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The pilot study objective is to evaluate the potential benefits of LipiFlow® System treatment of contact lens wearers with meibomian gland dysfunction and evaporative dry eye by assessing for improvement in meibomian gland function and reduction of dry eye symptoms in comparison to an untreated control.
This is a prospective, non-significant risk, open-label, randomized clinical trial of LipiFlow® treatment of contact lens wearers with meibomian gland dysfunction and evaporative dry eye. All subjects undergo examination to determine study eligibility and to capture the Baseline status. Subjects are randomized to receive LipiFlow® treatment (Treatment Group) or no LipiFlow® treatment (Untreated Control Group). The Treatment group is evaluated one month after receiving LipiFlow® treatment. Study endpoints are evaluated at 3 Months by comparing the Treatment Group to the Untreated Group. To facilitate subject recruitment, the Untreated Control group receives Crossover LipiFlow® treatment (Crossover Treatment Group) at 3 Months. The Crossover Treatment group is evaluated one month after receiving LipiFlow® treatment (4 Months visit).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LipiFlow | Experimental | Single 12-minute LipiFlow treatment |
|
| Untreated Control | No Intervention | Untreated Control (No Intervention) | |
| Crossover LipiFlow Treatment | Experimental | Crossover LipiFlow treatment of the untreated control group after 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LipiFlow treatment | Device | The LipiFlow® Thermal Pulsation System is a prescription device intended for the application of localized heat and pressure 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Meibomian Gland Score From Baseline at 3 Months | The Primary Endpoint was intended to assess for improvement in meibomian gland function in symptomatic contact lens wearers after LipiFlow treatment in comparison to an untreated control.The Primary Endpoint was defined as the mean change in meibomian gland score in the LipiFlow Treatment group compared to Untreated Control group from Baseline to 3 Months. To determine the meibomian gland score, secretion characteristics of 15 meibomian glands along the lower eyelid were evaluated including five glands each in the temporal, central and nasal regions of the lower eyelid. For each gland, secretion characteristics were graded as 3 (clear liquid), 2 (cloudy liquid), 1 (inspissated/ toothpaste consistency) and 0 (no secretion). The total meibomian gland score is the sum of the grades for all 15 glands with a range between 0 and 45. A higher score reflects less meibomian gland dysfunction. | 3 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Dry Eye Questionnaire Score From Baseline at 3 Months | The Secondary Endpoint was intended to assess for reduction in dry eye symptoms in symptomatic contact lens after LipiFlow treatment in comparison to an untreated control using the Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire. The Secondary Endpoint was defined as the mean change in SPEED score in the LipiFlow Treatment group compared to Untreated Control group from Baseline to 3 Months. Dry eye symptoms evaluated were dryness, grittiness or scratchiness; soreness or irritation; burning or watering; and eye fatigue. Symptom frequency and severity were assessed. The SPEED score is the sum of frequency and severity scores with a range from 0 to 28. A lower SPEED score represents less frequent and/or less severe symptoms. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Comfortable Contact Lens Wear Time From Baseline at 3 Months | Subjects reported how long they wore their contact lenses per day (total contact lens wear time) and how long the contact lenses were comfortable (comfortable contact lens wear time). A pre-specified exploratory analysis was to compare the mean change in comfortable contact lens wear time between Baseline and 3 Months for the LipiFlow group vs. untreated control. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christy Coleman, OD, MPH | TearScience, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Optometry, The University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | LipiFlow | Single 12-minute LipiFlow treatment LipiFlow treatment: The LipiFlow® Thermal Pulsation System is a prescription device intended for the application of localized heat and pressure 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. |
| FG001 | Untreated Control | Untreated Control (No Intervention) |
