Clinical Trial: Treatment of Meibomian Gland Dysfunction and Evaporative Dry Eye

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: TearScience, Inc.

Current Primary Outcome:

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

Original Primary Outcome:

Current Secondary Outcome:

• 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.
• 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.
• 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.
• (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.
• 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.

Original Secondary Outcome:

Information By: TearScience, Inc.

Dates:
Date Received: January 27, 2009
Date Started: February 2009
Date Completion:
Last Updated: December 5, 2011
Last Verified: December 2011