Treatment of Meibomian Gland Dysfunction and Evaporative Dry Eye
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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.|