Trial Outcomes & Findings for Randomized Controlled Trial of Long-term Treatment Effectiveness for Meibomian Gland Dysfunction (MGD) and Dry Eye (NCT NCT01521507)
NCT ID: NCT01521507
Last Updated: 2015-02-23
Results Overview
To assess the meibomian glands, the secretion characteristics from 15 gland orifices along the lower eyelid were evaluated under a slit lamp biomicrosope using a handheld instrument, Meibomian Gland Evaluator, to apply gentle standardized pressure to the eyelid margin. Expressed secretion characteristics were graded on a scale of 3 (clear liquid secretion), 2 (cloudy liquid secretion), 1 (inspissated/toothpaste consistency), and 0 (no secretion). Total meibomian gland score was calculated based on the sum of the secretion grades for all 15 glands over a range from 0 to 45 with a higher score reflecting less meibomian gland dysfunction. To be eligible for the study, the Baseline total meibomian gland score must have been 12 or less in each eye. Change = 3 Month score - Baseline Score.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
200 participants
Primary outcome timeframe
Baseline and 3 Months
Results posted on
2015-02-23
Participant Flow
Between February 19, 2012 and October 15, 2012, this study enrolled subjects with meibomian gland dysfunction (MGD) and evaporative dry eye from nine ophthalmic practices in the United States.
A total of 274 subjects were consented and 200 subjects were randomized. Of the 74 subjects who were not randomized, 52 subjects did not meet the study eligibility criteria and 22 subjects elected not to participate prior to randomization or had not yet attended the Baseline visit when study enrollment was completed.
Participant milestones
| Measure |
LipiFlow Treatment
Subjects received a single, 12-minute, in-office treatment of both eyes for MGD with the LipiFlow System after randomization in Stage 1 of study.
In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief:
1. One LipiFlow Treatment - After subjects received one LipiFlow treatment at randomization, no other MGD or dry eye treatment was prescribed for the study duration.
2. Two LipiFlow Treatments - Subjects received a second LipiFlow treatment during Stage 2. No other MGD or dry eye treatment was prescribed for the study duration.
3. Combination Treatment - After subjects received one or two LipiFlow treatments, they received other MGD or dry eye treatment, as prescribed by the physician.
|
Warm Compress & Lid Hygiene, Then Crossover LipiFlow Treatment
Subjects received twice-daily, standardized warm compress therapy and lid hygiene in both eyes from randomization to 3 months in Stage 1. Then, subjects received a single, 12-minute crossover LipiFlow treatment of both eyes.
In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief:
1. One LipiFlow Treatment - After subjects received one LipiFlow treatment at crossover, no other MGD or dry eye treatment was prescribed for the study duration.
2. Two LipiFlow Treatments - Subjects received a second LipiFlow treatment during Stage 2. No other MGD or dry eye treatment was prescribed for the study duration.
3. Combination Treatment - After subjects received one or two LipiFlow treatments, they received other MGD or dry eye treatment, as prescribed by the physician.
|
|---|---|---|
|
Stage 1: Randomized Design
STARTED
|
101
|
99
|
|
Stage 1: Randomized Design
Received Initial Treatment (Tx)
|
99
|
98
|
|
Stage 1: Randomized Design
COMPLETED
|
98
|
94
|
|
Stage 1: Randomized Design
NOT COMPLETED
|
3
|
5
|
|
Stage 2: Observational Design
STARTED
|
98
|
94
|
|
Stage 2: Observational Design
Received Crossover LipiFlow Tx
|
0
|
93
|
|
Stage 2: Observational Design
Received Only One LipiFlow Tx at 12 Mo
|
81
|
82
|
|
Stage 2: Observational Design
Received Other MGD Treatment at 12 Mo
|
11
|
9
|
|
Stage 2: Observational Design
Received 2nd LipiFlow Tx at 12 Mo
|
2
|
1
|
|
Stage 2: Observational Design
COMPLETED
|
94
|
92
|
|
Stage 2: Observational Design
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
LipiFlow Treatment
Subjects received a single, 12-minute, in-office treatment of both eyes for MGD with the LipiFlow System after randomization in Stage 1 of study.
In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief:
1. One LipiFlow Treatment - After subjects received one LipiFlow treatment at randomization, no other MGD or dry eye treatment was prescribed for the study duration.
2. Two LipiFlow Treatments - Subjects received a second LipiFlow treatment during Stage 2. No other MGD or dry eye treatment was prescribed for the study duration.
3. Combination Treatment - After subjects received one or two LipiFlow treatments, they received other MGD or dry eye treatment, as prescribed by the physician.
|
Warm Compress & Lid Hygiene, Then Crossover LipiFlow Treatment
Subjects received twice-daily, standardized warm compress therapy and lid hygiene in both eyes from randomization to 3 months in Stage 1. Then, subjects received a single, 12-minute crossover LipiFlow treatment of both eyes.
