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Completed

NCT Number: NCT01202747

Evaluation of Screening Methods for Treatment of Meibomian Gland Dysfunction

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.

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Key information

Conditions

Chalazion Cysts Dry Eye Syndromes Eye Diseases Eyelid Diseases Lacrimal Apparatus Diseases Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Hoffman Estates, Illinois, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LipiFlow System

Device

In-office treatment for meibomian gland dysfunction

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

TearScience, Inc.

Industry

Registry information

Official study title

Pilot Study for Evaluation of LipiFlow Screening Methods

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 16, 2010
Registry last updated
Dec 6, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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