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Treatment of Meibomian Gland Dysfunction and Evaporative Dry Eye

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ClinicalTrials.gov Identifier: NCT00832130
Recruitment Status : Completed
First Posted : January 29, 2009
Results First Posted : December 6, 2011
Last Update Posted : December 12, 2011
Sponsor:
Information provided by (Responsible Party):
TearScience, Inc.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chalazion Dry Eye Syndromes Device: Manual Mini System Device: iHeat Portable Warm Compress Therapy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 139 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial for Treatment of Meibomian Gland Dysfunction and Evaporative Dry Eye
Study Start Date : February 2009
Actual Primary Completion Date : June 2009
Actual Study Completion Date : August 2009
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. Incidence of Device-related Adverse Events [ Time Frame: Baseline through 4 Weeks ]
    Number of eyes for which a device-related AE occurred

  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. (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.

  5. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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

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
Contacts and Locations
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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): NCT00832130


Locations
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United States, Arkansas
Fayetteville, Arkansas, United States
United States, Georgia
Morrow, Georgia, United States
United States, Illinois
Highland Park, Illinois, United States
United States, Kentucky
Edgewood, Kentucky, United States
Lexington, Kentucky, United States
United States, Massachusetts
Winchester, Massachusetts, United States
United States, Michigan
Jackson, Michigan, United States
United States, Minnesota
Bloomington, Minnesota, United States
Stillwater, Minnesota, United States
United States, North Carolina
Charlotte, North Carolina, United States
United States, Pennsylvania
Lancaster, Pennsylvania, United States
Sponsors and Collaborators
TearScience, Inc.
Investigators
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Study Director: Christy Stevens, OD TearScience, Inc.
More Information
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Responsible Party: TearScience, Inc.
ClinicalTrials.gov Identifier: NCT00832130    
Other Study ID Numbers: LF001
First Posted: January 29, 2009    Key Record Dates
Results First Posted: December 6, 2011
Last Update Posted: December 12, 2011
Last Verified: December 2011
Additional relevant MeSH terms:
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Chalazion
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Meibomian Gland Dysfunction
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
 Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Eyelid Diseases
Cysts
Neoplasms