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NCT Number: NCT00832130

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.

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Key information

Conditions

Chalazion Cysts Dry Eye Syndromes Eye Diseases Eyelid Diseases Lacrimal Apparatus Diseases Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fayetteville, Arkansas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Manual Mini System

Device

In-office device treatment for meibomian gland dysfunction by a physician

iHeat Portable Warm Compress Therapy

Device

At-home daily warm compress therapy

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

TearScience, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jan 29, 2009
Registry last updated
Dec 12, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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