Meibomian Gland DysfunctionNCT01917539
Efficacy of Pulsed Light Therapy for Meibomian Gland Dysfunction and Dry Eye Syndrome
A study testing Pulsed Light Therapy in people with Meibomian Gland Dysfunction and Dry Eye Syndrome, run by University of Miami at 1 site in United States.
Trial summary
Our primary aim is to determine whether pulsed light therapy (PLT) is effective in reducing symptoms and improving clinical stigmata of dry eye syndrome (DES) associated with meibomian gland dysfunction (MGD) in patients with facial rosacea (which includes ocular rosacea). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meibomian Gland Dysfunction, Dry Eye Syndrome
- What is being tested?
- Pulsed Light Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to May 2015
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater or equal to 18 y/o
- Patients presenting to academic referral center for DES
- Diagnosis of mild to moderate DES with meibomian gland dysfunction and ocular rosacea, based on evaluation of meibomian glands (MG), MG secretions, and other factors
- Facial rosacea
- Patients must not have started any new medications within the past 1 month
- Patients should not be using warm compresses or lid scrubs more than 1-2 times in the previous 2 weeks
- Symptomatic changes in DES
Who cannot join
- Age < 18
- History of inflammatory DES (e.g. Sjogren's, rheumatoid arthritis, Stevens-Johnson syndrome, ocular cicatricial pemphigoid)
- History of trauma-induced ocular surface disease (thermal burns, chemical burns)
- Severe DES
- Pregnant women
- H/o seizures
Show all 11Show fewer
- Significant unprotected sun exposure or use of tanning beds or creams in treated area (must be discontinued at least 2 weeks prior to treatment, during treatment course, and 2 weeks after last treatment)
- Use of Accutane, anti-coagulants, or St. John's Wort
- Active infections/immunosuppression
- Herpes 1 or 2 within the treatment area
- Patients who have undergone LASIK surgery within the past 12 months
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami Bascom Palmer Eye Institute
Miami, Florida, 33136
About this study
Our primary aim is to determine whether pulsed light therapy (PLT) is effective in reducing symptoms and improving clinical stigmata of dry eye syndrome (DES) associated with meibomian gland dysfunction (MGD) in patients with facial rosacea (which includes ocular rosacea). The uses of PLT are for treatment of rosacea, hair removal, pigmented lesions, and skin telangiectasias. The risks include the potential for transient sunburn-like sensations (i.e. redness, burning sensation) and particularly if not used properly, the potential to cause burns, blistering, scarring, and pigmentary changes.
Read the detailed description
Group 1: pre-existing dry eye treatment regimen + sham light treatment. Sham light treatment will consist of applying the usual eye shields used for PLT, applying the usual skin gel to the facial region, and applying the cooling probe without application of pulsed light therapy treatment.
Group 2: pre-existing dry eye treatment regimen + pulsed light therapy (PLT)
Subjects will be recruited from the outpatient clinics at Bascom Palmer Eye Institute, will have a chief complaint of dry eyes, and will have to meet all inclusion/exclusion criteria. Subjects will be randomized via computerassisted random number generation to Group 1 or 2. All subjects will undergo baseline evaluation for DES including a standardized questionnaire about symptoms of dry eyes (takes about 5 minutes to complete and assesses the presence and severity of dry eye symptoms), various testing on the properties and composition of the tear film, grading of changes related to dry eye seen on the surface of the eye, and grading of the oil glands on the eyelid (meibomian glands) and their secretions. Primary outcomes will be anatomical improvement of the meibomian glands and their secretions.
Subjects in Group 1 will continue their pre-existing dry eye treatment regimen and receive sham light treatment, whereas subjects in Group 2 will continue their pre-existing dry eye treatment regimen and receive PLT. All subjects will come for their initial visit where evaluation and treatment #1 will take place. They will also attend 3 follow-up visits spaced approximately 3-4 weeks apart during which they will have subsequent treatments and/or evaluations for their dry eyes. The visit duration will range from approximately 60-90 minutes per clinic visit.
The PLT devices are FDA approved for the treatment of rosacea in the periocular/facial region, and having facial rosacea is one of the inclusion criteria for this study. This is the indication for treatment with PLT. The devices are not FDA-approved for the treatment of DES, although this is something we will be looking at as one of our main outcomes.
- Conditions
- Meibomian Gland Dysfunction, Dry Eye Syndrome
- Being tested
- Sham Treatment, Pulsed Light Therapy
- Medical subject headings
- Meibomian Gland Dysfunction, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham TreatmentDevice
Sham light treatment will consist of applying the usual eye shields used for PLT, applying the usual skin gel to the facial region, and applying the cooling probe without application of pulsed light therapy treatment.
Pulsed Light TherapyDevice
Light treatment will consist of applying eye shields used for PLT, applying the skin gel to the facial region, and applying the probe with application of pulsed light therapy treatment.
| Study group | Role | What they receive |
|---|---|---|
| Sham Treatment | Sham comparator | Sham light treatment will consist of applying the usual eye shields used for PLT, applying the usual skin gel to the facial region, and applying the cooling probe without application of pulsed light therapy treatment. All subjects will come for their initial visit where evaluation and treatment #1 will take place. They will also attend 3 follow-up visits spaced approximately 3-4 weeks apart during which they will have subsequent treatments and/or evaluations for their dry eyes. The visit duration will range from approximately 60-90 minutes per clinic visit. Receives: Device: Sham Treatment |
| Pulsed Light Therapy | Experimental | All subjects will come for their initial visit where evaluation and treatment #1 will take place. They will also attend 3 follow-up visits spaced approximately 3-4 weeks apart during which they will have subsequent treatments and/or evaluations for their dry eyes. The visit duration will range from approximately 60-90 minutes per clinic visit. Receives: Device: Pulsed Light Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anatomical improvement of the meibomian glands and their secretions.
We are looking at subjective changes in DES symptomatology based on the OSDI questionnaire score. We are also looking at objective changes in examination findings based on the tear film properties (TBUT, Schirmer), staining patterns of the ocular surface using fluor. and LG dyes, characteristics of the meibomian glands and lid margin (e.g. telangiectasias, notching, myelography by transillumination, etc), as well as the meibum secretions (e.g. expressibility, and consistency).
Change in baseline for OSDI, TBUT in seconds, Schirmer testing in mm, staining pattern score (standardized proprietary score on a scale of 1-4), myelography by % of meibomian glands that can be transilluminated, expressibility/consistency (proprietary score on scale of 1-4) will be measured.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2013 (estimated)
- Study startJun 2013
- Primary completionMay 2015
- Study completionMay 2015
Why it stopped: Trouble enrolling patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meibomian Gland DysfunctionStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Wendy Lee, University of Miami
- Investigators
- Wendy Lee, MD, Principal investigator, University of Miami Bascom Palmer Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01917539
- Sponsor's protocol ID
- 20120140
- Status last verified
- Jun 2018
- First submitted
- 19 Jul 2013
- Last updated
- 28 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Pulsed Light Therapy for Meibomian Gland Dysfunction and Dry Eye Syndrome
- ClinicalTrials.gov ID
- NCT01917539
- Acronym / sponsor ID
- 20120140
- Conditions
- Meibomian Gland Dysfunction, Dry Eye Syndrome
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Trouble enrolling patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 6 Aug 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.
Our primary aim is to determine whether pulsed light therapy (PLT) is effective in reducing symptoms and improving clinical stigmata of dry eye syndrome (DES) associated with meibomian gland dysfunction (MGD) in patients with facial rosacea (which includes ocular rosacea). The uses of PLT are for treatment of rosacea, hair removal, pigmented lesions, and skin telangiectasias. The risks include the potential for transient sunburn-like sensations (i.e. redness, burning sensation) and particularly if not used properly, the potential to cause burns, blistering, scarring, and pigmentary changes.
Detailed description
Group 1: pre-existing dry eye treatment regimen + sham light treatment. Sham light treatment will consist of applying the usual eye shields used for PLT, applying the usual skin gel to the facial region, and applying the cooling probe without application of pulsed light therapy treatment.
Group 2: pre-existing dry eye treatment regimen + pulsed light therapy (PLT)
Subjects will be recruited from the outpatient clinics at Bascom Palmer Eye Institute, will have a chief complaint of dry eyes, and will have to meet all inclusion/exclusion criteria. Subjects will be randomized via computerassisted random number generation to Group 1 or 2. All subjects will undergo baseline evaluation for DES including a standardized questionnaire about symptoms of dry eyes (takes about 5 minutes to complete and assesses the presence and severity of dry eye symptoms), various testing on the properties and composition of the tear film, grading of changes related to dry eye seen on the surface of the eye, and grading of the oil glands on the eyelid (meibomian glands) and their secretions. Primary outcomes will be anatomical improvement of the meibomian glands and their secretions.
