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Evaluation of Screening Methods for Treatment of Meibomian Gland Dysfunction

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01202747
First Posted: September 16, 2010
Last Update Posted: December 6, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
TearScience, Inc.
  Purpose
The objective is to evaluate the feasibility of using additional screening methods to optimize effectiveness outcomes with the LipiFlow System for application of heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye, and chalazia. The screening methods include diagnostic expression of the meibomian glands and interferometry assessment of the tear film.

Condition Intervention Phase
Chalazion Dry Eye Syndromes Device: LipiFlow System Phase 2 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study for Evaluation of LipiFlow Screening Methods

Further study details as provided by TearScience, Inc.:

Primary Outcome Measures:
  • Association Between Screening Methods (Meibomian Gland Expression) and Treatment Effectiveness Outcomes (Total Meibomian Gland Score) [ Time Frame: Baseline and 4 Weeks ]

    Analysis of association between Baseline Meibomian Gland Expression Score and Total Meibomian Gland Score at 4 Weeks. Success was defined by demonstration of a statistically significant (p<0.05) association between the screening method and outcome.

    Meibomian gland expression sum scores range from 0 to 60 with a higher score reflecting less meibomian gland dysfunction. Total meibomian gland scores range from 0 to 45 with a higher score reflecting less meibomian gland dysfunction.



Enrollment: 50
Study Start Date: September 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LipiFlow Treatment
Treatment with LipiFlow device
Device: LipiFlow System
In-office treatment for meibomian gland dysfunction

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meibomian gland dysfunction
  • Dry Eye symptoms

Exclusion Criteria:

  • Ocular surgery, ocular injury or ocular Herpes infection within past 3 months
  • Active ocular infection
  • Active ocular inflammation or recurrent inflammation within past 3 months
  • Moderate to severe allergic conjunctivitis
  • Severe eyelid inflammation
  • Eyelid abnormalities that affect lid function
  • Ocular surface abnormalities that may compromise corneal integrity
  • Systemic disease conditions or medications that cause dry eye
  • Use of other treatments for meibomian gland dysfunction or dry eye
  • Pregnant or nursing women
  • Participation in another ophthalmic clinical trial within past 30 days
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01202747


Locations
United States, Illinois
Hoffman Estates, Illinois, United States
United States, Massachusetts
Boston, Massachusetts, United States
Winchester, Massachusetts, United States
Sponsors and Collaborators
TearScience, Inc.
Investigators
Study Director: Christy Stevens, OD TearScience
  More Information

Responsible Party: TearScience, Inc.
ClinicalTrials.gov Identifier: NCT01202747     History of Changes
Other Study ID Numbers: LF002
First Submitted: September 14, 2010
First Posted: September 16, 2010
Results First Submitted: September 16, 2011
Results First Posted: December 6, 2011
Last Update Posted: December 6, 2011
Last Verified: November 2011

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Chalazion
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Cysts
Neoplasms
Eyelid Diseases