In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief:
1. One LipiFlow Treatment - After subjects received one LipiFlow treatment at crossover, no other MGD or dry eye treatment was prescribed for the study duration.
2. Two LipiFlow Treatments - Subjects received a second LipiFlow treatment during Stage 2. No other MGD or dry eye treatment was prescribed for the study duration.
3. Combination Treatment - After subjects received one or two LipiFlow treatments, they received other MGD or dry eye treatment, as prescribed by the physician.
|
|---|---|---|
|
Stage 1: Randomized Design
Device did not fit, No Treatment
|
2
|
0
|
|
Stage 1: Randomized Design
Withdrawal by Subject
|
1
|
3
|
|
Stage 1: Randomized Design
Lost to Follow-up
|
0
|
2
|
|
Stage 2: Observational Design
Device did not fit, No Treatment
|
0
|
1
|
|
Stage 2: Observational Design
Withdrawal by Subject
|
3
|
1
|
|
Stage 2: Observational Design
Physician Decision
|
1
|
0
|
Baseline Characteristics
Randomized Controlled Trial of Long-term Treatment Effectiveness for Meibomian Gland Dysfunction (MGD) and Dry Eye
Baseline characteristics by cohort
| Measure |
LipiFlow Treatment
n=101 Participants
Subjects received a single, 12-minute, in-office treatment of both eyes for MGD with the LipiFlow System after randomization in Stage 1 of study.
|
Warm Compress & Lid Hygiene
n=99 Participants
Subjects received twice-daily, standardized warm compress therapy and lid hygiene in both eyes from randomization to 3-month visit in Stage 1.
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.3 years
STANDARD_DEVIATION 15.9 • n=99 Participants
|
56.1 years
STANDARD_DEVIATION 14.7 • n=107 Participants
|
56.2 years
STANDARD_DEVIATION 15.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
74 Participants
n=99 Participants
|
68 Participants
n=107 Participants
|
142 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
94 Participants
n=99 Participants
|
92 Participants
n=107 Participants
|
186 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
98 Participants
n=99 Participants
|
96 Participants
n=107 Participants
|
194 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
101 participants
n=99 Participants
|
99 participants
n=107 Participants
|
200 participants
n=206 Participants
|
|
Baseline Total Meibomian Gland Score
|
6.2 units on a scale
STANDARD_DEVIATION 3.7 • n=99 Participants
|
6.3 units on a scale
STANDARD_DEVIATION 3.7 • n=107 Participants
|
6.2 units on a scale
STANDARD_DEVIATION 3.7 • n=206 Participants
|
|
Baseline Total OSDI Score
|
45.6 units on a scale
STANDARD_DEVIATION 21.2 • n=99 Participants
|
51.8 units on a scale
STANDARD_DEVIATION 23.1 • n=107 Participants
|
48.7 units on a scale
STANDARD_DEVIATION 22.4 • n=206 Participants
|
|
Duration of Dry Eye Symptoms
|
6.9 years
STANDARD_DEVIATION 6.8 • n=99 Participants
|
8.7 years
STANDARD_DEVIATION 7.7 • n=107 Participants
|
7.8 years
STANDARD_DEVIATION 7.3 • n=206 Participants
|
|
Duration of MGD or Dry Eye Diagnosis
|
5.3 years
STANDARD_DEVIATION 6.2 • n=99 Participants
|
5.5 years
STANDARD_DEVIATION 5.9 • n=107 Participants
|
5.4 years
STANDARD_DEVIATION 6.0 • n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and 3 MonthsPopulation: Intent to Treat Population (All Participants who were randomized and received at least partial LipiFlow treatment or used warm compress therapy at least once and had data available at 3 Months).
To assess the meibomian glands, the secretion characteristics from 15 gland orifices along the lower eyelid were evaluated under a slit lamp biomicrosope using a handheld instrument, Meibomian Gland Evaluator, to apply gentle standardized pressure to the eyelid margin. Expressed secretion characteristics were graded on a scale of 3 (clear liquid secretion), 2 (cloudy liquid secretion), 1 (inspissated/toothpaste consistency), and 0 (no secretion). Total meibomian gland score was calculated based on the sum of the secretion grades for all 15 glands over a range from 0 to 45 with a higher score reflecting less meibomian gland dysfunction. To be eligible for the study, the Baseline total meibomian gland score must have been 12 or less in each eye. Change = 3 Month score - Baseline Score.
Outcome measures
| Measure |
LipiFlow Treatment
n=98 Participants
Subjects received a single, 12-minute, in-office treatment of both eyes for MGD with the LipiFlow System after randomization in Stage 1 of study.
|
Warm Compress & Lid Hygiene
n=94 Participants
Subjects received twice-daily, standardized warm compress therapy and lid hygiene in both eyes from randomization to 3-month visit in Stage 1.
|
Warm Compress/Hygiene Arm: One LipiFlow Treatment Subgroup
After 3 months of using standardized warm compress therapy and lid hygiene, subjects received a single, 12-minute crossover LipiFlow treatment of both eyes.
