Trial Outcomes & Findings for Treatment of Meibomian Gland Dysfunction and Dry Eye in Contact Lens Wearers (NCT NCT02102464)

Last Updated: 2017-10-18

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

55 participants

Primary outcome timeframe

3 Months

Results posted on

2017-10-18

Participant Flow

Unit of analysis: Eyes

Participant milestones

Participant milestones
Measure	LipiFlow 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 Untreated Control (No Intervention)	Crossover LipiFlow Untreated Control Subjects received a 12-minute LipiFlow treatment after the 3-month visit
Randomized Study STARTED	29 58	26 52	0 0
Randomized Study COMPLETED	29 58	25 50	0 0
Randomized Study NOT COMPLETED	0 0	1 2	0 0
Crossover LipiFlow Treatment of Control STARTED	0 0	0 0	25 50
Crossover LipiFlow Treatment of Control COMPLETED	0 0	0 0	25 50
Crossover LipiFlow Treatment of Control NOT COMPLETED	0 0	0 0	0 0

Reasons for withdrawal

Reasons for withdrawal
Measure	LipiFlow 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 Untreated Control (No Intervention)	Crossover LipiFlow Untreated Control Subjects received a 12-minute LipiFlow treatment after the 3-month visit
Randomized Study Withdrawal by Subject	0	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LipiFlow n=58 Eyes 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 n=52 Eyes Untreated Control (No Intervention)	Total n=110 Eyes Total of all reporting groups
Age, Continuous	40.0 years STANDARD_DEVIATION 13.1 • n=5 Participants	43.5 years STANDARD_DEVIATION 15.9 • n=7 Participants	41.7 years STANDARD_DEVIATION 14.5 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	22 Participants n=7 Participants	47 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants n=5 Participants	25 Participants n=7 Participants	54 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants	16 Participants n=7 Participants	33 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Canada	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Region of Enrollment United States	21 Participants n=5 Participants	18 Participants n=7 Participants	39 Participants n=5 Participants
Meibomian Gland Score	8.0 units on a scale STANDARD_DEVIATION 3.5 • n=14 Eyes	8.2 units on a scale STANDARD_DEVIATION 4.2 • n=23 Eyes	8.1 units on a scale STANDARD_DEVIATION 3.8 • n=50 Eyes
SPEED Score	14.5 units on a scale STANDARD_DEVIATION 4.8 • n=5 Participants	15.3 units on a scale STANDARD_DEVIATION 4.5 • n=7 Participants	14.9 units on a scale STANDARD_DEVIATION 4.6 • n=5 Participants
Comfortable Contact Lens Wear Time	5.4 hours per day STANDARD_DEVIATION 3.4 • n=5 Participants	4.3 hours per day STANDARD_DEVIATION 3.1 • n=7 Participants	4.9 hours per day STANDARD_DEVIATION 3.3 • n=5 Participants

PRIMARY outcome

Timeframe: 3 Months

Population: Intent to Treat (ITT) Population of all randomized subjects.

Outcome measures

Outcome measures
Measure	LipiFlow n=58 Eyes 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 n=50 Eyes Untreated Control (No Intervention)
Mean Change in Meibomian Gland Score From Baseline at 3 Months	12.4 units on a scale Interval 10.0 to 14.8	1.4 units on a scale Interval -0.4 to 3.3

SECONDARY outcome

Timeframe: 3 Months

Population: Intent to Treat (ITT) Population of all randomized subjects.

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.

Outcome measures

Outcome measures
Measure	LipiFlow n=29 Participants 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 n=25 Participants Untreated Control (No Intervention)
Mean Change in Dry Eye Questionnaire Score From Baseline at 3 Months	-8.4 units on a scale Interval -10.2 to -6.6	-0.7 units on a scale Interval -2.5 to 1.1

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 Months

Population: Intent to Treat (ITT) of all randomized subjects

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.

Outcome measures

Outcome measures
Measure	LipiFlow n=29 Participants 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 n=25 Participants Untreated Control (No Intervention)
Mean Change in Comfortable Contact Lens Wear Time From Baseline at 3 Months	3.7 hours per day Interval 2.8 to 4.5	-0.3 hours per day Interval -0.8 to 0.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 Month

Population: Intent to Treat (All randomized subjects)

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.

Outcome measures

Outcome measures
Measure	LipiFlow n=58 Eyes 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 n=50 Eyes Untreated Control (No Intervention)
Mean Change in Meibomian Gland Score From Baseline at 1 Month	11.7 units on a scale Interval 9.2 to 14.2	14.3 units on a scale Interval 11.1 to 17.5

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 Month

Population: Intent to Treat (All randomized subjects)

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.

Outcome measures

Outcome measures
Measure	LipiFlow n=58 Eyes 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 n=50 Eyes Untreated Control (No Intervention)
Mean Change in Dry Eye Questionnaire From Baseline at 1 Month	-8.3 units on a scale Interval -10.1 to -6.5	-8.1 units on a scale Interval -10.7 to -5.5

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 Month

Population: Intent to Treat (all randomized subjects)

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.

Outcome measures

Outcome measures
Measure	LipiFlow n=58 Eyes 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 n=50 Eyes Untreated Control (No Intervention)
Mean Change in Comfortable Contact Lens Wear Time From Baseline at 1 Month	4.0 hours per day Interval 2.9 to 5.1	3.7 hours per day Interval 2.5 to 4.8

Adverse Events

LipiFlow

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Untreated Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Crossover LipiFlow Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

VP Clinical and Regulatory Affairs

TearScience, Inc.

Phone: 919-467-4007

Email: [email protected]

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