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Comparison Between iLux™ and LipiFlow® in the Treatment of Meibomian Gland Dysfunction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03055832
Recruitment Status : Completed
First Posted : February 16, 2017
Results First Posted : May 20, 2019
Last Update Posted : May 30, 2019
Sponsor:
Information provided by (Responsible Party):
Tear Film Innovations, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Meibomian Gland Dysfunction
Interventions Device: iLux 2020 System
Device: LipiFlow Pulsation System
Enrollment 142
Recruitment Details  
Pre-assignment Details  
Arm/Group Title iLux 2020 System LipiFlow Thermal Pulsation System
Hide Arm/Group Description Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual
Period Title: Baseline
Started 71 71
Completed 71 71
Not Completed 0 0
Period Title: Immediately Post-Procedure (Hour 1)
Started 71 71
Completed 71 71
Not Completed 0 0
Period Title: Day 1
Started 71 71
Completed 71 71
Not Completed 0 0
Period Title: Week 2
Started 71 71
Completed 70 71
Not Completed 1 0
Reason Not Completed
Withdrawal by Subject             1             0
Period Title: Week 4
Started 70 71
Completed 70 71
Not Completed 0 0
Arm/Group Title iLux 2020 System LipiFlow Thermal Pulsation System Total
Hide Arm/Group Description Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual Total of all reporting groups
Overall Number of Baseline Participants 71 71 142
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants 71 participants 142 participants
Under 18 Years
0
   0.0%
0
   0.0%
0
   0.0%
18 Years and Older
71
 100.0%
71
 100.0%
142
 100.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants 71 participants 142 participants
Female
52
  73.2%
49
  69.0%
101
  71.1%
Male
19
  26.8%
22
  31.0%
41
  28.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants 71 participants 142 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
3
   4.2%
1
   1.4%
4
   2.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
4
   5.6%
1
   1.4%
5
   3.5%
White
61
  85.9%
68
  95.8%
129
  90.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
3
   4.2%
1
   1.4%
4
   2.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 71 participants 71 participants 142 participants
71 71 142
1.Primary Outcome
Title Change From Baseline to Week 4 in Meibomian Gland Score (MGS)
Hide Description Meibomian glands on the lower eyelid were assessed by the examiner using a Meibomian Gland Evaluator while viewing the eyelid margin using a slit lamp microscope. 5 glands in 3 zones (nasal, medial, temporal) were evaluated. Each gland was scored from 0-3 for a maximum MGS of 45 in each eye. MGS scoring was as follows: 0 = no secretion (worst), 1 = inspissated, 2 = cloudy, 3 = clear liquid (best). A positive change value indicates an improvement.
Time Frame Baseline, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized and treated patients
Arm/Group Title iLux Right Eye iLux Left Eye iLux Both Eyes LipiFlow Right Eye LipiFlow Left Eye LipiFlow Both Eyes
Hide Arm/Group Description:
Right Eye of Subjects treated with the iLux 2020 System
Left Eye of Subjects treated with the iLux 2020 System
Both Eyes of Subjects treated with the iLux 2020 System
Right Eye of Subjects Treated with the LipiFlow Thermal Pulsation System
Left Eye of Subjects treated with Lipiflow Thermal Pulsation System
Both Eyes of Subjects treated with the LipiFlow Thermal Pulsation System
Overall Number of Participants Analyzed 70 70 70 70 71 71
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
70 70 140 70 71 141
Mean (Standard Deviation)
Unit of Measure: score on a scale
17.3  (12.1) 18.0  (12.2) 17.7  (12.2) 18.1  (10.8) 16.9  (11.5) 17.5  (11.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection iLux Both Eyes, LipiFlow Both Eyes
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments

This study provides a combined power of co-primary endpoints of 88% given the following primary endpoint assumptions:

  • MGS non-inferiority delta of 5 points and standard deviation of 8 points provides power of 93.9%
  • TBT non-inferiority delta of 2.5 seconds and standard deviation of 4 seconds, provides a TBT primary endpoint power of 93.9%
  • Power that both endpoitns are significant, assuming independence was 0.939^2 = 0.882 or 88.2% power.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.13
Confidence Interval (2-Sided) 95%
-3.82 to 3.56
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.88
Estimation Comments [Not Specified]
2.Primary Outcome
Title Change From Baseline to Week 4 in Tear Break-Up Time (TBT)
Hide Description Tear break-up time (defined as the time required for dry spots to appear on the surface of the eye after blinking) was assessed by the examiner using a slit lamp and fluorescein strips. Fluorescein was instilled onto the patient's eye, after which the patient blinked three times, then kept the eye open. Immediately thereafter, the examiner used a stopwatch to record the time between the last blink and the first appearance of a dark spot on the cornea (formation of dry area). Three consecutive measurements were taken and averaged for actual TBT. A positive change value represents a lengthening in the tear break-up time and greater comfort.
Time Frame Baseline, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized and treated patients
Arm/Group Title iLux Right Eye iLux Left Eye iLux Both Eyes LipiFlow Right Eye LipiFlow Left Eye LipiFlow Both Eyes
Hide Arm/Group Description:
Right Eye of Subjects treated with the iLux 2020 System
Left Eye of Subjects treated with the iLux 2020 System
Both Eyes of Subjects treated with the iLux 2020 System
Right Eye of Subjects Treated with the LipiFlow Thermal Pulsation System
Left Eye of Subjects treated with Lipiflow Thermal Pulsation System
Both Eyes of Subjects treated with the LipiFlow Thermal Pulsation System
Overall Number of Participants Analyzed 70 70 70 71 71 71
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
70 70 140 71 71 142
Mean (Standard Deviation)
Unit of Measure: seconds
2.86  (3.72) 2.73  (3.72) 2.79  (3.66) 2.69  (3.31) 2.61  (3.22) 2.65  (3.25)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection iLux Both Eyes, LipiFlow Both Eyes
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments

This study provides a combined power of co-primary endpoints of 88% given the following primary endpoint assumptions:

  • MGS non-inferiority delta of 5 points and standard deviation of 8 points provides power of 93.9%
  • TBT non-inferiority delta of 2.5 seconds and standard deviation of 4 seconds, provides a TBT primary endpoint power of 93.9%
  • Power that both endpoitns are significant, assuming independence was 0.939^2 = 0.882 or 88.2% power.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.10
Confidence Interval (2-Sided) 95%
-0.97 to 1.16
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.54
Estimation Comments [Not Specified]
3.Primary Outcome
Title Incidence (Number) of Device- or Procedure-related Adverse Events
Hide Description The number of device- or procedure-related adverse events was calculated, including changes from baseline (Yes/No) in any of the following eyelid characteristics: lid margin assessment or development of floppy eyelids or entropion (eyelid rolled inward) or ectropion (eyelid sagging outward) or loss of lash integrity.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized and treated patients
Arm/Group Title iLux 2020 System LipiFlow Thermal Pulsation System
Hide Arm/Group Description:

Meibomian Gland Treatment

iLux 2020 System: Heating and compression to express clogged meibomian glands

Meibomian Gland Treatment

LipiFlow Pulsation System: Heating and compression to express clogged meibomian glands