Subjects in Group 1 will continue their pre-existing dry eye treatment regimen and receive sham light treatment, whereas subjects in Group 2 will continue their pre-existing dry eye treatment regimen and receive PLT. All subjects will come for their initial visit where evaluation and treatment #1 will take place. They will also attend 3 follow-up visits spaced approximately 3-4 weeks apart during which they will have subsequent treatments and/or evaluations for their dry eyes. The visit duration will range from approximately 60-90 minutes per clinic visit.
The PLT devices are FDA approved for the treatment of rosacea in the periocular/facial region, and having facial rosacea is one of the inclusion criteria for this study. This is the indication for treatment with PLT. The devices are not FDA-approved for the treatment of DES, although this is something we will be looking at as one of our main outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham Treatment | Sham comparator | Device: Sham TreatmentSham light treatment will consist of applying the usual eye shields used for PLT, applying the usual skin gel to the facial region, and applying the cooling probe without application of pulsed light therapy treatment. All subjects will come for their initial visit where evaluation and treatment #1 will take place. They will also attend 3 follow-up visits spaced approximately 3-4 weeks apart during which they will have subsequent treatments and/or evaluations for their dry eyes. The visit duration will range from approximately 60-90 minutes per clinic visit. |
| Pulsed Light Therapy | Experimental | Device: Pulsed Light TherapyAll subjects will come for their initial visit where evaluation and treatment #1 will take place. They will also attend 3 follow-up visits spaced approximately 3-4 weeks apart during which they will have subsequent treatments and/or evaluations for their dry eyes. The visit duration will range from approximately 60-90 minutes per clinic visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age greater or equal to 18 y/o
- Patients presenting to academic referral center for DES
- Diagnosis of mild to moderate DES with meibomian gland dysfunction and ocular rosacea, based on evaluation of meibomian glands (MG), MG secretions, and other factors
- Facial rosacea
- Patients must not have started any new medications within the past 1 month
Key exclusion criteria (11 listed)
- Age < 18
- History of inflammatory DES (e.g. Sjogren's, rheumatoid arthritis, Stevens-Johnson syndrome, ocular cicatricial pemphigoid)
- History of trauma-induced ocular surface disease (thermal burns, chemical burns)
- Severe DES
- Pregnant women
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 |
|---|---|---|
| Sham TreatmentSham light treatment will consist of applying the usual eye shields used for PLT, applying the usual skin gel to the facial region, and applying the cooling probe without application of pulsed light therapy treatment. | Device | Sham Treatment |
| Pulsed Light TherapyLight treatment will consist of applying eye shields used for PLT, applying the skin gel to the facial region, and applying the probe with application of pulsed light therapy treatment. | Device | Pulsed Light Therapy |
Primary outcome
Anatomical improvement of the meibomian glands and their secretions.
Time frame: 3 months
We are looking at subjective changes in DES symptomatology based on the OSDI questionnaire score. We are also looking at objective changes in examination findings based on the tear film properties (TBUT, Schirmer), staining patterns of the ocular surface using fluor. and LG dyes, characteristics of the meibomian glands and lid margin (e.g. telangiectasias, notching, myelography by transillumination, etc), as well as the meibum secretions (e.g. expressibility, and consistency). Change in baseline for OSDI, TBUT in seconds, Schirmer testing in mm, staining pattern score (standardized proprietary score on a scale of 1-4), myelography by % of meibomian glands that can be transilluminated, expressibility/consistency (proprietary score on scale of 1-4) will be measured.
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 28 Jun 2018.
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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.
Wendy Lee, MD principal investigator
University of Miami Bascom Palmer Eye Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed Light Therapy in people with Meibomian Gland Dysfunction and Dry Eye Syndrome, run by University of Miami 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 7 inclusion and 11 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 28 Jun 2018. 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.
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?
Anatomical improvement of the meibomian glands and their secretions. (time frame: 3 months). 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 28 Jun 2018.