An interventional study of Manual Mini System and iHeat Portable Warm Compress Therapy in Chalazion and Dry Eye Syndromes, sponsored by TearScience, Inc.. Completed at 11 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-12-12.
Sponsored by TearScience, Inc. · Not applicable, Interventional, and Treatment
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.
1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.
This study's enrollment of 139 is above the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →TearScience, Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Treatment with experimental Manual Mini System
Device: Manual Mini System
Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
Device: Manual Mini System · Device: iHeat Portable Warm Compress Therapy
In-office device treatment for meibomian gland dysfunction by a physician
At-home daily warm compress therapy
Meibomian Gland Assessment (Total Meibomian Gland Secretion Score)
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.
Time frame: Baseline, 2 Weeks and 4 Weeks
Incidence of Device-related Adverse Events
Number of eyes for which a device-related AE occurred
Time frame: Baseline through 4 Weeks
Tear Break-up Time
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.
Time frame: Baseline, 2 Weeks and 4 Weeks
Dry Eye Symptoms (Total SPEED Score)
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.
Time frame: Baseline, 2 Weeks and 4 Weeks
Ocular Surface Staining (Corneal Staining Sum Score)
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.
Time frame: Baseline through 4 Weeks
Intraocular Pressure
Intraocular pressure (IOP) was evaluated by Goldmann applanation tonometry. Change in IOP from Baseline was assessed to confirm safety.
Time frame: Baseline through 4 Weeks
(LogMAR) Best Spectacle Corrected Visual Acuity
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.
Time frame: Baseline, 2 Weeks and 4 Weeks
Discomfort Evaluation (Discomfort/Pain Score)
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.
Time frame: Treatment and 1 Day
A total of 139 subjects (278 eyes) were enrolled at nine clinical sites between 03/04/2009 and 05/14/2009.
| Milestone | Manual Mini System | Warm Compress Therapy |
|---|---|---|
| Started | 69 | 70 |
| Completed | 69 | 70 |
| Not completed | 0 | 0 |
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.
| Scores on a scale | Manual Mini System | Warm Compress Therapy |
|---|---|---|
| Baseline (N=130, 136) | 6.3 ± 3.5 | 5.6 ± 3.9 |
| 2 Weeks (N=130, 136) | 14.3 ± 8.7 | 6.1 ± 5.6 |
| 4 Weeks (N=128, 132) | 16.7 ± 8.7 | 11.7 ± 7.3 |
Number of eyes for which a device-related AE occurred
| Events | Manual Mini System | Warm Compress Therapy |
|---|---|---|
| Incidence of Device-related Adverse Events | 4 | 2 |
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.
| Scores on a scale | Manual Mini System | Warm Compress Therapy |
|---|---|---|
| Baseline (N=130, 136) | 14.3 ± 4.8 | 14.8 ± 4.8 |
| 2 Weeks (N=130, 136) | 8.1 ± 5.5 | 11.2 ± 5.4 |
| 4 Weeks (N=128, 132) | 7.6 ± 5.8 | 7.9 ± 5.6 |
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.
| Scores on a scale | Manual Mini System | Warm Compress Therapy |
|---|---|---|
| Baseline | 2.2 ± 2.2 | 2.0 ± 2.0 |
| 2 Weeks | 1.9 ± 2.0 | 2.0 ± 2.2 |
| 4 Weeks | 1.5 ± 1.7 | 1.6 ± 1.9 |
Intraocular pressure (IOP) was evaluated by Goldmann applanation tonometry. Change in IOP from Baseline was assessed to confirm safety.
| mmHg | Manual Mini System | Warm Compress Therapy |
|---|---|---|
| Baseline (N=138, 140) | 13.3 ± 3.3 | 14.0 ± 2.8 |
| Immediate Post-Treatment (N=138, 140) | 14.3 ± 3.3 | 15.0 ± 3.3 |
| 4 Weeks (138, 136) | 12.5 ± 2.9 | 13.1 ± 2.5 |
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.
| LogMAR | Manual Mini System | Warm Compress Therapy |
|---|---|---|
| Baseline (N=138, 140) | 0.00 ± 0.12 | 0.01 ± 0.12 |
| 2 Weeks (N=136, 136) | -0.02 ± 0.13 | 0.02 ± 0.13 |
| 4 Weeks (N=138, 136) | -0.02 ± 0.12 | -0.01 ± 0.13 |
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.
| Scores on a scale | Manual Mini System | Warm Compress Therapy |
|---|---|---|
| During Treatment (N=138, 140) | 1.4 ± 1.4 | 0.1 ± 0.7 |
| Immediate Post-Treatment (N=138, 140) | 0.2 ± 0.6 | 0.0 ± 0.2 |
| 1 Day (N=138) | 0.2 ± 0.7 | NA ± NA |
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.
| Seconds | Manual Mini System | Warm Compress Therapy |
|---|---|---|
| Baseline (N=130, 136) | 5.5 ± 2.9 | 5.4 ± 3.5 |
| 2 Weeks (N=130, 136) | 6.9 ± 5.0 | 5.3 ± 3.5 |
| 4 Weeks (N=128, 132) | 7.4 ± 5.5 | 6.3 ± 4.7 |
Collected over The presence of adverse events was evaluated at all study visits, including unscheduled visits.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Manual Mini System | — | 1/69 (1.4%) | 0/69 (0%) |
| Warm Compress Therapy | — | 1/70 (1.4%) | 0/70 (0%) |
| Event | Manual Mini System | Warm Compress Therapy |
|---|---|---|
| Elective Knee SurgeryMusculoskeletal and connective tissue disorders | 1/69 | 0/70 |
| StrokeVascular disorders | 0/69 | 1/70 |
| Age Continuous(Years) | Manual Mini System | Warm Compress Therapy | Total |
|---|---|---|---|
| Mean | 52.4 ± 14.6 | 54.4 ± 16.4 | 53.4 ± 15.5 |
| Sex: Female, Male(Participants) | Manual Mini System | Warm Compress Therapy | Total |
|---|---|---|---|
| Female | 44 | 53 | 97 |
| Male | 25 | 17 | 42 |
This study is completed, as verified in Dec 2011. You cannot join it, but the record below documents what was studied.
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Chalazion
TearScience, Inc.