Evaluation of Screening Methods for Treatment of Meibomian Gland Dysfunction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
TearScience, Inc.
ClinicalTrials.gov Identifier:
NCT01202747
First received: September 14, 2010
Last updated: November 1, 2011
Last verified: November 2011
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study for Evaluation of LipiFlow Screening Methods

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: TearScience, Inc.
ClinicalTrials.gov Identifier: NCT01202747     History of Changes
Other Study ID Numbers: LF002
Study First Received: September 14, 2010
Results First Received: September 16, 2011
Last Updated: November 1, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 20, 2014