Intraductal Meibomian Gland Probing Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective, Randomized Clinical Trial of Meibomian Gland Probing Versus Sham Procedure for Refractory Meibomian Gland Dysfunction

Conditions
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Meibomian Gland Dysfunction

Intervention / Treatment
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* Drug: Blephamide
* Drug: GenTeal PM Night-Time
* Procedure: Meibomian Gland Probing
* Procedure: Sham Meibomian Gland Probing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Meibomian Gland Probing plus lubricant<br>Meibomian Gland Probing: Stainless steel probes were used to probe all the meibomian glands of upper lids of both eyes at the slit lamp. All patients were probed with a 1-mm probe followed by a 2-mm probe for all glands. Lubricant: GenTeal PM Night-Time Ointment (Alcon), a sterile ophthalmic lubricant that is commonly used to relieve symptoms in patients with dry eye disease, was applied topically to both eyes for 4 weeks with the following regimen: twice daily for 2 weeks and then once daily for 2 weeks. | Drug: GenTeal PM Night-Time<br> <br> * Other names: GenTeal PM Night-Time Ophthalmic Ointment Alcon;Procedure: Meibomian Gland Probing<br>* 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.<br>|
| Other: Sham Meibomian Gland Probing plus lubricant<br>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. | Drug: GenTeal PM Night-Time<br> <br> * Other names: GenTeal PM Night-Time Ophthalmic Ointment Alcon;Procedure: Sham Meibomian Gland Probing<br>* 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.<br>|
| Active Comparator: Meibomian Gland Probing plus Blephamide<br>Meibomian Gland Probing: Stainless steel probes were used to probe all the meibomian glands of upper lids of both eyes at the slit lamp. 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. | Drug: Blephamide<br> <br> * Other names: sulfacetamide sodium 10%/prednisolone acetate 0.2%, Allergan, Inc.;Procedure: Meibomian Gland Probing<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 4 week Time Point | 
| 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. | 4 week Time Point | 
| 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. | 4 week Time Point | 
| 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. | 4 week Time Point |