Intraductal Meibomian Gland Probing Trial (MGP)

23 mars 2015

Intraductal Meibomian Gland Probing Trial (MGP)

This study is currently recruiting participants. (see Contacts and Locations)

Verified October 2014 by Massachusetts Eye and Ear Infirmary

Sponsor:

Information provided by (Responsible Party):

Pedram Hamrah, MD, Massachusetts Eye & Ear Infirmary

ClinicalTrials.gov Identifier:

NCT02256969

First received: August 13, 2014

Last updated: October 3, 2014

Last verified: October 2014

History of Changes

Purpose

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	Intervention	Phase
Meibomian Gland Dysfunction	Drug: Blephamide Drug: GenTeal PM Night-Time Procedure: Meibomian Gland Probing Procedure: Sham Meibomian Gland Probing	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Prospective, Randomized Clinical Trial of Meibomian Gland Probing Versus Sham Procedure for Refractory Meibomian Gland Dysfunction

Resource links provided by NLM:

Drug Information available for: Prednisolone Prednisolone acetate Sulfacetamide Hydroxypropyl methylcellulose

U.S. FDA Resources

Further study details as provided by Massachusetts Eye and Ear Infirmary:

Primary Outcome Measures:

Symptoms [ Time Frame: 1 Month ] [ Designated as safety issue: No ]
Symptoms will be assessed using the Ocular Surface Disease Index (OSDI) questionnaire and the Symptom Assessment iN Dry Eye (SANDE) questionnaire
Tear Break Up Time (TBUT) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
TBUT will be assessed using fluorescein staining

Estimated Enrollment:	45
Study Start Date:	October 2014
Estimated Study Completion Date:	May 2015
Estimated Primary Completion Date:	May 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Meibomian Gland Probing plus placebo Meibomian Gland Probing: After obtaining adequate anesthesia using 3.5% topical lidocaine hydrochloride jelly and if necessary 2% injected lidocaine (Akron), the solid stainless steel probes (Maskin® Meibomian Gland Intraductal Probes, Rhein Medical Inc.) will be used to probe all the meibomian glands of upper lids of both eyes at the slit lamp. All patients will initially be probed with a 1-mm probe followed by a 2-mm probe for all glands. Placebo: GenTeal PM Night-Time Ointment (Alcon) is a sterile ophthalmic lubricant that is commonly used to relieve symptoms in patients with dry eye disease. Its active ingredients are mineral oil (3%) and white petrolatum (94%). The ointment will be 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 Name: GenTeal PM Night-Time Ophthalmic Ointment Alcon Procedure: Meibomian Gland Probing For anesthesia, topical 3.5% lidocaine hydrochloride jelly (Akron) will be applied directly with sterile cotton-tipped applicator to the lid margin for 3 times every 10 minutes before the procedure. If necessary, 2% lidocaine will be 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.) will be used to probe all the meibomian glands of upper lids of both eyes at the slit lamp. All patients will initially be probed with a 1-mm probe followed by a 2-mm probe for all glands.
Sham Meibomian Gland Probing plus placebo Both a sham procedure and placebo medication will be used. Sham Meibomian Gland Probing: After obtaining adequate anesthesia using 3.5% topical lidocaine hydrochloride jelly and if necessary 2% injected lidocaine (Akron), the patient's lid margin will be touched with the probes without actual probing of the meibomian gland orifices. Placebo: GenTeal PM Night-Time Ointment (Alcon) is a sterile ophthalmic lubricant that is commonly used to relieve symptoms in patients with dry eye disease. Its active ingredients are mineral oil (3%) and white petrolatum (94%). The ointment will be 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 Name: GenTeal PM Night-Time Ophthalmic Ointment Alcon Procedure: Sham Meibomian Gland Probing For anesthesia, topical 3.5% lidocaine hydrochloride jelly (Akron) will be applied directly with sterile cotton-tipped applicator to the lid margin for 3 times every 10 minutes before the procedure. If necessary, 2% lidocaine will be injected into the lid margin during the procedure to provide additional comfort. The patient's lid margin will be touched with the probes without actual probing of the meibomian gland orifices.
Active Comparator: Meibomian Gland Probing plus Blephamide Meibomian Gland Probing: Solid stainless steel probes (Maskin® Meibomian GlandIntraductal Probes, Rhein Medical Inc.) will be used to probe all the meibomian glands of upper lids of both eyes at the slit lamp after obtaining adequate anesthesia. All patients will initially be probed with a 1-mm probe followed by a 2-mm probe for all glands. Blephamide: (sulfacetamide sodium 10%/ prednisolone acetate 0.2% ophthalmicointment, Allergan) is an FDA approved combination of an antibiotic (sulfacetamide) and an anti-inflammatory agent (prednisolone acetate) commonly used for the treatment of various ocular conditions in which both infection and inflammation play a role. It is preserved with phenylmercuric acetate (0.008%) and contains inactive ingredients of mineral oil, petrolatum and lanolin alcohol and white petrolatum. It will be 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 Name: sulfacetamide sodium 10%/prednisolone acetate 0.2%, Allergan, Inc. Procedure: Meibomian Gland Probing For anesthesia, topical 3.5% lidocaine hydrochloride jelly (Akron) will be applied directly with sterile cotton-tipped applicator to the lid margin for 3 times every 10 minutes before the procedure. If necessary, 2% lidocaine will be 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.) will be used to probe all the meibomian glands of upper lids of both eyes at the slit lamp. All patients will initially be probed with a 1-mm probe followed by a 2-mm probe for all glands.

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.

Eligibility

Ages Eligible for Study:	18 Years to 89 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02256969

Contacts

Contact: Ophthalmology Clinical Research Office	617-573-6060	ophthalmologyclinicalresearch@meei.harvard.edu

Locations

United States, Massachusetts
Massachusetts Eye and Ear Infirmary	Recruiting
Boston, Massachusetts, United States, 02114
Contact: Sally Kiebdaj 617-573-3313 Sally_Kiebdaj@MEEI.HARVARD.EDU
Principal Investigator: Pedram Hamrah, M. D.

Sponsors and Collaborators

Pedram Hamrah, MD

Investigators

Principal Investigator:	Pedram Hamrah, M. D.	Massachusetts Eye and Ear Infirmary

More Information

No publications provided

Responsible Party:	Pedram Hamrah, MD, MD, Massachusetts Eye & Ear Infirmary
ClinicalTrials.gov Identifier:	NCT02256969 History of Changes
Other Study ID Numbers:	14-059H
Study First Received:	August 13, 2014
Last Updated:	October 3, 2014
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Lidocaine Prednisolone acetate Anesthetics Anesthetics, Local Anti-Arrhythmia Agents Anti-Inflammatory Agents Cardiovascular Agents Central Nervous System Agents Central Nervous System Depressants	Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Sensory System Agents Sodium Channel Blockers Therapeutic Uses Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on March 22, 2015

TO TOP