| FG002 | Crossover LipiFlow | Untreated Control Subjects received a 12-minute LipiFlow treatment after the 3-month visit |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Randomized Study |
|
| ||||||||||||||||||
| Crossover LipiFlow Treatment of Control |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | LipiFlow | Single 12-minute LipiFlow treatment LipiFlow treatment: The LipiFlow® Thermal Pulsation System is a prescription device intended for the application of localized heat and pressure 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Mean Change in Meibomian Gland Score From Baseline at 3 Months | The Primary Endpoint was intended to assess for improvement in meibomian gland function in symptomatic contact lens wearers after LipiFlow treatment in comparison to an untreated control.The Primary Endpoint was defined as the mean change in meibomian gland score in the LipiFlow Treatment group compared to Untreated Control group from Baseline to 3 Months. To determine the meibomian gland score, secretion characteristics of 15 meibomian glands along the lower eyelid were evaluated including five glands each in the temporal, central and nasal regions of the lower eyelid. For each gland, secretion characteristics were graded as 3 (clear liquid), 2 (cloudy liquid), 1 (inspissated/ toothpaste consistency) and 0 (no secretion). The total meibomian gland score is the sum of the grades for all 15 glands with a range between 0 and 45. A higher score reflects less meibomian gland dysfunction. | Intent to Treat (ITT) Population of all randomized subjects. | Posted | Mean | 95% Confidence Interval | units on a scale | 3 Months | Eyes | Eyes |
|
Device-related adverse event data were analyzed over the entire study duration. For the LipiFlow Group, this time frame was 3 months. For the Crossover LipiFlow Group, the time frame was one month follow-up after receiving crossover LipiFlow treatment of the untreated control subjects at the 3-Month visit.
An adverse event was defined as any untoward medical occurrence in a subject in association with use of the device or study procedure. Investigators were required to document adverse events and assess the causal relationship with the device or study procedure. The Medical Monitor reviewed adverse events as they were reported by Investigators.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LipiFlow | Single 12-minute LipiFlow treatment LipiFlow treatment: The LipiFlow® Thermal Pulsation System is a prescription device intended for the application of localized heat and pressure 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP Clinical and Regulatory Affairs | TearScience, Inc. | 919-467-4007 | regulatory@tearscience.com |
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| ID | Term |
|---|---|
| D000080343 | Meibomian Gland Dysfunction |
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
| D007766 | Lacrimal Apparatus Diseases |
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|
|
| 3 Months |
| 3 Months |
| Mean Change in Meibomian Gland Score From Baseline at 1 Month | The mean change in meibomian gland score from Baseline was also evaluated at 1 Month post-LipiFlow treatment for the LipiFlow and Crossover LipiFlow Groups. The LipiFlow Group was assessed at the 1-Month visit. The Crossover LipiFlow Group was assessed at the 4-Month visit (one month after receiving crossover LipiFlow treatment). There was no planned statistical analysis comparison between the LipiFlow and Crossover LipiFlow groups at 1 Month. To determine the meibomian gland score, secretion characteristics of 15 meibomian glands along the lower eyelid were evaluated including five glands each in the temporal, central and nasal regions of the lower eyelid. For each gland, secretion characteristics were graded as 3 (clear liquid), 2 (cloudy liquid), 1 (inspissated/ toothpaste consistency) and 0 (no secretion). The total meibomian gland score is the sum of the grades for all 15 glands with a range between 0 and 45. A higher score reflects less meibomian gland dysfunction. | 1 Month |
| Mean Change in Dry Eye Questionnaire From Baseline at 1 Month | The mean change in dry eye symptoms from Baseline based on the SPEED questionnaire score was also evaluated at 1 Month post-LipiFlow treatment for the LipiFlow and Crossover LipiFlow Groups. The LipiFlow Group was assessed at the 1-Month visit. The Crossover LipiFlow Group was assessed at the 4-Month visit (one month after receiving cossover LipiFlow treatment). There was no planned statistical analysis comparison between the LipiFlow and Crossover LipiFlow groups at 1 Month. Dry eye symptoms evaluated were dryness, grittiness or scratchiness; soreness or irritation; burning or watering; and eye fatigue. Symptom frequency and severity were assessed. The SPEED score is the sum of frequency and severity scores with a range from 0 to 28. A lower SPEED score represents less frequent and/or less severe symptoms. | 1 Month |