In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief. In the One LipiFlow Treatment subgroup, no other MGD or dry eye treatment was prescribed for the study duration.
|
Warm Compress/Hygiene Arm: Combination Treatment Subgroup
After 3 months of using standardized warm compress therapy and lid hygiene, subjects received a single, 12-minute crossover LipiFlow treatment of both eyes.
In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief. In the Combination Treatment subgroup, subjects received one LipiFlow treatment (at crossover) or two LipiFlow treatments followed by other MGD or dry eye treatment, as prescribed by the physician.
|
|---|---|---|---|---|
|
Stage 1 Mean Change in Total Meibomian Gland Score From Baseline to 3 Months
|
11.6 units on a scale
Interval 10.2 to 13.0
|
4.5 units on a scale
Interval 3.4 to 5.6
|
—
|
—
|
PRIMARY outcome
Timeframe: 12 MonthsPopulation: Intent to Treat Population (All participants who received at least partial LipiFlow or Crossover LipiFlow treatment and had data available at 12 Months). Two LipiFlow treatments subgroup was not analyzed because sample size was too small (n\<5) for meaningful analysis.
To assess the meibomian glands, the secretion characteristics from 15 gland orifices along the lower eyelid were evaluated under a slit lamp biomicrosope using a handheld instrument, Meibomian Gland Evaluator, to apply gentle standardized pressure to the eyelid margin. Expressed secretion characteristics were graded on a scale of 3 (clear liquid secretion), 2 (cloudy liquid secretion), 1 (inspissated/toothpaste consistency), and 0 (no secretion). Total meibomian gland score was calculated based on the sum of the secretion grades for all 15 glands over a range from 0 to 45 with a higher score reflecting less meibomian gland dysfunction. The total meibomian gland score at 12 Months was compared across subgroups, as defined below.
Outcome measures
| Measure |
LipiFlow Treatment
n=81 Participants
Subjects received a single, 12-minute, in-office treatment of both eyes for MGD with the LipiFlow System after randomization in Stage 1 of study.
|
Warm Compress & Lid Hygiene
n=11 Participants
Subjects received twice-daily, standardized warm compress therapy and lid hygiene in both eyes from randomization to 3-month visit in Stage 1.
|
Warm Compress/Hygiene Arm: One LipiFlow Treatment Subgroup
n=82 Participants
After 3 months of using standardized warm compress therapy and lid hygiene, subjects received a single, 12-minute crossover LipiFlow treatment of both eyes.
In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief. In the One LipiFlow Treatment subgroup, no other MGD or dry eye treatment was prescribed for the study duration.
|
Warm Compress/Hygiene Arm: Combination Treatment Subgroup
n=9 Participants
After 3 months of using standardized warm compress therapy and lid hygiene, subjects received a single, 12-minute crossover LipiFlow treatment of both eyes.
In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief. In the Combination Treatment subgroup, subjects received one LipiFlow treatment (at crossover) or two LipiFlow treatments followed by other MGD or dry eye treatment, as prescribed by the physician.
|
|---|---|---|---|---|
|
Stage 2 Mean Total Meibomian Gland Score at 12 Months
|
17.3 units on a scale
Interval 15.8 to 18.7
|
17.9 units on a scale
Interval 13.1 to 22.7
|
18.4 units on a scale
Interval 16.7 to 20.1
|
17.4 units on a scale
Interval 13.2 to 21.6
|
SECONDARY outcome
Timeframe: Baseline, 3 MonthsPopulation: Intent to Treat Population (All participants who were randomized and received at least partial device treatment or used warm compress at least once and had data available at 3 Months).
Dry eye symptoms assessed using the OSDI questionnaire were sensitivity to light, grittiness, pain or soreness, blurred vision and poor vision. The questionnaire evaluated the frequency problems with the eyes limited performance in reading, driving at night, working with a computer or bank machine, and watching television. Also, the frequency that eyes felt uncomfortable was assessed in windy conditions, areas with low humidity, and air-conditioned areas. The frequency scale was 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 total OSDI score was 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 total OSDI score represents less disability from dry eye symptoms. To be eligible for the study, the Baseline total OSDI score must have been 13 points or higher in each eye. Change=3 Months score-Baseline score.
Outcome measures
| Measure |
LipiFlow Treatment
n=98 Participants
Subjects received a single, 12-minute, in-office treatment of both eyes for MGD with the LipiFlow System after randomization in Stage 1 of study.
|
Warm Compress & Lid Hygiene
n=94 Participants
Subjects received twice-daily, standardized warm compress therapy and lid hygiene in both eyes from randomization to 3-month visit in Stage 1.
|
Warm Compress/Hygiene Arm: One LipiFlow Treatment Subgroup
After 3 months of using standardized warm compress therapy and lid hygiene, subjects received a single, 12-minute crossover LipiFlow treatment of both eyes.
