Chalazion, Dry Eye Syndromes
Conditions
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.
Interventions
DEVICEManual Mini System
In-office device treatment for meibomian gland dysfunction by a physician
DEVICEiHeat Portable Warm Compress Therapy
At-home daily warm compress therapy
Sponsors
TearScience, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Participant flow
Recruitment details
A total of 139 subjects (278 eyes) were enrolled at nine clinical sites between 03/04/2009 and 05/14/2009.
Pre-assignment details
At the 2 Week visit, Control subjects stopped the warm compress therapy and received a single Manual Mini (LipiFlow) crossover treatment.
Participants by arm
| Arm | Count |
|---|---|
| Manual Mini System Treatment with experimental Manual Mini System | 69 |
| Warm Compress Therapy Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase | 70 |
| Total | 139 |
Baseline characteristics
| Characteristic | Manual Mini System | Warm Compress Therapy | Total |
|---|---|---|---|
| Age Continuous | 52.4 Years STANDARD_DEVIATION 14.6 | 54.4 Years STANDARD_DEVIATION 16.4 | 53.4 Years STANDARD_DEVIATION 15.5 |
| Sex: Female, Male Female | 44 Participants | 53 Participants | 97 Participants |
| Sex: Female, Male Male | 25 Participants | 17 Participants | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 69 | 0 / 70 |
| serious Total, serious adverse events | 1 / 69 | 1 / 70 |
Outcome results
Primary
Incidence of Device-related Adverse Events
Number of eyes for which a device-related AE occurred
Time frame: Baseline through 4 Weeks
Population: Results presented are of the Intent to Treat Population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Manual Mini System | Incidence of Device-related Adverse Events | 4 Events |
| Warm Compress Therapy | Incidence of Device-related Adverse Events | 2 Events |
Primary
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
Population: Results presented are for the Per Protocol population. 4 Weeks data for the Warm Compress Control group are after crossover.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Manual Mini System | Meibomian Gland Assessment (Total Meibomian Gland Secretion Score) | Baseline (N=130, 136) | 6.3 Scores on a scale | Standard Deviation 3.5 |
| Manual Mini System | Meibomian Gland Assessment (Total Meibomian Gland Secretion Score) | 2 Weeks (N=130, 136) | 14.3 Scores on a scale | Standard Deviation 8.7 |
| Manual Mini System | Meibomian Gland Assessment (Total Meibomian Gland Secretion Score) | 4 Weeks (N=128, 132) | 16.7 Scores on a scale | Standard Deviation 8.7 |
| Warm Compress Therapy | Meibomian Gland Assessment (Total Meibomian Gland Secretion Score) | Baseline (N=130, 136) | 5.6 Scores on a scale | Standard Deviation 3.9 |
| Warm Compress Therapy | Meibomian Gland Assessment (Total Meibomian Gland Secretion Score) | 2 Weeks (N=130, 136) | 6.1 Scores on a scale | Standard Deviation 5.6 |
| Warm Compress Therapy | Meibomian Gland Assessment (Total Meibomian Gland Secretion Score) | 4 Weeks (N=128, 132) | 11.7 Scores on a scale | Standard Deviation 7.3 |
Primary
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
Population: Results presented are for the Per Protocol population. 4 Weeks data for the Warm Compress Control group are after crossover.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Manual Mini System | Tear Break-up Time | Baseline (N=130, 136) | 5.5 Seconds | Standard Deviation 2.9 |
| Manual Mini System | Tear Break-up Time | 2 Weeks (N=130, 136) | 6.9 Seconds | Standard Deviation 5 |
| Manual Mini System | Tear Break-up Time | 4 Weeks (N=128, 132) | 7.4 Seconds | Standard Deviation 5.5 |
| Warm Compress Therapy | Tear Break-up Time | Baseline (N=130, 136) | 5.4 Seconds | Standard Deviation 3.5 |
| Warm Compress Therapy | Tear Break-up Time | 2 Weeks (N=130, 136) | 5.3 Seconds | Standard Deviation 3.5 |
| Warm Compress Therapy | Tear Break-up Time | 4 Weeks (N=128, 132) | 6.3 Seconds | Standard Deviation 4.7 |
Secondary
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
Population: Results presented are of the Intent to Treat population. Only the Manual Mini group underwent a 1 day assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Manual Mini System | Discomfort Evaluation (Discomfort/Pain Score) | During Treatment (N=138, 140) | 1.4 Scores on a scale | Standard Deviation 1.4 |
| Manual Mini System | Discomfort Evaluation (Discomfort/Pain Score) | Immediate Post-Treatment (N=138, 140) | 0.2 Scores on a scale | Standard Deviation 0.6 |
| Manual Mini System | Discomfort Evaluation (Discomfort/Pain Score) | 1 Day (N=138) | 0.2 Scores on a scale | Standard Deviation 0.7 |
