Status:
COMPLETED
Intraductal Meibomian Gland Probing Trial
Lead Sponsor:
Joseph B. Ciolino, MD
Conditions:
Meibomian Gland Dysfunction
Eligibility:
All Genders
18-89 years
Phase:
PHASE4
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 ...
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 caus...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT02256969
Start Date
October 1 2014
End Date
August 1 2015
Last Update
June 19 2017
Active Locations (1)
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1
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States, 02114