Clinical trial NCT02256969
Conditions: Meibomian Gland Dysfunction
Sponsor: Joseph B. Ciolino, MD
Start date: 2014-10-01; Completion date: 2015-08-01
Enrollment: 45 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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.

Arms: arm 1: 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. arm 2: 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. arm 3: 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.
Interventions: intervention 1: Blephamide intervention 2: GenTeal PM Night-Time intervention 3: Meibomian Gland Probing intervention 4: Sham Meibomian Gland Probing
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: For anesthesia, topical 3.5% lidocaine hydrochloride jelly (Akron) was applied directly with sterile cotton-tipped applicator to the lid margin for 3 times every 10 minutes before the procedure. If necessary, 2% lidocaine was 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.) were used to probe all the meibomian glands of upper lids of both eyes at the slit lamp. All patients were initially be probed with a 1-mm probe followed by a 2-mm probe for all glands. intervention 4: For anesthesia, topical 3.5% lidocaine hydrochloride jelly (Akron) was applied directly with sterile cotton-tipped applicator to the lid margin for 3 times every 10 minutes before the procedure. If necessary, 2% lidocaine was injected into the lid margin during the procedure to provide additional comfort. The patient's lid margin was touched with the probes without actual probing of the meibomian gland orifices.

Protocol documents: