Meibomian Gland Dysfunction
Conditions
Brief summary
In this research study, the investigators are looking at the effects of Meibomian Gland Probing (MGP) versus a sham (fake) procedure in patients with refractory MGD who have already tried traditional management with no success in resolving their clinical signs (as seen by their ophthalmologist) or their symptoms. The investigators are also evaluating the effects of using two (2) post-procedural medication treatments: Blephamide or GenTeal PM Night-Time to determine if treatment after the MGP procedure has an effect on its outcome.
Detailed description
Dry eye disease is one of the most common conditions seen in ophthalmic practice and is associated with significant patient distress. Meibomian gland dysfunction (MGD) is among the most prevalent causes of dry eye disease. This condition, which is often due to obstruction of the meibomian gland orifices, may result in significant ocular irritation. Traditionally, management of MGD includes warm compress, lid hygiene, and anti-inflammatory medications. This randomized clinical trial is designed to evaluate the effects of meibomian gland probing versus sham procedure in cases with refractory MGD that do not respond to traditional treatments. Moreover, the effects of postoperative regimen will also be investigated using two different regimens. In addition to symptoms, the changes will also be evaluated in terms of clinical signs as well as in vivo confocal microscopy (IVCM) which allows study at the cellular level.
Interventions
DRUGBlephamide
DRUGGenTeal PM Night-Time
PROCEDUREMeibomian Gland Probing
For anesthesia, topical 3.5% lidocaine hydrochloride jelly (Akron) was applied directly with sterile cotton-tipped applicator to the lid margin for 3 times every 10 minutes before the procedure. If necessary, 2% lidocaine was injected into the lid margin during the procedure to provide additional comfort. After obtaining adequate anesthesia, the solid stainless steel probes (Maskin® Meibomian Gland Intraductal Probes, Rhein Medical Inc.) were used to probe all the meibomian glands of upper lids of both eyes at the slit lamp. All patients were initially be probed with a 1-mm probe followed by a 2-mm probe for all glands.
PROCEDURESham Meibomian Gland Probing
For anesthesia, topical 3.5% lidocaine hydrochloride jelly (Akron) was applied directly with sterile cotton-tipped applicator to the lid margin for 3 times every 10 minutes before the procedure. If necessary, 2% lidocaine was injected into the lid margin during the procedure to provide additional comfort. The patient's lid margin was touched with the probes without actual probing of the meibomian gland orifices.
Sponsors
Joseph B. Ciolino, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-89 years * Willing and able to provide written informed consent * Willing and able to comply with study assessments for the full duration of the study * Diagnosis of meibomian gland dysfunction (MGD) * Symptoms of MGD such as foreign body sensation, burning, stinging, light sensitivity for at least 3 months * Persistent symptoms despite at least 3 months of medical management including lid hygiene, warm compress, and use of topical and systemic therapy, or contraindication to systemic therapy * Presence of lid tenderness on the upper lids in both eyes * Tear break-up time (TBUT) of \<10 seconds * In good stable overall health
Exclusion criteria
* Active allergies to steroids, sulfacetamide, GenTeal PM Night-Time ointment, or lidocaine * Intraocular surgery or ocular laser surgery within 1 month before enrollment * History of ocular infection within 1 month before enrollment. * History of increased intraocular pressure after using topical steroids (steroid responsive) * Any condition (including language barrier) that precludes subject's ability to comply with study requirements including completion of study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Surface Disease Index (OSDI) | 4 week Time Point | A 12-question survey used to measure the symptoms of dry eye disease. Each of the 12 individual questions rate one symptom on a 0-4 scale, with 4 meaning that the symptom is present all of the time and 0 meaning the symptom is present none of the time. The overall ODSI score is calculated by adding all of the values from the 12 questions, multiplying that value by 25, and dividing the resulting value by the number of questions answered. This results in an overall scale that ranges from 0-100, with 100 being severe dry eye symptoms and 0 being no dry eye symptoms. |
| Symptom Assessment in Dry Eye (SANDE) | 4 week Time Point | A two-item survey used to assess the frequency and severity of dry eye disease. The SANDE score is calculated by taking the square root of the product of the frequency of symptoms score and the severity of symptoms score. The SANDE scale ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms. |
| Corneal Fluorescein Staining (CFS) | 4 week Time Point | Is used to assess the level of corneal epitheliopathy that is related to dry eye disease. The CFS scale ranges from 0 to 15 scale, with 0 representing the minimum level of corneal epitheliopathy and 15 representing the maximum level of epitheliopathy. |
| Tear Break Up Time (TBUT) | 4 week Time Point | TBUT measures the amount of time, in seconds, a dry spot appears in the tear film after each blink. Values less than 10 seconds are considered abnormal. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Meibomian Gland Probing Plus Lubricant Meibomian Gland Probing: Stainless steel probes were used to probe all the meibomian glands of upper lids of both eyes at the slit lamp.
