Treatment of Meibomian Gland Dysfunction and Evaporative Dry Eye

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
TearScience, Inc.
ClinicalTrials.gov Identifier:
NCT00832130
First received: January 27, 2009
Last updated: December 5, 2011
Last verified: December 2011
  Purpose

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 Intervention
Chalazion
Dry Eye Syndromes
Device: Manual Mini System
Device: iHeat Portable Warm Compress Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial for Treatment of Meibomian Gland Dysfunction and Evaporative Dry Eye

Resource links provided by NLM:


Further study details as provided by TearScience, Inc.:

Primary Outcome Measures:
  • Meibomian Gland Assessment (Total Meibomian Gland Secretion Score) [ Time Frame: Baseline, 2 Weeks and 4 Weeks ] [ Designated as safety issue: No ]
    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.

  • Incidence of Device-related Adverse Events [ Time Frame: Baseline through 4 Weeks ] [ Designated as safety issue: Yes ]
    Number of eyes for which a device-related AE occurred

  • Tear Break-up Time [ Time Frame: Baseline, 2 Weeks and 4 Weeks ] [ Designated as safety issue: No ]
    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:
  • Dry Eye Symptoms (Total SPEED Score) [ Time Frame: Baseline, 2 Weeks and 4 Weeks ] [ Designated as safety issue: No ]
    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.

  • Ocular Surface Staining (Corneal Staining Sum Score) [ Time Frame: Baseline through 4 Weeks ] [ Designated as safety issue: Yes ]
    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.

  • Intraocular Pressure [ Time Frame: Baseline through 4 Weeks ] [ Designated as safety issue: Yes ]
    Intraocular pressure (IOP) was evaluated by Goldmann applanation tonometry. Change in IOP from Baseline was assessed to confirm safety.

  • (LogMAR) Best Spectacle Corrected Visual Acuity [ Time Frame: Baseline, 2 Weeks and 4 Weeks ] [ Designated as safety issue: Yes ]
    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.

  • Discomfort Evaluation (Discomfort/Pain Score) [ Time Frame: Treatment and 1 Day ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 139
Study Start Date: February 2009
Study Completion Date: August 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT00832130

Locations
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
Study Director: Christy Stevens, OD TearScience, Inc.
  More Information

No publications provided

Responsible Party: TearScience, Inc.
ClinicalTrials.gov Identifier: NCT00832130     History of Changes
Other Study ID Numbers: LF001
Study First Received: January 27, 2009
Results First Received: September 19, 2011
Last Updated: December 5, 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 July 28, 2014