In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief. In the One LipiFlow Treatment subgroup, no other MGD or dry eye treatment was prescribed for the study duration.
|
Warm Compress/Hygiene Arm: Combination Treatment Subgroup
After 3 months of using standardized warm compress therapy and lid hygiene, subjects received a single, 12-minute crossover LipiFlow treatment of both eyes.
In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief. In the Combination Treatment subgroup, subjects received one LipiFlow treatment (at crossover) or two LipiFlow treatments followed by other MGD or dry eye treatment, as prescribed by the physician.
|
|---|---|---|---|---|
|
Stage 1 Mean Change in Total OSDI Score From Baseline to 3 Months
|
-23.4 units on a scale
Interval -26.3 to -20.5
|
-17.8 units on a scale
Interval -20.7 to -14.9
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: Intent to Treat (All participants who received at least a partial LipiFlow treatment or Crossover LipiFlow treatment and had data available at 12 Months). The Two LipiFlow treatments subgroup was not analyzed because the sample size (n\<5) was too small for meaningful analysis.
Dry eye symptoms assessed using the OSDI questionnaire were sensitivity to light, grittiness, pain or soreness, blurred vision and poor vision. The questionnaire evaluated the frequency problems with the eyes limited performance in reading, driving at night, working with a computer or bank machine, and watching television. Also, the frequency that eyes felt uncomfortable was assessed in windy conditions, areas with low humidity, and air-conditioned areas. Frequency scale was 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 total OSDI score was 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 total OSDI score represents less disability from dry eye symptoms. The total OSDI score at 12 Months was compared across subgroups, as defined below.
Outcome measures
| Measure |
LipiFlow Treatment
n=81 Participants
Subjects received a single, 12-minute, in-office treatment of both eyes for MGD with the LipiFlow System after randomization in Stage 1 of study.
|
Warm Compress & Lid Hygiene
n=11 Participants
Subjects received twice-daily, standardized warm compress therapy and lid hygiene in both eyes from randomization to 3-month visit in Stage 1.
|
Warm Compress/Hygiene Arm: One LipiFlow Treatment Subgroup
n=82 Participants
After 3 months of using standardized warm compress therapy and lid hygiene, subjects received a single, 12-minute crossover LipiFlow treatment of both eyes.
In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief. In the One LipiFlow Treatment subgroup, no other MGD or dry eye treatment was prescribed for the study duration.
|
Warm Compress/Hygiene Arm: Combination Treatment Subgroup
n=9 Participants
After 3 months of using standardized warm compress therapy and lid hygiene, subjects received a single, 12-minute crossover LipiFlow treatment of both eyes.
In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief. In the Combination Treatment subgroup, subjects received one LipiFlow treatment (at crossover) or two LipiFlow treatments followed by other MGD or dry eye treatment, as prescribed by the physician.
|
|---|---|---|---|---|
|
Stage 2 Mean Total OSDI Score at 12 Months
|
21.6 units on a scale
Interval 18.3 to 24.9
|
35.8 units on a scale
Interval 24.5 to 47.1
|
24.0 units on a scale
Interval 20.5 to 27.6
|
42.2 units on a scale
Interval 25.5 to 58.9
|
Adverse Events
LipiFlow Treatment
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Warm Compress & Lid Hygiene
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Crossover LipiFlow Treatment
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LipiFlow Treatment
n=101 participants at risk
Subjects received a single, 12-minute, in-office treatment of both eyes for MGD with the LipiFlow System after randomization in Stage 1 of study.
|
Warm Compress & Lid Hygiene
n=99 participants at risk
Subjects received twice-daily, standardized warm compress therapy and lid hygiene in both eyes from randomization to 3-month visit in Stage 1.
|
Crossover LipiFlow Treatment
n=94 participants at risk
After using twice-daily, standardized warm compress therapy and lid hygiene for 3 months, subjects received a single, 12-minute crossover LipiFlow treatment of both eyes.
|
|---|---|---|---|
|
Eye disorders
Anterior Staphylococcal Blepharitis
|
0.99%
1/101 • Number of events 2 • Adverse events were collected over 1 year.
Device-related adverse events were evaluated by arm/group. Events occurring during Stage 1 were assessed based on relationship to the LipiFlow Treatment or Warm Compress Therapy and Lid Hygiene. Events occurring in Stage 2 were assessed based on relationship to LipiFlow Treatment or Crossover LipiFlow Treatment.
|
0.00%
0/99 • Adverse events were collected over 1 year.
Device-related adverse events were evaluated by arm/group. Events occurring during Stage 1 were assessed based on relationship to the LipiFlow Treatment or Warm Compress Therapy and Lid Hygiene. Events occurring in Stage 2 were assessed based on relationship to LipiFlow Treatment or Crossover LipiFlow Treatment.
|
0.00%
0/94 • Adverse events were collected over 1 year.