Lubricant: GenTeal PM Night-Time Ointment, an ophthalmic lubricant that is used to relieve symptoms in patients with dry eye disease; was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks. | 13 |
| Sham Meibomian Gland Probing Plus Lubricant Sham Meibomian Gland Probing: The patient's the lid margin was touched with the probes without actual probing occurring.
Lubricant: GenTeal PM Night-Time Ointment, ophthalmic lubricant used to relieve symptoms in patients with dry eye disease, was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks. | 14 |
| Meibomian Gland Probing Plus Blephamide Meibomian Gland Probing: Stainless steel probes were used to probe the meibomian glands of upper lids of both eyes. All patients were probed with a 1-mm probe followed by a 2-mm probe for all glands.
Blephamide: is a combination of an antibiotic and an anti-inflammatory agent commonly used to treat various ocular conditions. Blephamide was applied topically to both eyes for 4 weeks with a regimen of: twice daily for 2 weeks and then once daily for 2 weeks. | 14 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Screenfailed or withdrew | 2 | 1 | 1 |
Baseline characteristics
| Characteristic | Meibomian Gland Probing Plus Lubricant | Sham Meibomian Gland Probing Plus Lubricant | Meibomian Gland Probing Plus Blephamide | Total |
|---|---|---|---|---|
| Age, Continuous | 59.6 years STANDARD_DEVIATION 13.7 | 63.9 years STANDARD_DEVIATION 13.8 | 59.8 years STANDARD_DEVIATION 17.4 | 61.1 years STANDARD_DEVIATION 15.2 |
| Corneal Fluorescein Staining (CFS) | 1.9 units on a scale STANDARD_DEVIATION 1.6 | 2.0 units on a scale STANDARD_DEVIATION 2 | 0.9 units on a scale STANDARD_DEVIATION 1 | 1.6 units on a scale STANDARD_DEVIATION 1.6 |
| Ocular Surface Disease Index (OSDI) | 45.3 units on a scale STANDARD_DEVIATION 23.8 | 49.1 units on a scale STANDARD_DEVIATION 27.1 | 49.1 units on a scale STANDARD_DEVIATION 19.9 | 47.9 units on a scale STANDARD_DEVIATION 23.3 |
| Sex: Female, Male Female | 10 Participants | 10 Participants | 9 Participants | 29 Participants |
| Sex: Female, Male Male | 3 Participants | 4 Participants | 5 Participants | 12 Participants |
| Symptom Assessment in Dry Eye (SANDE) | 68.7 units on a scale STANDARD_DEVIATION 15.4 | 61.8 units on a scale STANDARD_DEVIATION 22.5 | 72.1 units on a scale STANDARD_DEVIATION 14.1 | 67.5 units on a scale STANDARD_DEVIATION 17.8 |
| Tear Film Break-Up Time (TBUT) | 2.9 Seconds STANDARD_DEVIATION 1.5 | 3.0 Seconds STANDARD_DEVIATION 1.5 | 2.3 Seconds STANDARD_DEVIATION 2.5 | 3.0 Seconds STANDARD_DEVIATION 1.9 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 14 | 0 / 14 |
| other Total, other adverse events | 1 / 13 | 3 / 14 | 3 / 14 |
| serious Total, serious adverse events | 0 / 13 | 0 / 14 | 0 / 14 |
Outcome results
Primary
Corneal Fluorescein Staining (CFS)
Is used to assess the level of corneal epitheliopathy that is related to dry eye disease. The CFS scale ranges from 0 to 15 scale, with 0 representing the minimum level of corneal epitheliopathy and 15 representing the maximum level of epitheliopathy.