| Warm Compress Therapy | Discomfort Evaluation (Discomfort/Pain Score) | During Treatment (N=138, 140) | 0.1 Scores on a scale | Standard Deviation 0.7 |
| Warm Compress Therapy | Discomfort Evaluation (Discomfort/Pain Score) | Immediate Post-Treatment (N=138, 140) | 0.0 Scores on a scale | Standard Deviation 0.2 |
| Warm Compress Therapy | Discomfort Evaluation (Discomfort/Pain Score) | 1 Day (N=138) | NA Scores on a scale | — |
Secondary
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
Population: Results presented are for the Per Protocol population. 4 Weeks data for the Warm Compress Control group are after crossover.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Manual Mini System | Dry Eye Symptoms (Total SPEED Score) | Baseline (N=130, 136) | 14.3 Scores on a scale | Standard Deviation 4.8 |
| Manual Mini System | Dry Eye Symptoms (Total SPEED Score) | 2 Weeks (N=130, 136) | 8.1 Scores on a scale | Standard Deviation 5.5 |
| Manual Mini System | Dry Eye Symptoms (Total SPEED Score) | 4 Weeks (N=128, 132) | 7.6 Scores on a scale | Standard Deviation 5.8 |
| Warm Compress Therapy | Dry Eye Symptoms (Total SPEED Score) | Baseline (N=130, 136) | 14.8 Scores on a scale | Standard Deviation 4.8 |
| Warm Compress Therapy | Dry Eye Symptoms (Total SPEED Score) | 2 Weeks (N=130, 136) | 11.2 Scores on a scale | Standard Deviation 5.4 |
| Warm Compress Therapy | Dry Eye Symptoms (Total SPEED Score) | 4 Weeks (N=128, 132) | 7.9 Scores on a scale | Standard Deviation 5.6 |
Secondary
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
Population: Results presented are of the Intent to Treat population. Post-Treatment results for the Control group are before crossover treatment. 4 Weeks results for the Control group are after crossover treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Manual Mini System | Intraocular Pressure | Baseline (N=138, 140) | 13.3 mmHg | Standard Deviation 3.3 |
| Manual Mini System | Intraocular Pressure | Immediate Post-Treatment (N=138, 140) | 14.3 mmHg | Standard Deviation 3.3 |
| Manual Mini System | Intraocular Pressure | 4 Weeks (138, 136) | 12.5 mmHg | Standard Deviation 2.9 |
| Warm Compress Therapy | Intraocular Pressure | Baseline (N=138, 140) | 14.0 mmHg | Standard Deviation 2.8 |
| Warm Compress Therapy | Intraocular Pressure | Immediate Post-Treatment (N=138, 140) | 15.0 mmHg | Standard Deviation 3.3 |
| Warm Compress Therapy | Intraocular Pressure | 4 Weeks (138, 136) | 13.1 mmHg | Standard Deviation 2.5 |
Secondary
(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
Population: Results presented are of the Intent to Treat population. 2 Weeks data for the Control group are after control treatment, but before crossover treatment. 4 Weeks data for the Control group are after crossover treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Manual Mini System | (LogMAR) Best Spectacle Corrected Visual Acuity | Baseline (N=138, 140) | 0.00 LogMAR | Standard Deviation 0.12 |
| Manual Mini System | (LogMAR) Best Spectacle Corrected Visual Acuity | 2 Weeks (N=136, 136) | -0.02 LogMAR | Standard Deviation 0.13 |
| Manual Mini System | (LogMAR) Best Spectacle Corrected Visual Acuity | 4 Weeks (N=138, 136) | -0.02 LogMAR | Standard Deviation 0.12 |
| Warm Compress Therapy | (LogMAR) Best Spectacle Corrected Visual Acuity | Baseline (N=138, 140) | 0.01 LogMAR | Standard Deviation 0.12 |
| Warm Compress Therapy | (LogMAR) Best Spectacle Corrected Visual Acuity | 2 Weeks (N=136, 136) | 0.02 LogMAR | Standard Deviation 0.13 |
| Warm Compress Therapy | (LogMAR) Best Spectacle Corrected Visual Acuity | 4 Weeks (N=138, 136) | -0.01 LogMAR | Standard Deviation 0.13 |
Secondary
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
Population: Results presented are of the Intent to Treat Population. 4 Weeks data for the Control group are after treatment crossover.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Manual Mini System | Ocular Surface Staining (Corneal Staining Sum Score) | Baseline | 2.2 Scores on a scale | Standard Deviation 2.2 |
| Manual Mini System | Ocular Surface Staining (Corneal Staining Sum Score) | 2 Weeks | 1.9 Scores on a scale | Standard Deviation 2 |
| Manual Mini System | Ocular Surface Staining (Corneal Staining Sum Score) | 4 Weeks | 1.5 Scores on a scale | Standard Deviation 1.7 |
| Warm Compress Therapy | Ocular Surface Staining (Corneal Staining Sum Score) | Baseline | 2.0 Scores on a scale | Standard Deviation 2 |
| Warm Compress Therapy | Ocular Surface Staining (Corneal Staining Sum Score) | 2 Weeks | 2.0 Scores on a scale | Standard Deviation 2.2 |
| Warm Compress Therapy | Ocular Surface Staining (Corneal Staining Sum Score) | 4 Weeks | 1.6 Scores on a scale | Standard Deviation 1.9 |