Device-related adverse events were evaluated by arm/group. Events occurring during Stage 1 were assessed based on relationship to the LipiFlow Treatment or Warm Compress Therapy and Lid Hygiene. Events occurring in Stage 2 were assessed based on relationship to LipiFlow Treatment or Crossover LipiFlow Treatment.
|
|
Eye disorders
Blurry Vision
|
0.99%
1/101 • Number of events 1 • Adverse events were collected over 1 year.
Device-related adverse events were evaluated by arm/group. Events occurring during Stage 1 were assessed based on relationship to the LipiFlow Treatment or Warm Compress Therapy and Lid Hygiene. Events occurring in Stage 2 were assessed based on relationship to LipiFlow Treatment or Crossover LipiFlow Treatment.
|
1.0%
1/99 • Number of events 2 • Adverse events were collected over 1 year.
Device-related adverse events were evaluated by arm/group. Events occurring during Stage 1 were assessed based on relationship to the LipiFlow Treatment or Warm Compress Therapy and Lid Hygiene. Events occurring in Stage 2 were assessed based on relationship to LipiFlow Treatment or Crossover LipiFlow Treatment.
|
0.00%
0/94 • Adverse events were collected over 1 year.
Device-related adverse events were evaluated by arm/group. Events occurring during Stage 1 were assessed based on relationship to the LipiFlow Treatment or Warm Compress Therapy and Lid Hygiene. Events occurring in Stage 2 were assessed based on relationship to LipiFlow Treatment or Crossover LipiFlow Treatment.
|
|
Eye disorders
Burning Sensation
|
0.00%
0/101 • Adverse events were collected over 1 year.
Device-related adverse events were evaluated by arm/group. Events occurring during Stage 1 were assessed based on relationship to the LipiFlow Treatment or Warm Compress Therapy and Lid Hygiene. Events occurring in Stage 2 were assessed based on relationship to LipiFlow Treatment or Crossover LipiFlow Treatment.
|
1.0%
1/99 • Number of events 2 • Adverse events were collected over 1 year.
Device-related adverse events were evaluated by arm/group. Events occurring during Stage 1 were assessed based on relationship to the LipiFlow Treatment or Warm Compress Therapy and Lid Hygiene. Events occurring in Stage 2 were assessed based on relationship to LipiFlow Treatment or Crossover LipiFlow Treatment.
|
1.1%
1/94 • Number of events 2 • Adverse events were collected over 1 year.
Device-related adverse events were evaluated by arm/group. Events occurring during Stage 1 were assessed based on relationship to the LipiFlow Treatment or Warm Compress Therapy and Lid Hygiene. Events occurring in Stage 2 were assessed based on relationship to LipiFlow Treatment or Crossover LipiFlow Treatment.
|
|
Eye disorders
Chalazion
|
0.99%
1/101 • Number of events 1 • Adverse events were collected over 1 year.
Device-related adverse events were evaluated by arm/group. Events occurring during Stage 1 were assessed based on relationship to the LipiFlow Treatment or Warm Compress Therapy and Lid Hygiene. Events occurring in Stage 2 were assessed based on relationship to LipiFlow Treatment or Crossover LipiFlow Treatment.
|
0.00%
0/99 • Adverse events were collected over 1 year.
Device-related adverse events were evaluated by arm/group. Events occurring during Stage 1 were assessed based on relationship to the LipiFlow Treatment or Warm Compress Therapy and Lid Hygiene. Events occurring in Stage 2 were assessed based on relationship to LipiFlow Treatment or Crossover LipiFlow Treatment.
|
0.00%
0/94 • Adverse events were collected over 1 year.
Device-related adverse events were evaluated by arm/group. Events occurring during Stage 1 were assessed based on relationship to the LipiFlow Treatment or Warm Compress Therapy and Lid Hygiene. Events occurring in Stage 2 were assessed based on relationship to LipiFlow Treatment or Crossover LipiFlow Treatment.
|
|
Eye disorders
Eye/Eyelid Discomfort/Pain
|
3.0%
3/101 • Number of events 4 • Adverse events were collected over 1 year.
Device-related adverse events were evaluated by arm/group. Events occurring during Stage 1 were assessed based on relationship to the LipiFlow Treatment or Warm Compress Therapy and Lid Hygiene. Events occurring in Stage 2 were assessed based on relationship to LipiFlow Treatment or Crossover LipiFlow Treatment.
|
1.0%
1/99 • Number of events 2 • Adverse events were collected over 1 year.
Device-related adverse events were evaluated by arm/group. Events occurring during Stage 1 were assessed based on relationship to the LipiFlow Treatment or Warm Compress Therapy and Lid Hygiene. Events occurring in Stage 2 were assessed based on relationship to LipiFlow Treatment or Crossover LipiFlow Treatment.
|
1.1%
1/94 • Number of events 2 • Adverse events were collected over 1 year.
Device-related adverse events were evaluated by arm/group. Events occurring during Stage 1 were assessed based on relationship to the LipiFlow Treatment or Warm Compress Therapy and Lid Hygiene. Events occurring in Stage 2 were assessed based on relationship to LipiFlow Treatment or Crossover LipiFlow Treatment.
|
|
Eye disorders
Eyelid Edema/Swelling
|
0.99%
1/101 • Number of events 2 • Adverse events were collected over 1 year.
