Trial Outcomes & Findings for iLux Treatment for Meibomian Gland Dysfunction (MGD) (NCT NCT03055650)

Results Overview

Meibomian glands on the lower eyelid were assessed by the examiner using a Meibomian Gland Evaluator (MGE 1000) device while viewing the eyelid margin with a slit lamp microscope. 5 glands in 3 zones (nasal, medial, temporal) were evaluated. Each gland was scored from 0-3, for a resultant overall score of 0-45 for 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. Eyes were assessed individually.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

Baseline (Day 0 pretreatment), Week 1, Month 1

Results posted on

2020-11-12

Participant Flow

Participants were recruited from 3 investigative sites located in the United States.

This reporting group includes all enrolled participants.

Participant milestones

Participant milestones
Measure	iLux 2020 System Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

iLux Treatment for Meibomian Gland Dysfunction (MGD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	iLux 2020 System n=30 Participants Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual
Age, Continuous	52.9 years STANDARD_DEVIATION 11.9 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Race/Ethnicity, Customized White	20 participants n=5 Participants
Race/Ethnicity, Customized Native American	4 participants n=5 Participants
Race/Ethnicity, Customized Asian	2 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	2 participants n=5 Participants
Race/Ethnicity, Customized Other	1 participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Day 0 pretreatment), Week 1, Month 1

Population: All treated with available data

Meibomian glands on the lower eyelid were assessed by the examiner using a Meibomian Gland Evaluator (MGE 1000) device while viewing the eyelid margin with a slit lamp microscope. 5 glands in 3 zones (nasal, medial, temporal) were evaluated. Each gland was scored from 0-3, for a resultant overall score of 0-45 for 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. Eyes were assessed individually.

Outcome measures

Outcome measures
Measure	iLux 2020 System n=60 eyes Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual
Change From Baseline in Meibomian Gland Secretion (MGS) Total Score Change from Baseline at Week 1	12.3 score on a scale Standard Deviation 7.1
Change From Baseline in Meibomian Gland Secretion (MGS) Total Score Change from Baseline at Month 1	14.5 score on a scale Standard Deviation 7.9

PRIMARY outcome

Timeframe: Baseline (Day 0 pretreatment), Week 1, Month 1

Population: All treated with available data

The investigator instilled a drop of fluorescein into the lower eyelid and asked the patient to blink several times, then stop. The time between the last blink and the first appearance of a dark spot on the cornea (formation of a dry area) on the otherwise continuously stained tear film was recorded in seconds. 3 consecutive measurements were taken, with TBUT defined as the average of the 3 measurements. A positive change value represents A positive change value represents a more stable tear film (improvement). Eyes were assessed individually.

Outcome measures

Outcome measures
Measure	iLux 2020 System n=60 eyes Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual
Change From Baseline in Tear Break-Up Time (TBUT) Change from Baseline at Week 1	3.6 seconds Standard Deviation 3.1
Change From Baseline in Tear Break-Up Time (TBUT) Change from Baseline at Month 1	4.6 seconds Standard Deviation 3.1

SECONDARY outcome

Timeframe: Baseline (Day 0 pretreatment), Week 1, Month 1

Population: All treated with available data

The Standard Patient Evaluation of Eye Dryness (SPEED) survey is a validated survey that assesses both the frequency and severity of dry eye symptoms. The patient grades the frequency of symptoms (4 items) on a scale from 0 to 3 (0=never; 3=constant) and the severity of each symptom (4 items) on a scale from 0 to 4 (0=no problems; 4=intolerable). Responses to the 8 items are summed to calculate a total score ranging from 0 to 28, where 0=best and 28=worst. A negative change value indicates a perceived improvement in ocular health. Both eyes contributed to the mean.

Outcome measures

Outcome measures
Measure	iLux 2020 System n=30 Participants Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual
Change From Baseline in Standard Patient Evaluation of Eye Dryness (SPEED) Total Score Change from Baseline at Week 1	-8.6 score on a scale Standard Deviation 7.0
Change From Baseline in Standard Patient Evaluation of Eye Dryness (SPEED) Total Score Change from Baseline at Month 1	-9.1 score on a scale Standard Deviation 6.6

SECONDARY outcome

Timeframe: Baseline (Day 0 pretreatment), Month 1

Population: All treated with available data

The OSDI is a validated, 12-item questionnaire used to measure ocular symptoms, visual function, and environmental factors that may affect a patient's vision. The patient grades each item on a scale from 0 to 4, where 0 is "None" and 4 is "All of the Time." Responses to the 12 items are summed, and a formula is used to calculate a total score from 0 to 100, where 0 corresponds to no disability and 100 corresponds to complete disability. A negative change value represents a perceived improvement in ocular health. Both eyes contributed to the mean.

Outcome measures

Outcome measures
Measure	iLux 2020 System n=30 Participants Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual
Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score	-28.5 score on a scale Standard Deviation 22.0

Adverse Events

iLux 2020 System

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

Senior CDMA Project Lead, CDMA Ocular Health

Alcon Research, LLC

Phone: 1-888-451-3937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place