Overall Number of Participants Analyzed 70 71
Measure Type: Number
Unit of Measure: Adverse event
4 0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection iLux 2020 System, LipiFlow Thermal Pulsation System
Comments [Not Specified]
Type of Statistical Test Other
Comments A formal hypothesis was not proposed for this endpoint and therefore a power calculation was not performed. A Fisher's Exact test was performed post hoc to determine if a significant difference existed between the two arms.
Statistical Test of Hypothesis P-Value 0.12
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline to Week 4 in Ocular Surface Disease Index (OSDI)
Hide Description The Ocular Surface Disease Index (OSDI) is a 12-item, patient-reported outcome questionnaire used to measure ocular symptoms, visual function, and environmental factors that may affect a patient's vision. Each item is scored on a 0-4 Likert-type scale, where 0 is "None" and 4 is "All of the Time." The OSDI is calculated as the (sum of scores) x 25 / (# of questions answered), for a resultant overall score of 0-100, where 0 corresponds to no disability and 100 corresponds to complete disability. A negative change value indicates an improvement.
Time Frame Baseline, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized and treated patients
Arm/Group Title iLux All Questions iLux Vision Questions iLux Ocular Questions iLux Trigger Questions LipiFlow All Questions LipiFlow Vision Questions LipiFlow Ocular Questions LipiFlow Trigger Questions
Hide Arm/Group Description:
All OSDI questions in Subjects treated with the iLux 2020 System
OSDI Questions 1-5 in Subjects Treated with the iLux 2020 System
OSDI questions 6-9 in Subjects treated with the iLux 2020 System
OSDI questions 10-12 in Subjects treated with the iLux 2020 System
All OSDI questions (1-12) in Subjects treated with the LipiFlow Thermal Pulsation System
OSDI Questions 1-5 in Subjects treated with the LipiFlow Thermal Pulsation System
OSDI questions 6-9 in Subjects treated with the LipiFlow Thermal Pulsation System
OSDI questions 10-12 in Subjects treated with the LipiFlow Thermal Pulsation System
Overall Number of Participants Analyzed 70 70 70 70 71 71 70 71
Mean (Standard Deviation)
Unit of Measure: score on a scale
-31.0  (18.4) -27.3  (19.7) -30.9  (25.9) -37.0  (30.6) -28.0  (22.8) -24.9  (20.0) -27.5  (28.4) -34.4  (34.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection iLux All Questions, LipiFlow All Questions
Comments All questions
Type of Statistical Test Non-Inferiority
Comments A standard deviation of 14 was assumed based on pilot data and the non-inferiority delta was set to 7. The chosen sample size and alpha = 0.025 provides 80% power for this endpoint
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -3.08
Confidence Interval (2-Sided) 95%
-8.75 to 2.59
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.89
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Mean Pain Score During Treatment
Hide Description The patient placed a vertical line on visual analog scale questionnaire using a scale of 0-100 (0 = no pain, 100 = maximum pain) at the point that indicated the pain in or around their eyelids, or face during the procedure including feelings of pressure, tightness, heaviness, burning, and other negative sensations. A score a 20 was associated with a description of "hurts a little". Assessments were made at baseline (pre-treatment), immediately post-treatment, and Day 1 post-treatment. No formal hypothesis testing was pre-specified for this endpoint.
Time Frame Baseline (Day 0), Immediately Post-Treatment (Day 0), Day 1 Post-Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized and treated patients
Arm/Group Title iLux Right Eye iLux Left Eye iLux Both Eyes LipiFlow Right Eye LipiFlow Left Eye LipiFlow Both Eyes
Hide Arm/Group Description:
Right Eye of Subjects treated with the iLux 2020 System
Left Eye of Subjects treated with the iLux 2020 System
Both Eyes of Subjects treated with the iLux 2020 System
Right Eye of Subjects Treated with the LipiFlow Thermal Pulsation System
Left Eye of Subjects treated with Lipiflow Thermal Pulsation System
Both Eyes of Subjects treated with the LipiFlow Thermal Pulsation System
Overall Number of Participants Analyzed 71 71 71 69 70 70
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
71 71 142 69 70 139
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline (Day 0) 34.4  (28.6) 34.0  (28.0) 34.2  (28.2) 30.8  (26.4) 32.6  (27.6) 31.7  (27.0)
Immediately Post-Treatment (Day 0) 25.2  (25.1) 23.6  (23.7) 24.4  (24.3) 10.2  (14.6) 10.1  (13.8) 10.1  (14.1)
Day 1 Post-Treatment 12.0  (15.7) 13.0  (17.0) 12.5  (16.3) 11.8  (17.8) 11.5  (16.9) 11.7  (17.3)
6.Secondary Outcome
Title Mean Discomfort Score During Treatment
Hide Description The patient placed a vertical line on visual analog scale questionnaire using a scale of 0-100 (0 = no discomfort, 100 = maximum discomfort) at the point that indicated the discomfort in or around their eyelids, or face during the procedure including feelings of pressure, tightness, heaviness, burning, and other negative sensations. Assessments were made at baseline (pre-treatment), immediately post-treatment, and Day 1 post-treatment. No formal hypothesis testing was pre-specified for this endpoint.
Time Frame Baseline (Day 0), Immediately Post-Treatment (Day 0), Day 1 Post-Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized and treated patients
Arm/Group Title iLux Right Eye iLux Left Eye iLux Both Eyes LipiFlow Right Eye LipiFlow Left Eye LipiFlow Both Eyes
Hide Arm/Group Description:
Right Eye of Subjects treated with the iLux 2020 System
Left Eye of Subjects treated with the iLux 2020 System
Both Eyes of Subjects treated with the iLux 2020 System
Right Eye of Subjects Treated with the LipiFlow Thermal Pulsation System
