Treatment of Meibomian Gland Dysfunction and Evaporative Dry Eye

December 5, 2011 updated by: TearScience, Inc.

Randomized Clinical Trial for Treatment of Meibomian Gland Dysfunction and Evaporative Dry Eye

The objective of this study is to evaluate the clinical utility, safety and effectiveness of the Manual Mini System compared to standardized warm compress therapy for application of controlled, localized heat 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

139

Phase

  • Not Applicable

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
    • Arkansas
      • Fayetteville, Arkansas, United States
    • Georgia
      • Morrow, Georgia, United States
    • Illinois
      • Highland Park, Illinois, United States
    • Kentucky
      • Edgewood, Kentucky, United States
      • Lexington, Kentucky, United States
    • Massachusetts
      • Winchester, Massachusetts, United States
    • Michigan
      • Jackson, Michigan, United States
    • Minnesota
      • Bloomington, Minnesota, United States
      • Stillwater, Minnesota, United States
    • North Carolina
      • Charlotte, North Carolina, United States
    • Pennsylvania
      • Lancaster, Pennsylvania, United States

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • At least 18 years of age.
  • Meibomian gland obstruction
  • Dry eye symptoms
  • Willingness to comply with study procedures and return for all visits

Exclusion Criteria:

  • Ocular surgery, injury, or 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
  • Macular disease
  • Systemic disease condition or medication that causes 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

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: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Manual Mini System
Treatment with experimental Manual Mini System
Device: Manual Mini System
In-office device treatment for meibomian gland dysfunction by a physician
ACTIVE_COMPARATOR: Warm Compress Therapy
Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
Device: Manual Mini System
In-office device treatment for meibomian gland dysfunction by a physician
Device: iHeat Portable Warm Compress Therapy
At-home daily warm compress therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Meibomian Gland Assessment (Total Meibomian Gland Secretion Score)
Time Frame: Baseline, 2 Weeks and 4 Weeks
Evaluation of secretion characteristics from the gland orifices along the lower eyelid. Assessment was based on the grading scale: 3 (clear liquid secretion), 2 (cloudy liquid secretion), 1 (inspissated), 0 (no secretion). The total meibomian gland secretion score was the sum of the grades for all 15 glands with a range of 0 to 45.
Baseline, 2 Weeks and 4 Weeks
Incidence of Device-related Adverse Events
Time Frame: Baseline through 4 Weeks
Number of eyes for which a device-related AE occurred
Baseline through 4 Weeks
Tear Break-up Time
Time Frame: Baseline, 2 Weeks and 4 Weeks
Tear break-up time measured under a slit lamp biomicroscope following instillation of fluorescein dye in the eye. Time was measured in seconds with a maximum of 20. Higher tear break-up time indicates better tear film stability.
Baseline, 2 Weeks and 4 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dry Eye Symptoms (Total SPEED Score)
Time Frame: Baseline, 2 Weeks and 4 Weeks
Standard Patient Evaluation of Eye Dryness questionnaire. Assessment of subjects' frequency and severity of dry eye symptoms. The total score was calculated as the sum scores for all symptoms over a range of 0 to 28. A lower total SPEED score represents less frequent and/or less severe symptoms.
Baseline, 2 Weeks and 4 Weeks
Ocular Surface Staining (Corneal Staining Sum Score)
Time Frame: Baseline through 4 Weeks
Corneal staining score in five corneal regions, evaluated on a scale from 0 (none), 1 (mild), 2 (moderate) to 3 (severe). The sum of the five corneal staining scores was on a scale from 0 to 15. A lower grade indicates less corneal surface desiccation.
Baseline through 4 Weeks
Intraocular Pressure
Time Frame: Baseline through 4 Weeks
Intraocular pressure (IOP) was evaluated by Goldmann applanation tonometry. Change in IOP from Baseline was assessed to confirm safety.
Baseline through 4 Weeks
(LogMAR) Best Spectacle Corrected Visual Acuity
Time Frame: Baseline, 2 Weeks and 4 Weeks
Measurement of BSCVA at a distance using a logMAR chart under standard illumination. The logMAR ranged from -0.30 to 1.0. A lower logMAR value is a better visual acuity.
Baseline, 2 Weeks and 4 Weeks
Discomfort Evaluation (Discomfort/Pain Score)
Time Frame: Treatment and 1 Day
Subject-reported numeric score reflecting low or high intensity. Scores ranged from 0 to 10, with 0 being no discomfort or pain and 10 being intolerable pain.
Treatment and 1 Day

Collaborators and Investigators

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

Sponsor

TearScience, Inc.

Investigators

  • Study Director: Christy Stevens, OD, TearScience, Inc.

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

February 1, 2009

Primary Completion (ACTUAL)

June 1, 2009

Study Completion (ACTUAL)

August 1, 2009

Study Registration Dates

First Submitted

January 27, 2009

First Submitted That Met QC Criteria

January 28, 2009

First Posted (ESTIMATE)

January 29, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

December 12, 2011

Last Update Submitted That Met QC Criteria

December 5, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LF001

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.

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