Device-related adverse events were evaluated by arm/group. Events occurring during Stage 1 were assessed based on relationship to the LipiFlow Treatment or Warm Compress Therapy and Lid Hygiene. Events occurring in Stage 2 were assessed based on relationship to LipiFlow Treatment or Crossover LipiFlow Treatment.
|
1.0%
1/99 • Number of events 2 • Adverse events were collected over 1 year.
Device-related adverse events were evaluated by arm/group. Events occurring during Stage 1 were assessed based on relationship to the LipiFlow Treatment or Warm Compress Therapy and Lid Hygiene. Events occurring in Stage 2 were assessed based on relationship to LipiFlow Treatment or Crossover LipiFlow Treatment.
|
1.1%
1/94 • Number of events 2 • Adverse events were collected over 1 year.
Device-related adverse events were evaluated by arm/group. Events occurring during Stage 1 were assessed based on relationship to the LipiFlow Treatment or Warm Compress Therapy and Lid Hygiene. Events occurring in Stage 2 were assessed based on relationship to LipiFlow Treatment or Crossover LipiFlow Treatment.
|
|
Eye disorders
Eyelid Erythema/Redness
|
0.00%
0/101 • Adverse events were collected over 1 year.
Device-related adverse events were evaluated by arm/group. Events occurring during Stage 1 were assessed based on relationship to the LipiFlow Treatment or Warm Compress Therapy and Lid Hygiene. Events occurring in Stage 2 were assessed based on relationship to LipiFlow Treatment or Crossover LipiFlow Treatment.
|
1.0%
1/99 • Number of events 2 • Adverse events were collected over 1 year.
Device-related adverse events were evaluated by arm/group. Events occurring during Stage 1 were assessed based on relationship to the LipiFlow Treatment or Warm Compress Therapy and Lid Hygiene. Events occurring in Stage 2 were assessed based on relationship to LipiFlow Treatment or Crossover LipiFlow Treatment.
|
0.00%
0/94 • Adverse events were collected over 1 year.
Device-related adverse events were evaluated by arm/group. Events occurring during Stage 1 were assessed based on relationship to the LipiFlow Treatment or Warm Compress Therapy and Lid Hygiene. Events occurring in Stage 2 were assessed based on relationship to LipiFlow Treatment or Crossover LipiFlow Treatment.
|
|
Eye disorders
Eyelid Irritation
|
0.00%
0/101 • Adverse events were collected over 1 year.
Device-related adverse events were evaluated by arm/group. Events occurring during Stage 1 were assessed based on relationship to the LipiFlow Treatment or Warm Compress Therapy and Lid Hygiene. Events occurring in Stage 2 were assessed based on relationship to LipiFlow Treatment or Crossover LipiFlow Treatment.
|
1.0%
1/99 • Number of events 2 • Adverse events were collected over 1 year.
Device-related adverse events were evaluated by arm/group. Events occurring during Stage 1 were assessed based on relationship to the LipiFlow Treatment or Warm Compress Therapy and Lid Hygiene. Events occurring in Stage 2 were assessed based on relationship to LipiFlow Treatment or Crossover LipiFlow Treatment.
|
0.00%
0/94 • Adverse events were collected over 1 year.
Device-related adverse events were evaluated by arm/group. Events occurring during Stage 1 were assessed based on relationship to the LipiFlow Treatment or Warm Compress Therapy and Lid Hygiene. Events occurring in Stage 2 were assessed based on relationship to LipiFlow Treatment or Crossover LipiFlow Treatment.
|
|
Eye disorders
Eyelid Itching
|
0.99%
1/101 • Number of events 1 • Adverse events were collected over 1 year.
Device-related adverse events were evaluated by arm/group. Events occurring during Stage 1 were assessed based on relationship to the LipiFlow Treatment or Warm Compress Therapy and Lid Hygiene. Events occurring in Stage 2 were assessed based on relationship to LipiFlow Treatment or Crossover LipiFlow Treatment.
|
1.0%
1/99 • Number of events 1 • Adverse events were collected over 1 year.
Device-related adverse events were evaluated by arm/group. Events occurring during Stage 1 were assessed based on relationship to the LipiFlow Treatment or Warm Compress Therapy and Lid Hygiene. Events occurring in Stage 2 were assessed based on relationship to LipiFlow Treatment or Crossover LipiFlow Treatment.
|
0.00%
0/94 • Adverse events were collected over 1 year.
Device-related adverse events were evaluated by arm/group. Events occurring during Stage 1 were assessed based on relationship to the LipiFlow Treatment or Warm Compress Therapy and Lid Hygiene. Events occurring in Stage 2 were assessed based on relationship to LipiFlow Treatment or Crossover LipiFlow Treatment.
|
|
Eye disorders
Eyelid Dermatitis
|
0.00%
0/101 • Adverse events were collected over 1 year.