Left Eye of Subjects treated with Lipiflow Thermal Pulsation System
Both Eyes of Subjects treated with the LipiFlow Thermal Pulsation System
Overall Number of Participants Analyzed 71 71 71 69 70 70
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
71 71 142 69 70 139
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline (Day 0) 56.3  (22.3) 55.9  (21.8) 56.1  (22.0) 52.1  (23.6) 52.6  (24.0) 52.3  (23.6)
Immediately Post-Treatment (Day 0) 38.9  (24.7) 36.7  (22.5) 37.8  (23.6) 22.3  (21.2) 23.7  (21.6) 23.0  (21.3)
Day 1 Post-Treatment 23.5  (22.5) 23.7  (22.4) 23.6  (22.4) 24.7  (24.2) 24.4  (23.4) 24.5  (23.7)
7.Secondary Outcome
Title Change From Baseline to Post-Treatment in Ocular Surface Staining
Hide Description Corneal staining was assessed by the examiner using the National Eye Institute corneal grading scale and a slit-lamp. Each of the 5 corneal regions (superior, inferior, central, temporal, & central), was graded on a 0-3 scale, where 0=normal-no staining (best); 1=mild-superficial stippling micropunctate staining; 2=moderate-macropunctate staining with some coalescent areas; and 3=severe-numerous coalescent macropunctate areas and/or patches (worst). The scores were summed for each eye, and an overall corneal staining score was computed as the average of the sum from both eyes. Overall scores ranged between 0-15, with higher change value indicating greater damage to the corneal surface. Assessments were made at baseline (pre-treatment), immediately post-treatment, and Day 1 post-treatment. No formal hypothesis testing was pre-specified for this endpoint.
Time Frame Baseline (Day 0), Immediately Post-Treatment (Day 0), Day 1 Post-Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title iLux Right Eye iLux Left Eye iLux Both Eyes LipiFlow Right Eye LipiFlow Left Eye LipiFlow Both Eyes
Hide Arm/Group Description:
Right Eye of Subjects treated with the iLux 2020 System
Left Eye of Subjects treated with the iLux 2020 System
Both Eyes of Subjects treated with the iLux 2020 System
Right Eye of Subjects Treated with the LipiFlow Thermal Pulsation System
Left Eye of Subjects treated with Lipiflow Thermal Pulsation System
Both Eyes of Subjects treated with the LipiFlow Thermal Pulsation System
Overall Number of Participants Analyzed 71 71 71 70 70 70
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
71 71 142 70 70 140
Mean (Standard Deviation)
Unit of Measure: score on a scale
Change from Baseline to Immediately Post-Treatment 0.6  (1.7) 0.6  (1.7) 0.6  (1.7) 0.5  (1.6) 0.4  (1.5) 0.4  (1.6)
Change from Baseline to Day 1 Post-Treatment -0.9  (1.8) -1.0  (2.0) -0.9  (1.9) -0.9  (1.5) -1.2  (1.9) -1.1  (1.7)
8.Secondary Outcome
Title Change From Baseline to Post-Treatment in Intraocular Pressure (IOP)
Hide Description IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A negative change value indicates an improvement. No formal hypothesis testing was pre-specified for this endpoint.
Time Frame Baseline (Day 0), Immediately Post-Treatment (Day 0)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized and treated patients
Arm/Group Title iLux Right Eye iLux Left Eye iLux Both Eyes LipiFlow Right Eye LipiFlow Left Eye LipiFlow Both Eyes
Hide Arm/Group Description:
Right Eye of Subjects treated with the iLux 2020 System
Left Eye of Subjects treated with the iLux 2020 System
Both Eyes of Subjects treated with the iLux 2020 System
Right Eye of Subjects Treated with the LipiFlow Thermal Pulsation System
Left Eye of Subjects treated with Lipiflow Thermal Pulsation System
Both Eyes of Subjects treated with the LipiFlow Thermal Pulsation System
Overall Number of Participants Analyzed 71 71 71 69 69 69
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
71 71 142 69 69 138
Mean (Standard Deviation)
Unit of Measure: mmHg
0.04  (1.44) -0.07  (1.54) -0.01  (1.49) 0.07  (1.94) -0.04  (1.79) 0.01  (1.86)
9.Secondary Outcome
Title Change From Baseline to Post-Treatment in Best Spectacle-Corrected Visual Acuity (BSCVA)
Hide Description Visual acuity was assessed with spectacles or other visual corrective devices in place using Early Treatment Diabetic Retinopathy Study (ETDRS) charts. Results are presented in logarithm of the minimum angle of resolution (logMAR) with 0.2 in logMAR corresponding to 10 ETDRS letters read. A lower logMAR change value indicates an improvement in visual acuity. No formal hypothesis testing was pre-specified for this endpoint.
Time Frame Baseline (Day 0), Immediately Post-Treatment (Day 0)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized and treated patients
Arm/Group Title iLux Right Eye iLux Left Eye iLux Both Eyes LipiFlow Right Eye LipiFlow Left Eye LipiFlow Both Eyes
Hide Arm/Group Description:
Right Eye of Subjects treated with the iLux 2020 System
Left Eye of Subjects treated with the iLux 2020 System
Both Eyes of Subjects treated with the iLux 2020 System
Right Eye of Subjects Treated with the LipiFlow Thermal Pulsation System
Left Eye of Subjects treated with Lipiflow Thermal Pulsation System
Both Eyes of Subjects treated with the LipiFlow Thermal Pulsation System
Overall Number of Participants Analyzed 71 71 71 70 70 70
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
71 71 142 70 70 140
Mean (Standard Deviation)
Unit of Measure: logMAR
0.02  (0.08) 0.05  (0.11) 0.03  (0.09) 0.02  (0.11) 0.02  (0.07) 0.02  (0.09)
Time Frame 4 weeks
Adverse Event Reporting Description Any untoward and unintended sign, symptom or disease temporally associated with the use of an investigational drug or device, or other protocol-imposed intervention, regardless of the suspected cause. Chronic but stable conditions or diseases are not AEs. Changes in a chronic condition or disease consistent with natural disease progression are not AEs. AEs were assessed during procedure, immediately post-procedure, 1 day, 2 weeks, & 4 weeks post-procedure.
 
