Trial Outcomes & Findings for Meibomian Gland Dysfunction Treatment (NCT NCT04229888)

NCT ID: NCT04229888

Last Updated: 2022-03-29

Results Overview

DEQ5 total score ranges from 0-22 with the higher scores indicating increased dry eye.

Recruitment status

COMPLETED

Study phase

Target enrollment

14 participants

Primary outcome timeframe

2 weeks

Results posted on

2022-03-29

Participant Flow

14 subjects total were enrolled which is less than what was expected (15) due to time constraints

Participant milestones

Participant milestones
Measure	Subject Treatment All subjects will receive light based (sham) treatment, then all subjects will receive LipiFlow treatment.
Overall Study STARTED	14
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Meibomian Gland Dysfunction Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Subject Treatment n=14 Participants All subjects will receive light based treatment, then all subjects will receive LipiFlow treatment.
Age, Continuous	59.57 years STANDARD_DEVIATION 16.65 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks

DEQ5 total score ranges from 0-22 with the higher scores indicating increased dry eye.

Outcome measures

Outcome measures
Measure	Subjects Treatment Light Based (Sham) n=14 Participants All subjects will receive light based (sham) treatment. Light Based Treatment: A light based (sham) treatment will be used to compare effectiveness to the LipiFlow treatment.	Subjects Treatment LipiFlow n=14 Participants All subjects will receive LipiFlow treatment. LipiFlow: Medical device that applies a combination of heat and pressure to the inner eyelid to remove gland obstructions and stagnant gland content
Dry Eye Questionnaire 5 (DEQ-5) Score	11.8 score on a scale Standard Deviation 3.9	11.8 score on a scale Standard Deviation 4.4

SECONDARY outcome

Timeframe: 2 weeks

Meibomian glands evaluated on the lower eyelid using meibomian gland evaluator. 5 glands in 3 regions (nasal, central, temporal) evaluated and scored from 0 to 4 for a max score of 60 in each eye. (MGS scale 0 = clear, 1 = cloudy, 2 = granular, 3 = pastelike, 4 = obstruction)

Outcome measures

Outcome measures
Measure	Subjects Treatment Light Based (Sham) n=14 Participants All subjects will receive light based (sham) treatment. Light Based Treatment: A light based (sham) treatment will be used to compare effectiveness to the LipiFlow treatment.	Subjects Treatment LipiFlow n=14 Participants All subjects will receive LipiFlow treatment. LipiFlow: Medical device that applies a combination of heat and pressure to the inner eyelid to remove gland obstructions and stagnant gland content
Meibomian Gland Score	53.2 score on a scale Standard Deviation 7.9	52.6 score on a scale Standard Deviation 7.9

SECONDARY outcome

Timeframe: 2 weeks

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 TBUT. A positive change value represents a lengthening in the tear break-up time and greater comfort.

Outcome measures

Outcome measures
Measure	Subjects Treatment Light Based (Sham) n=14 Participants All subjects will receive light based (sham) treatment. Light Based Treatment: A light based (sham) treatment will be used to compare effectiveness to the LipiFlow treatment.	Subjects Treatment LipiFlow n=14 Participants All subjects will receive LipiFlow treatment. LipiFlow: Medical device that applies a combination of heat and pressure to the inner eyelid to remove gland obstructions and stagnant gland content
Tear Break-Up Time (TBUT)	7.11 seconds Standard Deviation 9.09	5.62 seconds Standard Deviation 6.77

Adverse Events

Light Based (Sham) Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

LipiFlow Treatment

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

Anna Tichenor

Indiana University School of Optometry

Phone: 812-855-0520

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place