Trial Outcomes & Findings for Treatment of Meibomian Gland Dysfunction Prior to Cataract Surgery (NCT NCT01808560)
NCT ID: NCT01808560
Last Updated: 2018-09-04
Results Overview
The primary endpoint is the mean change in total meibomian gland score in the Pre-treatment group compared to the Untreated group from Baseline after cataract surgery. Meibomian gland assessment was performed to evaluate the function of the meibomian glands based on the secretion characteristics from the gland orifices along the lower eyelid. Under a slit-lamp biomicrosope, the gland orifices were evaluated using a handheld instrument, Meibomian Gland Evaluator. This instrument provided a standardized method of applying the same amount of pressure and for each eye to ensure measurement consistency. A total of 15 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 of 0 to 45.
COMPLETED
NA
34 participants
Baseline and 3 Months post-surgery
2018-09-04
Participant Flow
Participant milestones
| Measure |
LipiFlow Pre-treatment
Subjects randomized to the LipiFlow Pre-Treatment group receive a 12-minute LipiFlow System treatment for MGD in both eyes one month prior to cataract surgery.
LipiFlow Pre-Treatment: The LipiFlow Thermal Pulsation System is 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 randomized to the untreated control group receive no MGD treatment prior to cataract surgery.
|
LipiFlow Post-treatment
Subjects in the untreated control group receive a 12-minute crossover treatment with the LipiFlow System in both eyes three months after cataract surgery.
LipiFlow Post-treatment: The LipiFlow Thermal Pulsation System is 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.
|
|---|---|---|---|
|
Randomization and Treatment Allocation
STARTED
|
18
|
16
|
0
|
|
Randomization and Treatment Allocation
COMPLETED
|
18
|
16
|
0
|
|
Randomization and Treatment Allocation
NOT COMPLETED
|
0
|
0
|
0
|
|
1-Month After Cataract Surgery
STARTED
|
16
|
13
|
0
|
|
1-Month After Cataract Surgery
COMPLETED
|
16
|
13
|
0
|
|
1-Month After Cataract Surgery
NOT COMPLETED
|
0
|
0
|
0
|
|
3-Month After Cataract Surgery
STARTED
|
17
|
13
|
0
|
|
3-Month After Cataract Surgery
COMPLETED
|
17
|
13
|
0
|
|
3-Month After Cataract Surgery
NOT COMPLETED
|
0
|
0
|
0
|
|
Crossover Treatment
STARTED
|
0
|
0
|
13
|
|
Crossover Treatment
COMPLETED
|
0
|
0
|
13
|
|
Crossover Treatment
NOT COMPLETED
|
0
|
0
|
0
|
|
4-Month After Cataract Surgery
STARTED
|
0
|
0
|
13
|
|
4-Month After Cataract Surgery
COMPLETED
|
0
|
0
|
13
|
|
4-Month After Cataract Surgery
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment of Meibomian Gland Dysfunction Prior to Cataract Surgery
Baseline characteristics by cohort
| Measure |
LipiFlow Pre-treatment
n=18 Participants
Subjects randomized to the LipiFlow Pre-Treatment group receive a 12-minute LipiFlow System treatment for MGD in both eyes one month prior to cataract surgery.
LipiFlow Pre-Treatment: The LipiFlow Thermal Pulsation System is 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
n=16 Participants
Subjects randomized to the untreated control group receive no MGD treatment prior to cataract surgery.
|
LipiFlow Post-treatment
Subjects in the untreated control group receive a 12-minute crossover treatment with the LipiFlow System in both eyes three months after cataract surgery.
LipiFlow Post-treatment: The LipiFlow Thermal Pulsation System is 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.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
71.9 years
STANDARD_DEVIATION 5.7 • n=93 Participants
|
68.6 years
STANDARD_DEVIATION 6.4 • n=4 Participants
|
—
|
70.4 years
STANDARD_DEVIATION 6.2 • n=483 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
—
|
25 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
—
|
9 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
—
|
1 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
—
|
33 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
—
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
—
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
—
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
—
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
—
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
—
|
32 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
—
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
—
|
0 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Baseline and 3 Months post-surgeryPopulation: Intent to Treat (ITT) Population of all randomized subjects.
The primary endpoint is the mean change in total meibomian gland score in the Pre-treatment group compared to the Untreated group from Baseline after cataract surgery. Meibomian gland assessment was performed to evaluate the function of the meibomian glands based on the secretion characteristics from the gland orifices along the lower eyelid. Under a slit-lamp biomicrosope, the gland orifices were evaluated using a handheld instrument, Meibomian Gland Evaluator. This instrument provided a standardized method of applying the same amount of pressure and for each eye to ensure measurement consistency. A total of 15 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 of 0 to 45.
Outcome measures
| Measure |
LipiFlow Pre-treatment
n=34 Eyes
Subjects randomized to the LipiFlow Pre-Treatment group receive a 12-minute LipiFlow System treatment for MGD in both eyes one month prior to cataract surgery.