Arm/Group Title iLux 2020 System LipiFlow Thermal Pulsation System
Hide Arm/Group Description

Meibomian Gland Treatment

iLux 2020 System: Heating and compression to express clogged meibomian glands

Meibomian Gland Treatment

LipiFlow Pulsation System: Heating and compression to express clogged meibomian glands

All-Cause Mortality
iLux 2020 System LipiFlow Thermal Pulsation System
Affected / at Risk (%) Affected / at Risk (%)
Total   0/71 (0.00%)      0/71 (0.00%)    
Hide Serious Adverse Events
iLux 2020 System LipiFlow Thermal Pulsation System
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/71 (0.00%)      0/71 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
iLux 2020 System LipiFlow Thermal Pulsation System
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/71 (7.04%)      4/71 (5.63%)    
Eye disorders     
Other  [1]  5/71 (7.04%)  5 4/71 (5.63%)  4
Indicates events were collected by systematic assessment
[1]
Includes: burning sensation, itching, stinging, petechial hemorrhage, superficial punctate keratitis, and blurred vision
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Rob Thornhill
Organization: TearFilm Innovations, Inc.
Phone: 844-458-9776
EMail: rthornhill@tearfilm.com
Layout table for additonal information
Responsible Party: Tear Film Innovations, Inc.
ClinicalTrials.gov Identifier: NCT03055832    
Other Study ID Numbers: 2020-03
First Submitted: February 10, 2017
First Posted: February 16, 2017
Results First Submitted: April 22, 2019
Results First Posted: May 20, 2019
Last Update Posted: May 30, 2019