Treatment of Meibomian Gland Dysfunction and Evaporative Dry Eye
|ClinicalTrials.gov Identifier: NCT00832130|
Recruitment Status : Completed
First Posted : January 29, 2009
Results First Posted : December 6, 2011
Last Update Posted : December 12, 2011
|Condition or disease||Intervention/treatment||Phase|
|Chalazion Dry Eye Syndromes||Device: Manual Mini System Device: iHeat Portable Warm Compress Therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||139 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Clinical Trial for Treatment of Meibomian Gland Dysfunction and Evaporative Dry Eye|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||August 2009|
Experimental: Manual Mini System
Treatment with experimental Manual Mini System
Device: Manual Mini System
In-office device treatment for meibomian gland dysfunction by a physician
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
Device: Manual Mini System
In-office device treatment for meibomian gland dysfunction by a physicianDevice: iHeat Portable Warm Compress Therapy
At-home daily warm compress therapy
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00832130
|United States, Arkansas|
|Fayetteville, Arkansas, United States|
|United States, Georgia|
|Morrow, Georgia, United States|
|United States, Illinois|
|Highland Park, Illinois, United States|
|United States, Kentucky|
|Edgewood, Kentucky, United States|
|Lexington, Kentucky, United States|
|United States, Massachusetts|
|Winchester, Massachusetts, United States|
|United States, Michigan|
|Jackson, Michigan, United States|
|United States, Minnesota|
|Bloomington, Minnesota, United States|
|Stillwater, Minnesota, United States|
|United States, North Carolina|
|Charlotte, North Carolina, United States|
|United States, Pennsylvania|
|Lancaster, Pennsylvania, United States|
|Study Director:||Christy Stevens, OD||TearScience, Inc.|