Device-related adverse events were evaluated by arm/group. Events occurring during Stage 1 were assessed based on relationship to the LipiFlow Treatment or Warm Compress Therapy and Lid Hygiene. Events occurring in Stage 2 were assessed based on relationship to LipiFlow Treatment or Crossover LipiFlow Treatment.
|
2.0%
2/99 • Number of events 3 • Adverse events were collected over 1 year.
Device-related adverse events were evaluated by arm/group. Events occurring during Stage 1 were assessed based on relationship to the LipiFlow Treatment or Warm Compress Therapy and Lid Hygiene. Events occurring in Stage 2 were assessed based on relationship to LipiFlow Treatment or Crossover LipiFlow Treatment.
|
0.00%
0/94 • Adverse events were collected over 1 year.
Device-related adverse events were evaluated by arm/group. Events occurring during Stage 1 were assessed based on relationship to the LipiFlow Treatment or Warm Compress Therapy and Lid Hygiene. Events occurring in Stage 2 were assessed based on relationship to LipiFlow Treatment or Crossover LipiFlow Treatment.
|
|
Eye disorders
Flashes/Ocular Migraine
|
0.99%
1/101 • Number of events 1 • Adverse events were collected over 1 year.
Device-related adverse events were evaluated by arm/group. Events occurring during Stage 1 were assessed based on relationship to the LipiFlow Treatment or Warm Compress Therapy and Lid Hygiene. Events occurring in Stage 2 were assessed based on relationship to LipiFlow Treatment or Crossover LipiFlow Treatment.
|
0.00%
0/99 • Adverse events were collected over 1 year.
Device-related adverse events were evaluated by arm/group. Events occurring during Stage 1 were assessed based on relationship to the LipiFlow Treatment or Warm Compress Therapy and Lid Hygiene. Events occurring in Stage 2 were assessed based on relationship to LipiFlow Treatment or Crossover LipiFlow Treatment.
|
0.00%
0/94 • Adverse events were collected over 1 year.
Device-related adverse events were evaluated by arm/group. Events occurring during Stage 1 were assessed based on relationship to the LipiFlow Treatment or Warm Compress Therapy and Lid Hygiene. Events occurring in Stage 2 were assessed based on relationship to LipiFlow Treatment or Crossover LipiFlow Treatment.
|
|
Eye disorders
Gritty Sensation
|
0.00%
0/101 • Adverse events were collected over 1 year.
Device-related adverse events were evaluated by arm/group. Events occurring during Stage 1 were assessed based on relationship to the LipiFlow Treatment or Warm Compress Therapy and Lid Hygiene. Events occurring in Stage 2 were assessed based on relationship to LipiFlow Treatment or Crossover LipiFlow Treatment.
|
1.0%
1/99 • Number of events 2 • Adverse events were collected over 1 year.
Device-related adverse events were evaluated by arm/group. Events occurring during Stage 1 were assessed based on relationship to the LipiFlow Treatment or Warm Compress Therapy and Lid Hygiene. Events occurring in Stage 2 were assessed based on relationship to LipiFlow Treatment or Crossover LipiFlow Treatment.
|
0.00%
0/94 • Adverse events were collected over 1 year.
Device-related adverse events were evaluated by arm/group. Events occurring during Stage 1 were assessed based on relationship to the LipiFlow Treatment or Warm Compress Therapy and Lid Hygiene. Events occurring in Stage 2 were assessed based on relationship to LipiFlow Treatment or Crossover LipiFlow Treatment.
|
|
Eye disorders
Hordeolum
|
0.99%
1/101 • Number of events 1 • Adverse events were collected over 1 year.
Device-related adverse events were evaluated by arm/group. Events occurring during Stage 1 were assessed based on relationship to the LipiFlow Treatment or Warm Compress Therapy and Lid Hygiene. Events occurring in Stage 2 were assessed based on relationship to LipiFlow Treatment or Crossover LipiFlow Treatment.
|
0.00%
0/99 • Adverse events were collected over 1 year.
Device-related adverse events were evaluated by arm/group. Events occurring during Stage 1 were assessed based on relationship to the LipiFlow Treatment or Warm Compress Therapy and Lid Hygiene. Events occurring in Stage 2 were assessed based on relationship to LipiFlow Treatment or Crossover LipiFlow Treatment.
|
0.00%
0/94 • Adverse events were collected over 1 year.
Device-related adverse events were evaluated by arm/group. Events occurring during Stage 1 were assessed based on relationship to the LipiFlow Treatment or Warm Compress Therapy and Lid Hygiene. Events occurring in Stage 2 were assessed based on relationship to LipiFlow Treatment or Crossover LipiFlow Treatment.
|
|
Eye disorders
Increase/Worsening of MGD
|
0.00%
0/101 • Adverse events were collected over 1 year.
