Intraductal Meibomian Gland Probing Trial

Meibomian Gland Dysfunction Clinical Trial

— MGP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02256969
• Other study ID #: 14-059H
• Status: Completed
• Phase: Phase 4
• First received: August 13, 2014
• Last updated: December 19, 2016
• Start date: October 2014
• Est. completion date: August 2015

Study information

• Verified date: October 2014
• Source: Massachusetts Eye and Ear Infirmary
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 89 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Meibomian Gland Dysfunction

Intervention

Drug:
• Blephamide

• GenTeal PM Night-Time

Procedure:
• Meibomian Gland Probing
For anesthesia, topical 3.5% lidocaine hydrochloride jelly (Akron) will be applied directly with sterile cotton-tipped applicator to the lid margin for 3 times every 10 minutes before the procedure. If necessary, 2% lidocaine will be 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.) will be used to probe all the meibomian glands of upper lids of both eyes at the slit lamp. All patients will initially be probed with a 1-mm probe followed by a 2-mm probe for all glands.
• Sham Meibomian Gland Probing
For anesthesia, topical 3.5% lidocaine hydrochloride jelly (Akron) will be applied directly with sterile cotton-tipped applicator to the lid margin for 3 times every 10 minutes before the procedure. If necessary, 2% lidocaine will be injected into the lid margin during the procedure to provide additional comfort. The patient's lid margin will be touched with the probes without actual probing of the meibomian gland orifices.

Locations

Country	Name	City	State
United States	Massachusetts Eye and Ear Infirmary	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts Eye and Ear Infirmary

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptoms	Symptoms will be assessed using the Ocular Surface Disease Index (OSDI) questionnaire and the Symptom Assessment iN Dry Eye (SANDE) questionnaire	1 Month	No
Primary	Tear Break Up Time (TBUT)	TBUT will be assessed using fluorescein staining	1 month	No