Treatment of Meibomian Gland Dysfunction and Dry Eye in Contact Lens Wearers
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: LipiFlow Single 12-minute LipiFlow treatment |
Device: 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.
Other Names:
|
| No Intervention: Untreated Control Untreated Control (No Intervention) |
|
| Experimental: Crossover LipiFlow Treatment Crossover LipiFlow treatment of the untreated control group after 3 months |
Device: 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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Mean Change in Meibomian Gland Score From Baseline at 3 Months [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.
Secondary Outcome Measures
- Mean Change in Dry Eye Questionnaire Score From Baseline at 3 Months [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.
Other Outcome Measures
- Mean Change in Comfortable Contact Lens Wear Time From Baseline at 3 Months [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.
- Mean Change in Meibomian Gland Score From Baseline at 1 Month [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.
- Mean Change in Dry Eye Questionnaire From Baseline at 1 Month [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.
- Mean Change in Comfortable Contact Lens Wear Time From Baseline at 1 Month [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Diagnosis of meibomian gland dysfunction and dry eye
-
At least 18 years of age
-
Willing to comply with randomization, attend all study visits and follow patient instructions
-
Habitual soft contact lens wearer 2 to 18 hours/day and 4 to 7 days/week
-
No change in contact lens type or dimensions for the past 3 months
-
Clinician assessment of acceptable contact lens fit and disinfecting solution
-
Tear film interferometry of 100 units or less
Exclusion Criteria:
-
Systemic disease conditions that cause dry eye
-
Use of systemic medications known to cause dryness
-
History of any of the following ocular conditions in the past 3 months: surgery, trauma, Herpes infection, recurrent inflammation, punctal plug insertion or punctal occlusion
-
Presence of any of the following active conditions: ocular infection, ocular inflammation, moderate to severe allergic conjunctivitis, severe eyelid inflammation, eyelid abnormality that affects lid function, or ocular surface abnormality that compromises corneal integrity
-
Use of other treatments for meibomian gland dysfunction or dry eye except over the counter lubricants or dietary supplements
-
Participation in another ophthalmic drug or device trial in the past month
-
Employee, relative of employee or associate of the clinical site
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | School of Optometry, The University of Alabama at Birmingham | Birmingham | Alabama | United States | 35294 |
| 2 | Clayton Eye Center | Morrow | Georgia | United States | 30260 |
| 3 | Charlotte Eye Ear Nose and Throat Associates, P.A. | Charlotte | North Carolina | United States | 28210 |
| 4 | May Eye Care Center & Associates | Hanover | Pennsylvania | United States | 17331 |
| 5 | Specialty Eyecare Group | Kirkland | Washington | United States | 98034 |
| 6 | Centre for Contact Lens Research | Waterloo | Ontario | Canada | N2L 3G1 |
Sponsors and Collaborators
- TearScience, Inc.
Investigators
- Study Director: Christy Coleman, OD, MPH, TearScience, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LF006
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | LipiFlow | Untreated Control | Crossover LipiFlow |
|---|---|---|---|
| Arm/Group Description | 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. | Untreated Control (No Intervention) | Untreated Control Subjects received a 12-minute LipiFlow treatment after the 3-month visit |
| Period Title: Randomized Study | |||
| STARTED | 29 | 26 | 0 |
| COMPLETED | 29 | 25 | 0 |
| NOT COMPLETED | 0 | 1 | 0 |
| Period Title: Randomized Study | |||
| STARTED | 0 | 0 | 25 |
| COMPLETED | 0 | 0 | 25 |
| NOT COMPLETED | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | LipiFlow | Untreated Control | Total |
|---|---|---|---|
| Arm/Group Description | 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. | Untreated Control (No Intervention) | Total of all reporting groups |
| Overall Participants | 29 | 26 | 55 |
| Overall Eyes | 58 | 52 | 110 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
40.0
(13.1)
|
43.5
(15.9)
|
41.7
(14.5)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
25
86.2%
|
22
84.6%
|
47
85.5%
|
| Male |
4
13.8%
|
4
15.4%
|
8
14.5%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
0
0%
|
1
3.8%
|
1
1.8%
|
| Not Hispanic or Latino |
29
100%
|
25
96.2%
|
54
98.2%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
6
20.7%
|
6
23.1%
|
12
21.8%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
5
17.2%
|
4
15.4%
|
9
16.4%
|
| White |
17
58.6%
|
16
61.5%
|
33
60%
|
| More than one race |
1
3.4%
|
0
0%
|
1
1.8%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (Count of Participants) | |||
| Canada |
8
27.6%
|
8
30.8%
|
16
29.1%
|
| United States |
21
72.4%
|
18
69.2%
|
39
70.9%
|
| Meibomian Gland Score (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
8.0
(3.5)
|
8.2
(4.2)
|
8.1
(3.8)
|
| SPEED Score (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
14.5
(4.8)
|
15.3
(4.5)
|
14.9
(4.6)
|
| Comfortable Contact Lens Wear Time (hours per day) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [hours per day] |
5.4
(3.4)
|
4.3
(3.1)
|
4.9
(3.3)
|
Outcome Measures
| Title | Mean Change in Meibomian Gland Score From Baseline at 3 Months |