LipiFlow Pre-Treatment: The LipiFlow Thermal Pulsation System is 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
n=26 Eyes
Subjects randomized to the untreated control group receive no MGD treatment prior to cataract surgery.
|
LipiFlow Post-treatment
Subjects in the untreated control group receive a 12-minute crossover treatment with the LipiFlow System in both eyes three months after cataract surgery.
LipiFlow Post-treatment: The LipiFlow Thermal Pulsation System is 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.
|
|---|---|---|---|
|
Mean Change in Total Meibomian Gland Score
|
12.8 Change in Meibomian Gland Score
Standard Deviation 9.9
|
1.9 Change in Meibomian Gland Score
Standard Deviation 6.1
|
—
|
SECONDARY outcome
Timeframe: Baseline and 3 Months post-surgeryPopulation: Intent to Treat (ITT) Population of all randomized subjects.
Assess for reduction in dry eye symptoms in symptomatic contact lens after LipiFlow treatment in comparison to an untreated control using Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire. It was defined as the mean change in SPEED score in the LF Treatment group compared to Control group from Baseline to 3 Months. The symptoms assessed are dryness, grittiness / scratchiness; soreness / irritation; burning / watering; and eye fatigue. Symptom frequency is on a scale of: 0 (never), 1(sometimes), 2 (often) and 3 (constant). Symptom severity is on a scale of: 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 calculated as sum of frequency and severity scores for symptoms over a range from 0 to 28. A lower SPEED score represents less frequent and/or less severe symptoms.
Outcome measures
| Measure |
LipiFlow Pre-treatment
n=17 Participants
Subjects randomized to the LipiFlow Pre-Treatment group receive a 12-minute LipiFlow System treatment for MGD in both eyes one month prior to cataract surgery.
LipiFlow Pre-Treatment: The LipiFlow Thermal Pulsation System is 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
n=13 Participants
Subjects randomized to the untreated control group receive no MGD treatment prior to cataract surgery.
|
LipiFlow Post-treatment
Subjects in the untreated control group receive a 12-minute crossover treatment with the LipiFlow System in both eyes three months after cataract surgery.
LipiFlow Post-treatment: The LipiFlow Thermal Pulsation System is 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.
|
|---|---|---|---|
|
Mean Change in Dry Eye Questionnaire Score From Baseline at 3 Months
|
-3.4 Change in SPEED Score
Standard Deviation 5.7
|
1.2 Change in SPEED Score
Standard Deviation 5.4
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 3 Months post-surgeryPopulation: Intent to Treat (ITT) Population of all randomized subjects.
Dry eye symptoms assessed using the OSDI questionnaire are sensitivity to light, grittiness, pain or soreness, blurred vision and poor vision. The assessment considers the frequency that problems with the eyes limit performance in reading, driving at night, working with a computer or bank machine, and watching television. Also, the frequency that eyes feel uncomfortable is assessed in windy conditions, areas with low humidity, and air-conditioned areas. The frequency scale is: 0 (none of the time), 1 (some of the time), 2 (half of the time), 3 (most of the time) and 4 (all of the time). The subject can answer not applicable (N/A) if the subject did not experience the situation or condition in the past week. Total OSDI score is calculated as the sum of frequency scores for all symptoms multiplied by 25 and divided by the number of questions answered with a range from 0 to 100. A lower OSDI score represents less disability from dry eye symptoms.
Outcome measures
| Measure |
LipiFlow Pre-treatment
n=17 Participants
Subjects randomized to the LipiFlow Pre-Treatment group receive a 12-minute LipiFlow System treatment for MGD in both eyes one month prior to cataract surgery.
LipiFlow Pre-Treatment: The LipiFlow Thermal Pulsation System is 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
n=13 Participants
Subjects randomized to the untreated control group receive no MGD treatment prior to cataract surgery.
|
LipiFlow Post-treatment
Subjects in the untreated control group receive a 12-minute crossover treatment with the LipiFlow System in both eyes three months after cataract surgery.
LipiFlow Post-treatment: The LipiFlow Thermal Pulsation System is 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.
|
|---|---|---|---|
|
Mean Change in Ocular Surface Disease Index (OSDI) Questionnaire Score From Baseline at 3 Months
|
-8.7 Change in Total OSDI Score
Standard Deviation 22.3
|
2.0 Change in Total OSDI Score
Standard Deviation 17.2
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 3 Months post-surgeryPopulation: Intent to Treat (ITT) Population of all randomized subjects.
The National Eye Institute Visual Function Questionnaire (NEI-VFQ) evaluates frequency or severity of a symptoms and the effect on activities of daily living. The questionnaire has an overall score and 12 subscale scores for general health, general vision, ocular pain, difficulty with near vision activities, difficulty with distance vision activities, social functioning limitations due to vision, mental functioning limitations due to vision, role limitations due to vision, dependency on others due to vision, driving difficulties, color vision and peripheral vision. The NEI-VFQ scores range from 0 to 100 with lower scores indicating more symptoms or difficulty with activities of daily living. The questionnaire is scored by recoding responses to set values on a 0 to 100 scale such that the lowest value is set to 0 and the highest value is set to 100. The overall score is the average of vision subscale scores, excluding general health question.
