Treatment of Meibomian Gland Dysfunction and Evaporative Dry Eye

• 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.

• 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.

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.

• 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

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