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

January 27, 2009
December 5, 2011
February 2009
June 2009   (final data collection date for primary outcome measure)
  • 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.
Not Provided
Complete list of historical versions of study NCT00832130 on ClinicalTrials.gov Archive Site
  • 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.
Not Provided
Not Provided
Not Provided
 
Treatment of Meibomian Gland Dysfunction and Evaporative Dry Eye
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Chalazion
  • Dry Eye Syndromes
  • 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
  • Experimental: Manual Mini System
    Treatment with experimental Manual Mini System
    Intervention: Device: Manual Mini System
  • 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
    Interventions:
    • Device: Manual Mini System
    • Device: iHeat Portable Warm Compress Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
139
August 2009
June 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00832130
LF001
No
TearScience, Inc.
TearScience, Inc.
Not Provided
Study Director: Christy Stevens, OD TearScience, Inc.
TearScience, Inc.
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP