Intraductal Meibomian Gland Probing Trial
Condition: Meibomian Gland Dysfunction
MeSH terms: Meibomian Gland Dysfunction
Intervention: Blephamide; GenTeal PM Night-Time; Meibomian Gland Probing; Sham Meibomian Gland Probing
Intervention description: 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.; 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.
Intervention MeSH terms: Sulfacetamide; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Mineral Oil; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Maximum age: 89 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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