Device-related adverse events were evaluated by arm/group. Events occurring during Stage 1 were assessed based on relationship to the LipiFlow Treatment or Warm Compress Therapy and Lid Hygiene. Events occurring in Stage 2 were assessed based on relationship to LipiFlow Treatment or Crossover LipiFlow Treatment.
|
1.0%
1/99 • Number of events 2 • Adverse events were collected over 1 year.
Device-related adverse events were evaluated by arm/group. Events occurring during Stage 1 were assessed based on relationship to the LipiFlow Treatment or Warm Compress Therapy and Lid Hygiene. Events occurring in Stage 2 were assessed based on relationship to LipiFlow Treatment or Crossover LipiFlow Treatment.
|
0.00%
0/94 • Adverse events were collected over 1 year.
Device-related adverse events were evaluated by arm/group. Events occurring during Stage 1 were assessed based on relationship to the LipiFlow Treatment or Warm Compress Therapy and Lid Hygiene. Events occurring in Stage 2 were assessed based on relationship to LipiFlow Treatment or Crossover LipiFlow Treatment.
|
|
Eye disorders
Increase/Worsening of Ocular Dryness
|
0.00%
0/101 • Adverse events were collected over 1 year.
Device-related adverse events were evaluated by arm/group. Events occurring during Stage 1 were assessed based on relationship to the LipiFlow Treatment or Warm Compress Therapy and Lid Hygiene. Events occurring in Stage 2 were assessed based on relationship to LipiFlow Treatment or Crossover LipiFlow Treatment.
|
1.0%
1/99 • Number of events 2 • Adverse events were collected over 1 year.
Device-related adverse events were evaluated by arm/group. Events occurring during Stage 1 were assessed based on relationship to the LipiFlow Treatment or Warm Compress Therapy and Lid Hygiene. Events occurring in Stage 2 were assessed based on relationship to LipiFlow Treatment or Crossover LipiFlow Treatment.
|
2.1%
2/94 • Number of events 4 • Adverse events were collected over 1 year.
Device-related adverse events were evaluated by arm/group. Events occurring during Stage 1 were assessed based on relationship to the LipiFlow Treatment or Warm Compress Therapy and Lid Hygiene. Events occurring in Stage 2 were assessed based on relationship to LipiFlow Treatment or Crossover LipiFlow Treatment.
|
|
Eye disorders
Photophobia/Light Sensitivity
|
0.00%
0/101 • Adverse events were collected over 1 year.
Device-related adverse events were evaluated by arm/group. Events occurring during Stage 1 were assessed based on relationship to the LipiFlow Treatment or Warm Compress Therapy and Lid Hygiene. Events occurring in Stage 2 were assessed based on relationship to LipiFlow Treatment or Crossover LipiFlow Treatment.
|
1.0%
1/99 • Number of events 2 • Adverse events were collected over 1 year.
Device-related adverse events were evaluated by arm/group. Events occurring during Stage 1 were assessed based on relationship to the LipiFlow Treatment or Warm Compress Therapy and Lid Hygiene. Events occurring in Stage 2 were assessed based on relationship to LipiFlow Treatment or Crossover LipiFlow Treatment.
|
1.1%
1/94 • Number of events 1 • Adverse events were collected over 1 year.
Device-related adverse events were evaluated by arm/group. Events occurring during Stage 1 were assessed based on relationship to the LipiFlow Treatment or Warm Compress Therapy and Lid Hygiene. Events occurring in Stage 2 were assessed based on relationship to LipiFlow Treatment or Crossover LipiFlow Treatment.
|
|
Eye disorders
Tearing
|
0.00%
0/101 • Adverse events were collected over 1 year.
Device-related adverse events were evaluated by arm/group. Events occurring during Stage 1 were assessed based on relationship to the LipiFlow Treatment or Warm Compress Therapy and Lid Hygiene. Events occurring in Stage 2 were assessed based on relationship to LipiFlow Treatment or Crossover LipiFlow Treatment.
|
1.0%
1/99 • Number of events 2 • Adverse events were collected over 1 year.
Device-related adverse events were evaluated by arm/group. Events occurring during Stage 1 were assessed based on relationship to the LipiFlow Treatment or Warm Compress Therapy and Lid Hygiene. Events occurring in Stage 2 were assessed based on relationship to LipiFlow Treatment or Crossover LipiFlow Treatment.
|
1.1%
1/94 • Number of events 2 • Adverse events were collected over 1 year.
Device-related adverse events were evaluated by arm/group. Events occurring during Stage 1 were assessed based on relationship to the LipiFlow Treatment or Warm Compress Therapy and Lid Hygiene. Events occurring in Stage 2 were assessed based on relationship to LipiFlow Treatment or Crossover LipiFlow Treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor can review communications for at least 30 days prior to public release with an extension for up to 45 additional days, if the Sponsor notifies the Investigator that the publication contains patentable material or Proprietary Information other than the study results. Upon Sponsor's written request, Investigator agrees to delete any Proprietary Information.
- Publication restrictions are in place
Restriction type: OTHER