| Mean Change in Comfortable Contact Lens Wear Time From Baseline at 1 Month | Subjects reported how long they wore their contact lenses per day (total contact lens wear time) and how long the contact lenses were comfortable (comfortable contact lens wear time). The mean change in comfortable contact lens wear time from Baseline was also evaluated at 1 Month post-LipiFlow treatment for the LipiFlow and Crossover LipiFlow Groups. The LipiFlow Group was assessed at the 1-Month visit. The Crossover LipiFlow Group was assessed at the 4-Month visit (one month after receiving cossover LipiFlow treatment). There was no planned statistical analysis comparison between the LipiFlow and Crossover LipiFlow groups at 1 Month. | 1 Month |
| Clayton Eye Center |
| Morrow |
| Georgia |
| 30260 |
| United States |
| Charlotte Eye Ear Nose and Throat Associates, P.A. | Charlotte | North Carolina | 28210 | United States |
| May Eye Care Center & Associates | Hanover | Pennsylvania | 17331 | United States |
| Specialty Eyecare Group | Kirkland | Washington | 98034 | United States |
| Centre for Contact Lens Research | Waterloo | Ontario | N2L 3G1 | Canada |
| NOT COMPLETED |
|
| BG001 |
| Untreated Control |
Untreated Control (No Intervention) |
| BG002 | Total | Total of all reporting groups |
| Eyes |
|
| years |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants | Participants |
|
| Meibomian Gland Score | Along the lower lid, secretion characteristics of 15 meibomian glands were evaluated including five glands each in the temporal, central and nasal regions of the lower eyelid. For each gland, secretion characteristics were graded as 3 (clear liquid), 2 (cloudy liquid), 1 (inspissated/ toothpaste consistency) and 0 (no secretion). The total meibomian gland score is the sum of the grades for all 15 glands with a range between 0 and 45. A higher score reflects less meibomian gland dysfunction. | Mean | Standard Deviation | units on a scale | Eyes |
|
| SPEED Score | Using Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire, symptoms evaluated were dryness, grittiness or scratchiness; soreness or irritation; burning or watering; and eye fatigue. Frequency scale: 0 (never), 1 (sometimes), 2 (often) and 3 (constant). Severity scale: 0 (no problems), 1 (tolerable-not perfect but not uncomfortable), 2 (uncomfortable-irritating but does not interfere with my day), 3 (bothersome-irritating and interferes with my day) and 4 (intolerable-unable to perform my daily tasks). SPEED score is the sum of frequency and severity scores (range 0 to 28). | Mean | Standard Deviation | units on a scale | Participants |
|
| Comfortable Contact Lens Wear Time | Subjects reported how long they wore their contact lenses each day (total contact lens wear time), and how long the contact lens wear was comfortable (comfortable contact lens wear time). | Mean | Standard Deviation | hours per day | Participants |
|
| OG000 | LipiFlow | Single 12-minute LipiFlow treatment LipiFlow treatment: The LipiFlow® Thermal Pulsation System is a prescription device intended for the application of localized heat and pressure 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. |
| OG001 | Untreated Control | Untreated Control (No Intervention) |
|
|
|
| Secondary | Mean Change in Dry Eye Questionnaire Score From Baseline at 3 Months | The Secondary Endpoint was intended to assess for reduction in dry eye symptoms in symptomatic contact lens after LipiFlow treatment in comparison to an untreated control using the Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire. The Secondary Endpoint was defined as the mean change in SPEED score in the LipiFlow Treatment group compared to Untreated Control group from Baseline to 3 Months. Dry eye symptoms evaluated were dryness, grittiness or scratchiness; soreness or irritation; burning or watering; and eye fatigue. Symptom frequency and severity were assessed. The SPEED score is the sum of frequency and severity scores with a range from 0 to 28. A lower SPEED score represents less frequent and/or less severe symptoms. | Intent to Treat (ITT) Population of all randomized subjects. | Posted | Mean | 95% Confidence Interval | units on a scale | 3 Months |
