Clinical trial NCT02256969: Intraductal Meibomian Gland Probing Trial
Official title: Prospective, Randomized Clinical Trial of Meibomian Gland Probing Versus Sham Procedure for Refractory Meibomian Gland Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Meibomian Gland Dysfunction
Lead sponsor: Massachusetts Eye and Ear Infirmary
Sponsor class: OTHER
First posted: 2014-10-06
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Ocular Surface Disease Index (OSDI)
timeFrame: 4 week Time Point
measure: Symptom Assessment in Dry Eye (SANDE)
timeFrame: 4 week Time Point
measure: Corneal Fluorescein Staining (CFS)
timeFrame: 4 week Time Point
measure: Tear Break Up Time (TBUT)
timeFrame: 4 week Time Point
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts Eye and Ear Infirmary
state: Massachusetts
Study officials:
affiliation: Massachusetts Eye and Ear Infirmary
name: Joseph B Ciolino, M. D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kheirkhah A, Kobashi H, Girgis J, Jamali A, Ciolino JB, Hamrah P. A randomized, sham-controlled trial of intraductal meibomian gland probing with or without topical antibiotic/steroid for obstructive meibomian gland dysfunction. Ocul Surf. 2020 Oct;18(4):852-856. doi: 10.1016/j.jtos.2020.08.008. Epub 2020 Aug 31.