Outcome measures
| Measure |
LipiFlow Pre-treatment
n=17 Participants
Subjects randomized to the LipiFlow Pre-Treatment group receive a 12-minute LipiFlow System treatment for MGD in both eyes one month prior to cataract surgery.
LipiFlow Pre-Treatment: The LipiFlow Thermal Pulsation System is 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
n=13 Participants
Subjects randomized to the untreated control group receive no MGD treatment prior to cataract surgery.
|
LipiFlow Post-treatment
Subjects in the untreated control group receive a 12-minute crossover treatment with the LipiFlow System in both eyes three months after cataract surgery.
LipiFlow Post-treatment: The LipiFlow Thermal Pulsation System is 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.
|
|---|---|---|---|
|
Mean Change in NEI-VFQ Questionnaire Score From Baseline at 3 Months
|
11.6 Change in NEI-VFQ-25 Composite Score
Standard Deviation 14.1
|
7.3 Change in NEI-VFQ-25 Composite Score
Standard Deviation 10.8
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 3 Months post-surgeryPopulation: Intent to Treat (ITT) Population of all randomized subjects.
Meibomian gland assessment was performed to evaluate the function of the meibomian glands based on the secretion characteristics from the gland orifices along the lower eyelid at the visits. Under a slit-lamp biomicrosope, the gland orifices were evaluated using a handheld instrument, Meibomian Gland Evaluator, to apply gentle pressure along the eyelid margin. This instrument provided a standardized method of applying the same amount of pressure at each visit and for each eye to ensure measurement consistency. The number of meibomian glands yielding liquid secretion (MGYLS) (i.e., cloudy or clear liquid with a grade of 2 or 3) was counted out of the 15 glands assessed with a range of 0 to 15. A higher total meibomian gland score or higher number of MGYLS reflects less meibomian gland dysfunction.
Outcome measures
| Measure |
LipiFlow Pre-treatment
n=17 Participants
Subjects randomized to the LipiFlow Pre-Treatment group receive a 12-minute LipiFlow System treatment for MGD in both eyes one month prior to cataract surgery.
LipiFlow Pre-Treatment: The LipiFlow Thermal Pulsation System is 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
n=13 Participants
Subjects randomized to the untreated control group receive no MGD treatment prior to cataract surgery.
|
LipiFlow Post-treatment
Subjects in the untreated control group receive a 12-minute crossover treatment with the LipiFlow System in both eyes three months after cataract surgery.
LipiFlow Post-treatment: The LipiFlow Thermal Pulsation System is 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.
|
|---|---|---|---|
|
Mean Change in Number of MGYLS (Meibomian Glands Yielding Liquid Secretion)
|
5.6 Change in Number of MGYLS
Standard Deviation 4.8
|
1.0 Change in Number of MGYLS
Standard Deviation 3.1
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 3 Months post-surgeryPopulation: Intent to Treat (ITT) Population of all randomized subjects.
The Investigator or designee measures tear break-up time (TBUT) under a slit-lamp biomicroscope following instillation of fluorescein dye in the eye using the Dry Eye Test (DET) method. Tear film break-up is defined as the first observed break-up of the tear film following the third blink. Using a stopwatch to record the time, start the stopwatch as soon as the subject opens his/her eyes after the third blink and stop the stopwatch when the first break-up of the tear film is observed. Any values recorded as greater than 20 seconds were converted to 20 seconds in the analysis. Three separate measurements were taken for each eye and were averaged for analysis. A higher tear break-up time indicates better tear film stability.
Outcome measures
| Measure |
LipiFlow Pre-treatment
n=34 Eyes
Subjects randomized to the LipiFlow Pre-Treatment group receive a 12-minute LipiFlow System treatment for MGD in both eyes one month prior to cataract surgery.
LipiFlow Pre-Treatment: The LipiFlow Thermal Pulsation System is 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
n=26 Eyes
Subjects randomized to the untreated control group receive no MGD treatment prior to cataract surgery.
|
LipiFlow Post-treatment
Subjects in the untreated control group receive a 12-minute crossover treatment with the LipiFlow System in both eyes three months after cataract surgery.
LipiFlow Post-treatment: The LipiFlow Thermal Pulsation System is 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.
|
|---|---|---|---|
|
Mean Change in Tear Break-up Time (TBUT)
|
1.4 Change in TBUT (in seconds)
Standard Deviation 5.2
|
-0.6 Change in TBUT (in seconds)
Standard Deviation 3.0
|
—
|
Adverse Events
LipiFlow Pre-treatment
Untreated Control
LipiFlow Post-treatment
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Manager of Clinical and Medical Affairs
TearScience, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER