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Intraductal Meibomian Gland Probing Trial

Information source: Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Meibomian Gland Dysfunction

Intervention: Blephamide (Drug); GenTeal PM Night-Time (Drug); Meibomian Gland Probing (Procedure); Sham Meibomian Gland Probing (Procedure)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Massachusetts Eye and Ear Infirmary

Official(s) and/or principal investigator(s):
Pedram Hamrah, M. D., Principal Investigator, Affiliation: Massachusetts Eye and Ear Infirmary

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Symptoms

Tear Break Up Time (TBUT)

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

Minimum age: 18 Years. Maximum age: 89 Years. Gender(s): Both.

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

Locations and Contacts

Massachusetts Eye and Ear Infirmary, Boston, Massachusetts 02114, United States
Additional Information

Starting date: October 2014
Last updated: July 27, 2015

Page last updated: August 23, 2015

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