Back to resultsIntraductal Meibomian Gland Probing Trial (MGP)
Primary Purpose
Meibomian Gland Dysfunction
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Blephamide
GenTeal PM Night-Time
Meibomian Gland Probing
Sham Meibomian Gland Probing
Sponsored by
About this trial
This is an interventional treatment trial for Meibomian Gland Dysfunction
Eligibility 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
Sites / Locations
- Massachusetts Eye and Ear Infirmary
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Active Comparator
Arm Label
Meibomian Gland Probing plus lubricant
Sham Meibomian Gland Probing plus lubricant
Meibomian Gland Probing plus Blephamide
Arm 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.
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 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.
Outcomes
Primary Outcome Measures
Ocular Surface Disease Index (OSDI)
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.
Symptom Assessment in Dry Eye (SANDE)
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.
Corneal Fluorescein Staining (CFS)
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.
Tear Break Up Time (TBUT)
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02256969
Brief Title
Intraductal Meibomian Gland Probing Trial
Acronym
MGP
Official Title
Prospective, Randomized Clinical Trial of Meibomian Gland Probing Versus Sham Procedure for Refractory Meibomian Gland Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Joseph B. Ciolino, MD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meibomian Gland Dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Meibomian Gland Probing plus lubricant
Arm Type
Other
Arm 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.
Arm Title
Sham Meibomian Gland Probing plus lubricant
Arm Type
Other
Arm 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.
Arm Title
Meibomian Gland Probing plus Blephamide
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Blephamide
Other Intervention Name(s)
sulfacetamide sodium 10%/prednisolone acetate 0.2%, Allergan, Inc.
Intervention Type
Drug
Intervention Name(s)
GenTeal PM Night-Time
Other Intervention Name(s)
GenTeal PM Night-Time Ophthalmic Ointment Alcon
Intervention Type
Procedure
Intervention Name(s)
Meibomian Gland Probing
Intervention Description
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 Type
Procedure
Intervention Name(s)
Sham Meibomian Gland Probing
Intervention Description
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.
Primary Outcome Measure Information:
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
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
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
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph B Ciolino, M. D.
Organizational Affiliation
Massachusetts Eye and Ear Infirmary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts Eye and Ear Infirmary
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32882429
Citation
Kheirkhah A, Kobashi H, Girgis J, Jamali A, Ciolino JB, Hamrah P. A randomized, sham-controlled trial of intraductal meibomian gland probing with or without topical antibiotic/steroid for obstructive meibomian gland dysfunction. Ocul Surf. 2020 Oct;18(4):852-856. doi: 10.1016/j.jtos.2020.08.008. Epub 2020 Aug 31.
Results Reference
derived
Learn more about this trial
Intraductal Meibomian Gland Probing Trial
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