|---|---|
| Description | 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. |
| Time Frame | 3 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to Treat (ITT) Population of all randomized subjects. |
| Arm/Group Title | LipiFlow | Untreated Control |
|---|---|---|
| Arm/Group Description | 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. | Untreated Control (No Intervention) |
| Measure Participants | 29 | 25 |
| Measure Eyes | 58 | 50 |
| Mean (95% Confidence Interval) [units on a scale] |
12.4
|
1.4
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | LipiFlow, Untreated Control |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 11.0 | |
| Confidence Interval |
(2-Sided) 95% 8.0 to 14.0 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Mean Change in Dry Eye Questionnaire Score From Baseline at 3 Months |
|---|---|
| Description | 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. |
| Time Frame | 3 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to Treat (ITT) Population of all randomized subjects. |
| Arm/Group Title | LipiFlow | Untreated Control |
|---|---|---|
| Arm/Group Description | 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. | Untreated Control (No Intervention) |
| Measure Participants | 29 | 25 |
| Mean (95% Confidence Interval) [units on a scale] |
-8.4
|
-0.7
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | LipiFlow, Untreated Control |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -7.7 | |
| Confidence Interval |
(2-Sided) 95% -10.2 to -5.2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Mean Change in Comfortable Contact Lens Wear Time From Baseline at 3 Months |
|---|---|
| Description | 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. |
| Time Frame | 3 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to Treat (ITT) of all randomized subjects |
| Arm/Group Title | LipiFlow | Untreated Control |
|---|---|---|
| Arm/Group Description | 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. | Untreated Control (No Intervention) |
| Measure Participants | 29 | 25 |
| Mean (95% Confidence Interval) [hours per day] |
3.7
|
-0.3
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | LipiFlow, Untreated Control |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 3.9 | |
| Confidence Interval |
(2-Sided) 95% 2.5 to 5.4 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Mean Change in Meibomian Gland Score From Baseline at 1 Month |
|---|---|
| Description | 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. |
| Time Frame | 1 Month |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to Treat (All randomized subjects) |
| Arm/Group Title | LipiFlow | Crossover LipiFlow Group |
|---|---|---|
| Arm/Group Description | 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. | Untreated Control Subjects received a 12-minute LipiFlow treatment after the 3-month visit |
| Measure Participants | 29 | 25 |
| Measure Eyes | 58 | 50 |
| Mean (95% Confidence Interval) [units on a scale] |
11.7
|
14.3
|
| Title | Mean Change in Dry Eye Questionnaire From Baseline at 1 Month |
|---|---|
| Description | 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. |
| Time Frame | 1 Month |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to Treat (All randomized subjects) |
| Arm/Group Title | LipiFlow | Crossover LipiFlow |
|---|---|---|
| Arm/Group Description | 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. | Untreated Control Subjects received a 12-minute LipiFlow treatment after the 3-month visit |
| Measure Participants | 29 | 25 |
| Measure Eyes | 58 | 50 |
| Mean (95% Confidence Interval) [units on a scale] |
-8.3
|
-8.1
|
| Title | Mean Change in Comfortable Contact Lens Wear Time From Baseline at 1 Month |
|---|---|
| Description | 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. |
| Time Frame | 1 Month |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to Treat (all randomized subjects) |
| Arm/Group Title | LipiFlow | Crossover LipiFlow Group |
|---|---|---|
| Arm/Group Description | 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. | Untreated Control Subjects received a 12-minute LipiFlow treatment after the 3-month visit |
| Measure Participants | 29 | 25 |
| Measure Eyes | 58 | 50 |
| Mean (95% Confidence Interval) [hours per day] |
4.0
|
3.7
|
Adverse Events
| Time Frame | 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. | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | 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. | |||||
| Arm/Group Title | LipiFlow | Untreated Control | Crossover LipiFlow Group | |||
| Arm/Group Description | 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. | Untreated Control (No Intervention) | Untreated Control Group received a single 12-minute Crossover LipiFlow treatment at the 3-Months visit. | |||
All Cause Mortality |
||||||
| LipiFlow | Untreated Control | Crossover LipiFlow Group | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/29 (0%) | 0/26 (0%) | 0/25 (0%) | |||
Serious Adverse Events |
||||||
| LipiFlow | Untreated Control | Crossover LipiFlow Group | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/29 (0%) | 0/26 (0%) | 0/25 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| LipiFlow | Untreated Control | Crossover LipiFlow Group | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/29 (0%) | 0/26 (0%) | 0/25 (0%) | |||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | VP Clinical and Regulatory Affairs |
|---|---|
| Organization | TearScience, Inc. |
| Phone | 919-467-4007 |
| regulatory@tearscience.com |
- LF006