MGP: Intraductal Meibomian Gland Probing Trial

• Sponsor: Joseph B. Ciolino, MD (Other)
• Overall Status: Completed
• CT.gov ID: NCT02256969
• Collaborator: (none)
• Enrollment: 45
• Location: 1
• Arms: 3
• Duration (Months): 10
• Patients Per Site Per Month: 4.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Meibomian Gland Dysfunction	Drug: Blephamide; Drug: GenTeal PM Night-Time; Procedure: Meibomian Gland Probing; Procedure: Sham Meibomian Gland Probing	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 45 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Prospective, Randomized Clinical Trial of Meibomian Gland Probing Versus Sham Procedure for Refractory Meibomian Gland Dysfunction
• Study Start Date: Oct 1, 2014
• Actual Primary Completion Date: Aug 1, 2015
• Actual Study Completion Date: Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Other: Meibomian Gland Probing plus lubricant 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.	Drug: GenTeal PM Night-Time; Other Names: GenTeal PM Night-Time Ophthalmic Ointment Alcon ; Procedure: Meibomian Gland Probing; 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.
Other: Sham Meibomian Gland Probing plus lubricant 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.	Drug: GenTeal PM Night-Time; Other Names: GenTeal PM Night-Time Ophthalmic Ointment Alcon ; Procedure: Sham Meibomian Gland Probing; 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.
Active Comparator: Meibomian Gland Probing plus Blephamide 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.	Drug: Blephamide; Other Names: sulfacetamide sodium 10%/prednisolone acetate 0.2%, Allergan, Inc. ; Procedure: Meibomian Gland Probing; 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.

Outcome Measures

Primary Outcome Measures

1. Ocular Surface Disease Index (OSDI) [4 week Time Point]

   A 12-question survey used to measure the symptoms of dry eye disease. Each of the 12 individual questions rate one symptom on a 0-4 scale, with 4 meaning that the symptom is present all of the time and 0 meaning the symptom is present none of the time. The overall ODSI score is calculated by adding all of the values from the 12 questions, multiplying that value by 25, and dividing the resulting value by the number of questions answered. This results in an overall scale that ranges from 0-100, with 100 being severe dry eye symptoms and 0 being no dry eye symptoms.

2. Symptom Assessment in Dry Eye (SANDE) [4 week Time Point]

   A two-item survey used to assess the frequency and severity of dry eye disease. The SANDE score is calculated by taking the square root of the product of the frequency of symptoms score and the severity of symptoms score. The SANDE scale ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.

3. Corneal Fluorescein Staining (CFS) [4 week Time Point]

   Is used to assess the level of corneal epitheliopathy that is related to dry eye disease. The CFS scale ranges from 0 to 15 scale, with 0 representing the minimum level of corneal epitheliopathy and 15 representing the maximum level of epitheliopathy.

4. Tear Break Up Time (TBUT) [4 week Time Point]

   TBUT measures the amount of time, in seconds, a dry spot appears in the tear film after each blink. Values less than 10 seconds are considered abnormal.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 89 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts Eye and Ear Infirmary	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

• Joseph B. Ciolino, MD

Investigators

• Principal Investigator: Joseph B Ciolino, M. D., Massachusetts Eye and Ear Infirmary

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Joseph B. Ciolino, MD, Assistant Professor of Ophthalmology, Massachusetts Eye and Ear Infirmary
• ClinicalTrials.gov Identifier: NCT02256969
• Other Study ID Numbers: 14-059H
• First Posted: Oct 6, 2014
• Last Update Posted: Jun 19, 2017
• Last Verified: May 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Meibomian Gland Dysfunction; Sulfacetamide; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Mineral Oil; Prednisolone hemisuccinate; Prednisolone phosphate

Study Results

Participant Flow

Arm/Group Title	Meibomian Gland Probing Plus Lubricant	Sham Meibomian Gland Probing Plus Lubricant	Meibomian Gland Probing Plus Blephamide
Arm/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. Lubricant: GenTeal PM Night-Time Ointment, an ophthalmic lubricant that is 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.	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.	Meibomian Gland Probing: Stainless steel probes were used to probe the meibomian glands of upper lids of both eyes. 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.
Period Title: Overall Study
STARTED	15	15	15
COMPLETED	13	14	14
NOT COMPLETED	2	1	1

Baseline Characteristics

Arm/Group Title	Meibomian Gland Probing Plus Lubricant	Sham Meibomian Gland Probing Plus Lubricant	Meibomian Gland Probing Plus Blephamide	Total
Arm/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. Lubricant: GenTeal PM Night-Time Ointment, an ophthalmic lubricant that is 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.	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.	Meibomian Gland Probing: Stainless steel probes were used to probe the meibomian glands of upper lids of both eyes. 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.	Total of all reporting groups
Overall Participants	13	14	14	41
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59.6 (13.7)	63.9 (13.8)	59.8 (17.4)	61.1 (15.2)
Sex: Female, Male (Count of Participants)
Female	10 76.9%	10 71.4%	9 64.3%	29 70.7%
Male	3 23.1%	4 28.6%	5 35.7%	12 29.3%
Ocular Surface Disease Index (OSDI) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	45.3 (23.8)	49.1 (27.1)	49.1 (19.9)	47.9 (23.3)
Symptom Assessment in Dry Eye (SANDE) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	68.7 (15.4)	61.8 (22.5)	72.1 (14.1)	67.5 (17.8)
Corneal Fluorescein Staining (CFS) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	1.9 (1.6)	2.0 (2.0)	0.9 (1.0)	1.6 (1.6)
Tear Film Break-Up Time (TBUT) (Seconds) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Seconds]	2.9 (1.5)	3.0 (1.5)	2.3 (2.5)	3.0 (1.9)

