EctropionPhase 4NCT01838252
Hyaluronic Acid Gels for Lower Lid Retraction
A Phase 4 study testing Hyaluronic acid and Saline in people with Ectropion, run by University of California, Los Angeles at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Ectropion
- What is being tested?
- Hyaluronic acid and Saline
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to May 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Jules Stein Eye Institute
Los Angeles, California, 90095
About this study
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.
Read more
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.
- Conditions
- Ectropion
- Being tested
- Hyaluronic acid, Saline
- Keywords
- Ectropion, Hyaluronic Acid, Keratoconjunctivitis Sicca, Lower eyelid retraction
- Medical subject headings
- Ectropion, Keratoconjunctivitis Sicca
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic acidProcedure or surgery
Also called Restylane
Hyaluronic acid filler will be injected in to the lower lid, elevating it to a more anatomic position
SalineProcedure or surgery
Saline will be injected in to the lower lid, elevating it to a more anatomic position
| Study group | Role | What they receive |
|---|---|---|
| Hyaluronic acid | Experimental | Patients in this arm will receive hyaluronic acid fillers to the lower lid. Receives: Procedure: Hyaluronic acid |
| Saline | Sham comparator | Not described Receives: Procedure: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower eyelid position
Decrease in inferior scleral show
Measured: 6 weeks
Secondary outcomes (3)
Subjective dry eye symptoms
Ocular surface disease index score
Measured: 6 weeks
Objective dry eye signs
NEI dry eye score
Measured: 6 weeks
Objective dry eye signs
Oxford staining score
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2013 (estimated)
- Study startFeb 2013
- Primary completionFeb 2014 (estimated)
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EctropionStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Rootman, University of California, Los Angeles
- Investigators
- Daniel B Rootman, MD, MSc, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01838252
- Sponsor's protocol ID
- 12-001629
- Status last verified
- Dec 2014
- First submitted
- 18 Apr 2013
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyaluronic Acid Gels for Lower Lid Retraction
- ClinicalTrials.gov ID
- NCT01838252
- Acronym / sponsor ID
- 12-001629
- Conditions
- Ectropion
- Keywords
- Ectropion, Hyaluronic Acid, Keratoconjunctivitis Sicca, Lower eyelid retraction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Feb 2014 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 24 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyaluronic acid | Experimental | Procedure: Hyaluronic acidPatients in this arm will receive hyaluronic acid fillers to the lower lid. |
| Saline | Sham comparator | Procedure: Saline |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyaluronic acidAlso: RestylaneHyaluronic acid filler will be injected in to the lower lid, elevating it to a more anatomic position | Procedure or surgery | Hyaluronic acid |
| SalineSaline will be injected in to the lower lid, elevating it to a more anatomic position | Procedure or surgery | Saline |
Primary outcome
Lower eyelid position
Time frame: 6 weeks
Decrease in inferior scleral show
3 secondary outcomes
Subjective dry eye symptoms
Time frame: 6 weeks
Objective dry eye signs
Time frame: 6 weeks
Objective dry eye signs
Time frame: 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2014.
Related trials for Ectropion
Not yet recruiting
A Trial to Evaluate Two Ectropion Preventive Measures Using the Subciliary Approach in Orbital Fracture Surgery.
Orbital Fractures, Orbital Floor Fractures
RecruitingObservational study
Development of a Mobile Terminal-Based Intelligent Detection System for Multiple Anterior Segment Diseases of the Eye
Artifical Intelligence, Cataract
Recruiting
Steri-Strip Tape Use in Unilateral Ectropion Surgery
Ectropion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel B Rootman, MD, MSc principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hyaluronic acid and Saline in people with Ectropion, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower eyelid position (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2014.