|
|
|
|
| Other Pre-specified | Mean Change in Comfortable Contact Lens Wear Time From Baseline at 3 Months | Subjects reported how long they wore their contact lenses per day (total contact lens wear time) and how long the contact lenses were comfortable (comfortable contact lens wear time). A pre-specified exploratory analysis was to compare the mean change in comfortable contact lens wear time between Baseline and 3 Months for the LipiFlow group vs. untreated control. | Intent to Treat (ITT) of all randomized subjects | Posted | Mean | 95% Confidence Interval | hours per day | 3 Months |
|
|
|
|
| Other Pre-specified | Mean Change in Meibomian Gland Score From Baseline at 1 Month | The mean change in meibomian gland score from Baseline was also evaluated at 1 Month post-LipiFlow treatment for the LipiFlow and Crossover LipiFlow Groups. The LipiFlow Group was assessed at the 1-Month visit. The Crossover LipiFlow Group was assessed at the 4-Month visit (one month after receiving crossover LipiFlow treatment). There was no planned statistical analysis comparison between the LipiFlow and Crossover LipiFlow groups at 1 Month. To determine the meibomian gland score, secretion characteristics of 15 meibomian glands along the lower eyelid were evaluated including five glands each in the temporal, central and nasal regions of the lower eyelid. For each gland, secretion characteristics were graded as 3 (clear liquid), 2 (cloudy liquid), 1 (inspissated/ toothpaste consistency) and 0 (no secretion). The total meibomian gland score is the sum of the grades for all 15 glands with a range between 0 and 45. A higher score reflects less meibomian gland dysfunction. | Intent to Treat (All randomized subjects) | Posted | Mean | 95% Confidence Interval | units on a scale | 1 Month | Eyes | Eyes |
|
|
|
| Other Pre-specified | Mean Change in Dry Eye Questionnaire From Baseline at 1 Month | The mean change in dry eye symptoms from Baseline based on the SPEED questionnaire score was also evaluated at 1 Month post-LipiFlow treatment for the LipiFlow and Crossover LipiFlow Groups. The LipiFlow Group was assessed at the 1-Month visit. The Crossover LipiFlow Group was assessed at the 4-Month visit (one month after receiving cossover LipiFlow treatment). There was no planned statistical analysis comparison between the LipiFlow and Crossover LipiFlow groups at 1 Month. Dry eye symptoms evaluated were dryness, grittiness or scratchiness; soreness or irritation; burning or watering; and eye fatigue. Symptom frequency and severity were assessed. The SPEED score is the sum of frequency and severity scores with a range from 0 to 28. A lower SPEED score represents less frequent and/or less severe symptoms. | Intent to Treat (All randomized subjects) | Posted | Mean | 95% Confidence Interval | units on a scale | 1 Month | Eyes | Eyes |
|
|
|
| Other Pre-specified | Mean Change in Comfortable Contact Lens Wear Time From Baseline at 1 Month | Subjects reported how long they wore their contact lenses per day (total contact lens wear time) and how long the contact lenses were comfortable (comfortable contact lens wear time). The mean change in comfortable contact lens wear time from Baseline was also evaluated at 1 Month post-LipiFlow treatment for the LipiFlow and Crossover LipiFlow Groups. The LipiFlow Group was assessed at the 1-Month visit. The Crossover LipiFlow Group was assessed at the 4-Month visit (one month after receiving cossover LipiFlow treatment). There was no planned statistical analysis comparison between the LipiFlow and Crossover LipiFlow groups at 1 Month. | Intent to Treat (all randomized subjects) | Posted | Mean | 95% Confidence Interval | hours per day | 1 Month | Eyes | Eyes |
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | Untreated Control | Untreated Control (No Intervention) | 0 | 26 | 0 | 26 | 0 | 26 |
| EG002 | Crossover LipiFlow Group | Untreated Control Group received a single 12-minute Crossover LipiFlow treatment at the 3-Months visit. | 0 | 25 | 0 | 25 | 0 | 25 |
Within 18 months of Sponsor's receipt of data from all sites, Investigators may publish or present the Investigator's individual results. Investigator must submit materials to Sponsor for review and comment at least 30 days prior to presentation or submission for publication. Investigator will consider all reasonable comments from Sponsor. Upon Sponsor's written request, Investigator agrees to delete any Proprietary Information other than Investigator's individual Study results.