Intraductal Meibomian Gland Probing Trial (MGP)

Joseph B. Ciolino, MD

Status and phase: Completed; Phase 4

Conditions: Meibomian Gland Dysfunction

Treatments: Procedure: Sham Meibomian Gland Probing; Drug: Blephamide; Procedure: Meibomian Gland Probing; Drug: GenTeal PM Night-Time

Study type: Interventional

Funder types: Other

Identifiers

NCT02256969

14-059H

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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45 participants in 3 patient groups

Meibomian Gland Probing plus lubricant

Other group

Description:

Meibomian Gland Probing: Stainless steel probes were used to probe all the meibomian glands of upper lids of both eyes at the slit lamp. All patients were probed with a 1-mm probe followed by a 2-mm probe for all glands. Lubricant: GenTeal PM Night-Time Ointment (Alcon), a sterile ophthalmic lubricant that is commonly used to relieve symptoms in patients with dry eye disease, was applied topically to both eyes for 4 weeks with the following regimen: twice daily for 2 weeks and then once daily for 2 weeks.

Treatment:

Procedure: Meibomian Gland Probing

Drug: GenTeal PM Night-Time

Sham Meibomian Gland Probing plus lubricant

Other group

Description:

Sham Meibomian Gland Probing: The patient's the lid margin was touched with the probes without actual probing occurring. Lubricant: GenTeal PM Night-Time Ointment, ophthalmic lubricant used to relieve symptoms in patients with dry eye disease, was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks.

Treatment:

Procedure: Sham Meibomian Gland Probing

Drug: GenTeal PM Night-Time

Meibomian Gland Probing plus Blephamide

Active Comparator group

Description:

Meibomian Gland Probing: Stainless steel probes were used to probe all the meibomian glands of upper lids of both eyes at the slit lamp. All patients were probed with a 1-mm probe followed by a 2-mm probe for all glands. Blephamide: is a combination of an antibiotic and an anti-inflammatory agent commonly used to treat various ocular conditions. Blephamide was applied topically to both eyes for 4 weeks with a regimen of: twice daily for 2 weeks and then once daily for 2 weeks.

Treatment:

Procedure: Meibomian Gland Probing

Drug: Blephamide