Time frame: 4 week Time Point
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meibomian Gland Probing Plus Lubricant | Corneal Fluorescein Staining (CFS) | 2.4 units on a scale | Standard Deviation 2.4 |
| Sham Meibomian Gland Probing Plus Lubricant | Corneal Fluorescein Staining (CFS) | 2.0 units on a scale | Standard Deviation 2.2 |
| Meibomian Gland Probing Plus Blephamide | Corneal Fluorescein Staining (CFS) | 1.4 units on a scale | Standard Deviation 2.1 |
Primary
Ocular Surface Disease Index (OSDI)
A 12-question survey used to measure the symptoms of dry eye disease. Each of the 12 individual questions rate one symptom on a 0-4 scale, with 4 meaning that the symptom is present all of the time and 0 meaning the symptom is present none of the time. The overall ODSI score is calculated by adding all of the values from the 12 questions, multiplying that value by 25, and dividing the resulting value by the number of questions answered. This results in an overall scale that ranges from 0-100, with 100 being severe dry eye symptoms and 0 being no dry eye symptoms.
Time frame: 4 week Time Point
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meibomian Gland Probing Plus Lubricant | Ocular Surface Disease Index (OSDI) | 38.7 units on a scale | Standard Deviation 20.3 |
| Sham Meibomian Gland Probing Plus Lubricant | Ocular Surface Disease Index (OSDI) | 36.9 units on a scale | Standard Deviation 28.2 |
| Meibomian Gland Probing Plus Blephamide | Ocular Surface Disease Index (OSDI) | 37.3 units on a scale | Standard Deviation 21 |
Primary
Symptom Assessment in Dry Eye (SANDE)
A two-item survey used to assess the frequency and severity of dry eye disease. The SANDE score is calculated by taking the square root of the product of the frequency of symptoms score and the severity of symptoms score. The SANDE scale ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.
Time frame: 4 week Time Point
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meibomian Gland Probing Plus Lubricant | Symptom Assessment in Dry Eye (SANDE) | 49.1 units on a scale | Standard Deviation 22.5 |
| Sham Meibomian Gland Probing Plus Lubricant | Symptom Assessment in Dry Eye (SANDE) | 50.2 units on a scale | Standard Deviation 27.6 |
| Meibomian Gland Probing Plus Blephamide | Symptom Assessment in Dry Eye (SANDE) | 47.6 units on a scale | Standard Deviation 25.5 |
Primary
Tear Break Up Time (TBUT)
TBUT measures the amount of time, in seconds, a dry spot appears in the tear film after each blink. Values less than 10 seconds are considered abnormal.
Time frame: 4 week Time Point
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meibomian Gland Probing Plus Lubricant | Tear Break Up Time (TBUT) | 3.5 Seconds | Standard Deviation 2.4 |
| Sham Meibomian Gland Probing Plus Lubricant | Tear Break Up Time (TBUT) | 4.2 Seconds | Standard Deviation 3 |
| Meibomian Gland Probing Plus Blephamide | Tear Break Up Time (TBUT) | 3.2 Seconds | Standard Deviation 2.9 |