Intraductal Meibomian Gland Probing Trial (MGP)

May 25, 2017 updated by: Joseph B. Ciolino, MD

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts Eye and Ear Infirmary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 87 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.
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.
Drug: Blephamide
Other Names:
  • sulfacetamide sodium 10%/prednisolone acetate 0.2%, Allergan, Inc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ocular Surface Disease Index (OSDI)
Time Frame: 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.
4 week Time Point
Symptom Assessment in Dry Eye (SANDE)
Time Frame: 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.
4 week Time Point
Corneal Fluorescein Staining (CFS)
Time Frame: 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 week Time Point
Tear Break Up Time (TBUT)
Time Frame: 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.
4 week Time Point

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Joseph B. Ciolino, MD

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

August 13, 2014

First Submitted That Met QC Criteria

October 3, 2014

First Posted (Estimate)

October 6, 2014

Study Record Updates

Last Update Posted (Actual)

June 19, 2017

Last Update Submitted That Met QC Criteria

May 25, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-059H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Meibomian Gland Dysfunction

Clinical Trials on GenTeal PM Night-Time

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Qatar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe