Treatment of Meibomian Gland Dysfunction and Evaporative Dry Eye

Not Applicable

Completed

• Conditions: Chalazion; Dry Eye Syndromes
• Interventions: Device: Manual Mini System; Device: iHeat Portable Warm Compress Therapy

• Registration Number: NCT00832130
• Lead Sponsor: TearScience, Inc.

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 Description

Not available

Study Timeline

• Study First Submitted: 2009-01-27
• Study First Submitted QC: 2009-01-28
• Study First Posted: 2009-01-29
• Study Start: 2009-02
• Primary Completion: 2009-06
• Study Completion: 2009-08
• Results First Submitted: 2011-09-19
• Results First Submitted QC: 2011-11-01
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-05
• Results First Posted: 2011-12-06
• Last Update Posted: 2011-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 139

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Manual Mini System	Manual Mini System	Treatment with experimental Manual Mini System
Warm Compress Therapy	Manual Mini System	Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
Warm Compress Therapy	iHeat Portable Warm Compress Therapy	Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase

Primary Outcome Measures

Name	Time	Method
Meibomian Gland Assessment (Total Meibomian Gland Secretion Score)	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	Baseline through 4 Weeks	Number of eyes for which a device-related AE occurred
Tear Break-up Time	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 Outcome Measures

Name	Time	Method
Dry Eye Symptoms (Total SPEED Score)	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)	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	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	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)	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.