Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manual Mini System | Experimental | Treatment with experimental Manual Mini System |
|
| Warm Compress Therapy | Active Comparator | Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Manual Mini System | Device | In-office device treatment for meibomian gland dysfunction by a physician |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 2 Weeks and 4 Weeks |
| Incidence of Device-related Adverse Events | Number of eyes for which a device-related AE occurred | 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. | Baseline, 2 Weeks and 4 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 2 Weeks and 4 Weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Christy Stevens, OD | TearScience, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fayetteville | Arkansas | United States | ||||
At the 2 Week visit, Control subjects stopped the warm compress therapy and received a single Manual Mini (LipiFlow) crossover treatment.
A total of 139 subjects (278 eyes) were enrolled at nine clinical sites between 03/04/2009 and 05/14/2009.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Manual Mini System | Treatment with experimental Manual Mini System |
| FG001 | Warm Compress Therapy | Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| iHeat Portable Warm Compress Therapy | Device | At-home daily warm compress therapy |
|
| 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. | 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. | 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. | 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. | Treatment and 1 Day |
| Morrow |
| Georgia |
| United States |
| Highland Park | Illinois | United States |
| Edgewood | Kentucky | United States |
| Lexington | Kentucky | United States |
| Winchester | Massachusetts | United States |
| Jackson | Michigan | United States |
| Bloomington | Minnesota | United States |
| Stillwater | Minnesota | United States |
| Charlotte | North Carolina | United States |
| Lancaster | Pennsylvania | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Manual Mini System | Treatment with experimental Manual Mini System |
| BG001 | Warm Compress Therapy | Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Results presented are for the Per Protocol population. 4 Weeks data for the Warm Compress Control group are after crossover. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, 2 Weeks and 4 Weeks | Eyes | Participants |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Incidence of Device-related Adverse Events | Number of eyes for which a device-related AE occurred | Results presented are of the Intent to Treat Population. | Posted | Number | Events | Baseline through 4 Weeks | Eyes | Participants |
|
| |||||||||||||||||||||||||||||||||||||
| 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. | Results presented are for the Per Protocol population. 4 Weeks data for the Warm Compress Control group are after crossover. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, 2 Weeks and 4 Weeks | Eyes | Participants |
|
| ||||||||||||||||||||||||||||||||||||
| 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. | Results presented are of the Intent to Treat Population. 4 Weeks data for the Control group are after treatment crossover. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline through 4 Weeks | Eyes | Participants |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Intraocular Pressure | Intraocular pressure (IOP) was evaluated by Goldmann applanation tonometry. Change in IOP from Baseline was assessed to confirm safety. | 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. | Posted | Mean | Standard Deviation | mmHg | Baseline through 4 Weeks | Eyes | Participants |
|
| ||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | LogMAR | Baseline, 2 Weeks and 4 Weeks | Eyes | Participants |
|
| ||||||||||||||||||||||||||||||||||||
| 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. | Results presented are of the Intent to Treat population. Only the Manual Mini group underwent a 1 day assessment. | Posted | Mean | Standard Deviation | Scores on a scale | Treatment and 1 Day | Eyes | Participants |
|
| ||||||||||||||||||||||||||||||||||||
| 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. | Results presented are for the Per Protocol population. 4 Weeks data for the Warm Compress Control group are after crossover. | Posted | Mean | Standard Deviation | Seconds | Baseline, 2 Weeks and 4 Weeks | Eyes | Participants |
|
|
The presence of adverse events was evaluated at all study visits, including unscheduled visits.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Manual Mini System | Treatment with experimental Manual Mini System | 1 | 69 | 0 | 69 | ||
| EG001 | Warm Compress Therapy | Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase | 1 | 70 | 0 | 70 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Elective Knee Surgery | Musculoskeletal and connective tissue disorders | Systematic Assessment | The AE was systemic and unrelated to the device and study procedures. |
| |
| Stroke | Vascular disorders | Systematic Assessment | The AE was systemic and unrelated to the device and study procedures. |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christy Stevens, OD | TearScience, Inc. (formerly Kolis Scientific) | 919-459-4815 | cstevens@tearscience.com |
| ID | Term |
|---|---|
| D017043 | Chalazion |
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D003560 | Cysts |
| D009369 | Neoplasms |
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
| D007766 | Lacrimal Apparatus Diseases |
Not provided
Not provided
| Male |
|
| 4 Weeks (N=128, 132) |
|
| Eyes |
|
|
| Eyes |
|
|
| Eyes |
|
|
| Eyes |
|
|
| Eyes |
|
|
| Eyes |
|
|
| Eyes |
|
|