Outcome Measures

1. Primary Outcome

Title	Ocular Surface Disease Index (OSDI)
Description	A 12-question survey used to measure the symptoms of dry eye disease. Each of the 12 individual questions rate one symptom on a 0-4 scale, with 4 meaning that the symptom is present all of the time and 0 meaning the symptom is present none of the time. The overall ODSI score is calculated by adding all of the values from the 12 questions, multiplying that value by 25, and dividing the resulting value by the number of questions answered. This results in an overall scale that ranges from 0-100, with 100 being severe dry eye symptoms and 0 being no dry eye symptoms.
Time Frame	4 week Time Point

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Meibomian Gland Probing Plus Lubricant	Sham Meibomian Gland Probing Plus Lubricant	Meibomian Gland Probing Plus Blephamide
Arm/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. Lubricant: GenTeal PM Night-Time Ointment, an ophthalmic lubricant that is 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.	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.	Meibomian Gland Probing: Stainless steel probes were used to probe the meibomian glands of upper lids of both eyes. 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.
Measure Participants	13	14	14
Mean (Standard Deviation) [units on a scale]	38.7 (20.3)	36.9 (28.2)	37.3 (21.0)

2. Primary Outcome

Title	Symptom Assessment in Dry Eye (SANDE)
Description	A two-item survey used to assess the frequency and severity of dry eye disease. The SANDE score is calculated by taking the square root of the product of the frequency of symptoms score and the severity of symptoms score. The SANDE scale ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.
Time Frame	4 week Time Point

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Meibomian Gland Probing Plus Lubricant	Sham Meibomian Gland Probing Plus Lubricant	Meibomian Gland Probing Plus Blephamide
Arm/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. Lubricant: GenTeal PM Night-Time Ointment, an ophthalmic lubricant that is 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.	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.	Meibomian Gland Probing: Stainless steel probes were used to probe the meibomian glands of upper lids of both eyes. 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.
Measure Participants	13	14	14
Mean (Standard Deviation) [units on a scale]	49.1 (22.5)	50.2 (27.6)	47.6 (25.5)

3. Primary Outcome

Title	Corneal Fluorescein Staining (CFS)
Description	Is used to assess the level of corneal epitheliopathy that is related to dry eye disease. The CFS scale ranges from 0 to 15 scale, with 0 representing the minimum level of corneal epitheliopathy and 15 representing the maximum level of epitheliopathy.
Time Frame	4 week Time Point

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Meibomian Gland Probing Plus Lubricant	Sham Meibomian Gland Probing Plus Lubricant	Meibomian Gland Probing Plus Blephamide
Arm/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. Lubricant: GenTeal PM Night-Time Ointment, an ophthalmic lubricant that is 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.	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.	Meibomian Gland Probing: Stainless steel probes were used to probe the meibomian glands of upper lids of both eyes. 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.
Measure Participants	13	14	14
Mean (Standard Deviation) [units on a scale]	2.4 (2.4)	2.0 (2.2)	1.4 (2.1)

4. Primary Outcome

Title	Tear Break Up Time (TBUT)
Description	TBUT measures the amount of time, in seconds, a dry spot appears in the tear film after each blink. Values less than 10 seconds are considered abnormal.
Time Frame	4 week Time Point

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Meibomian Gland Probing Plus Lubricant	Sham Meibomian Gland Probing Plus Lubricant	Meibomian Gland Probing Plus Blephamide
Arm/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. Lubricant: GenTeal PM Night-Time Ointment, an ophthalmic lubricant that is 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.	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.	Meibomian Gland Probing: Stainless steel probes were used to probe the meibomian glands of upper lids of both eyes. 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.
Measure Participants	13	14	14
Mean (Standard Deviation) [Seconds]	3.5 (2.4)	4.2 (3.0)	3.2 (2.9)

Adverse Events

Time Frame	4 weeks
Arm/Group Title	Meibomian Gland Probing Plus Lubricant		Sham Meibomian Gland Probing Plus Lubricant		Meibomian Gland Probing Plus Blephamide
Arm/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. Lubricant: GenTeal PM Night-Time Ointment, an ophthalmic lubricant that is 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.		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.		Meibomian Gland Probing: Stainless steel probes were used to probe the meibomian glands of upper lids of both eyes. 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.
All Cause Mortality
	Meibomian Gland Probing Plus Lubricant		Sham Meibomian Gland Probing Plus Lubricant		Meibomian Gland Probing Plus Blephamide
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/14 (0%)		0/14 (0%)
Serious Adverse Events
	Meibomian Gland Probing Plus Lubricant		Sham Meibomian Gland Probing Plus Lubricant		Meibomian Gland Probing Plus Blephamide
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/14 (0%)		0/14 (0%)
Other (Not Including Serious) Adverse Events
	Meibomian Gland Probing Plus Lubricant		Sham Meibomian Gland Probing Plus Lubricant		Meibomian Gland Probing Plus Blephamide
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/13 (7.7%)		3/14 (21.4%)		3/14 (21.4%)
Eye disorders
Eye Pain	1/13 (7.7%)		1/14 (7.1%)		2/14 (14.3%)
Redness	0/13 (0%)		2/14 (14.3%)		0/14 (0%)
Foreign Body Sensation	0/13 (0%)		0/14 (0%)		1/14 (7.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.