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Treatment of Meibomian Gland Dysfunction and Dry Eye in Contact Lens Wearers

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ClinicalTrials.gov Identifier: NCT02102464
Recruitment Status : Completed
First Posted : April 3, 2014
Results First Posted : September 18, 2017
Last Update Posted : October 18, 2017
Sponsor:
Information provided by (Responsible Party):
TearScience, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Meibomian Gland Dysfunction
Dry Eye
Intervention Device: LipiFlow treatment
Enrollment 55
Recruitment Details  
Pre-assignment Details  
Arm/Group Title LipiFlow Untreated Control Crossover LipiFlow
Hide 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
Number of participants Number of units (Eyes) Number of participants Number of units (Eyes) Number of participants Number of units (Eyes)
Started 29 58 26 52 0 0
Completed 29 58 25 50 0 0
Not Completed 0 0 1 2 0 0
Reason Not Completed
Withdrawal by Subject             0                         1                         0            
Period Title: Crossover LipiFlow Treatment of Control
Number of participants Number of units (Eyes) Number of participants Number of units (Eyes) Number of participants Number of units (Eyes)
Started 0 0 0 0 25 50
Completed 0 0 0 0 25 50
Not Completed 0 0 0 0 0 0
Arm/Group Title LipiFlow Untreated Control Total
Hide 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 Number of Baseline Participants 29 26 55
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
58 52 110
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 29 participants 26 participants 55 participants
40.0  (13.1) 43.5  (15.9) 41.7  (14.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 26 participants 55 participants
Female
25
  86.2%
22
  84.6%
47
  85.5%
Male
4
  13.8%
4
  15.4%
8
  14.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 26 participants 55 participants
Hispanic or Latino
0
   0.0%
1
   3.8%
1
   1.8%
Not Hispanic or Latino
29
 100.0%
25
  96.2%
54
  98.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 26 participants 55 participants
American Indian or Alaska Native
0
   0.0%
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%
0
   0.0%
Black or African American
5
  17.2%
4
  15.4%
9
  16.4%
White
17
  58.6%
16
  61.5%
33
  60.0%
More than one race
1
   3.4%
0
   0.0%
1
   1.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 26 participants 55 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   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 58 Eyes 52 Eyes 110 Eyes
8.0  (3.5) 8.2  (4.2) 8.1  (3.8)
[1]
Measure Description: 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.
SPEED Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 29 participants 26 participants 55 participants
14.5  (4.8) 15.3  (4.5) 14.9  (4.6)
[1]
Measure Description: 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).
Comfortable Contact Lens Wear Time   [1] 
Mean (Standard Deviation)
Unit of measure:  Hours per day
Number Analyzed 29 participants 26 participants 55 participants
5.4  (3.4) 4.3  (3.1) 4.9  (3.3)
[1]
Measure Description: 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).
1.Primary Outcome
Title Mean Change in Meibomian Gland Score From Baseline at 3 Months
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) Population of all randomized subjects.
Arm/Group Title LipiFlow Untreated Control
Hide 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)
Overall Number of Participants Analyzed 29 25
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
58 50
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
12.4
(10.0 to 14.8)
1.4
(-0.4 to 3.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LipiFlow, Untreated Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 11.0
Confidence Interval (2-Sided) 95%
8.0 to 14.0
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Mean Change in Dry Eye Questionnaire Score From Baseline at 3 Months
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) Population of all randomized subjects.
Arm/Group Title LipiFlow Untreated Control
Hide 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)
Overall Number of Participants Analyzed 29 25
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-8.4
(-10.2 to -6.6)
-0.7
(-2.5 to 1.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LipiFlow, Untreated Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -7.7
Confidence Interval (2-Sided) 95%
-10.2 to -5.2
Estimation Comments [Not Specified]
3.Other Pre-specified Outcome
Title Mean Change in Comfortable Contact Lens Wear Time From Baseline at 3 Months
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) of all randomized subjects
Arm/Group Title LipiFlow Untreated Control
Hide 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)
Overall Number of Participants Analyzed 29 25
Mean (95% Confidence Interval)
Unit of Measure: hours per day
3.7
(2.8 to 4.5)
-0.3
(-0.8 to 0.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LipiFlow, Untreated Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.9
Confidence Interval (2-Sided) 95%
2.5 to 5.4
Estimation Comments [Not Specified]
4.Other Pre-specified Outcome
Title Mean Change in Meibomian Gland Score From Baseline at 1 Month
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (All randomized subjects)
Arm/Group Title LipiFlow Crossover LipiFlow Group
Hide 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
Overall Number of Participants Analyzed 29 25
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
58 50
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
11.7
(9.2 to 14.2)
14.3
(11.1 to 17.5)
5.Other Pre-specified Outcome
Title Mean Change in Dry Eye Questionnaire From Baseline at 1 Month
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (All randomized subjects)
Arm/Group Title LipiFlow Crossover LipiFlow
Hide 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
Overall Number of Participants Analyzed 29 25
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
58 50
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-8.3
(-10.1 to -6.5)
-8.1
(-10.7 to -5.5)
6.Other Pre-specified Outcome
Title Mean Change in Comfortable Contact Lens Wear Time From Baseline at 1 Month
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (all randomized subjects)
Arm/Group Title LipiFlow Crossover LipiFlow Group
Hide 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
Overall Number of Participants Analyzed 29 25
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
58 50
Mean (95% Confidence Interval)
Unit of Measure: hours per day
4.0
(2.9 to 5.1)
3.7
(2.5 to 4.8)
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
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/29 (0.00%)   0/26 (0.00%)   0/25 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
LipiFlow Untreated Control Crossover LipiFlow Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/29 (0.00%)   0/26 (0.00%)   0/25 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
LipiFlow Untreated Control Crossover LipiFlow Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/29 (0.00%)   0/26 (0.00%)   0/25 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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
Responsible Party: TearScience, Inc.
ClinicalTrials.gov Identifier: NCT02102464     History of Changes
Other Study ID Numbers: LF006
First Submitted: March 30, 2014
First Posted: April 3, 2014
Results First Submitted: August 18, 2017
Results First Posted: September 18, 2017
Last Update Posted: October 18, 2017