction in Active Stage Thyroid Eye Disease". 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: a...
What is the current status of trial NCT01738243?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 2 participants. The study started on 2013-12. Estimated completion is 2021-09.
What interventions are being tested in trial NCT01738243?
The interventions under investigation include: Saline injection (DRUG), Hyaluronic Acid Gel injection (DRUG).
Who is sponsoring clinical trial NCT01738243?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01738243's enrollment target sits among peer trials
2 1998th of 2000 higher than 1 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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