Trial Outcomes & Findings for Investigating iLux Efficacy in Contact Lens Wearers With Evaporative Dry Eye Disease (NCT NCT04159935)

NCT ID: NCT04159935

Last Updated: 2023-05-16

Results Overview

The mean change in dry eye symptoms from baseline based on the Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire score was evaluated 1 month after iLux treatment. The SPEED questionnaire is a dry eye questionnaire developed to assess the frequency (0-3 scale, with higher values indicating more frequent symptoms) and severity (0-4 scale, with higher values indicating more severe symptoms) of patient symptoms. Scores range from 0-28. A higher SPEED score represents more frequent and/or more severe symptoms.

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 28 participants
• Primary outcome timeframe: 1 month
• Results posted on: 2023-05-16

Participant Flow

Participants were recruited at a single site between November 2019 and March 2020. The first participant was enrolled on November 15, 2019 and the last participant was enrolled on March 4, 2020.

Of 28 enrolled participants, 8 met inclusion criteria and were randomized to treatment.

Participant milestones

Measure	iLux® Treatment The treatment group will receive iLux® treatment at Visit 1 and will be reviewed 1- and 3-months after iLux® treatment.	Delayed iLux® Treatment Delayed iLux® treatment provided after 1 month (i.e. 1 month of no treatment, administer treatment after 1 month). Review 1- and 3-months after iLux® treatment.
Overall Study STARTED	4	4
Overall Study Month 1 Post-treatment	3	3
Overall Study Month 3 Post-treatment	3	1
Overall Study COMPLETED	3	1
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Measure	iLux® Treatment The treatment group will receive iLux® treatment at Visit 1 and will be reviewed 1- and 3-months after iLux® treatment.	Delayed iLux® Treatment Delayed iLux® treatment provided after 1 month (i.e. 1 month of no treatment, administer treatment after 1 month). Review 1- and 3-months after iLux® treatment.
Overall Study Study terminated due to COVID-19	1	3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	iLux® Treatment n=4 Participants The treatment group will receive iLux® treatment at Visit 1 and will be reviewed 1- and 3-months after iLux® treatment.	Delayed iLux® Treatment n=4 Participants Delayed iLux® treatment provided after 1 month (i.e. 1 month of no treatment, administer treatment after 1 month). Review 1- and 3-months after iLux® treatment.	Total n=8 Participants Total of all reporting groups
Age, Continuous	37.0 Years STANDARD_DEVIATION 19.6 • n=4 Participants	30.3 Years STANDARD_DEVIATION 13.2 • n=4 Participants	33.6 Years STANDARD_DEVIATION 15.9 • n=8 Participants
Sex: Female, Male Female	4 Participants n=4 Participants	3 Participants n=4 Participants	7 Participants n=8 Participants
Sex: Female, Male Male	0 Participants n=4 Participants	1 Participants n=4 Participants	1 Participants n=8 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Canada	4 participants n=4 Participants	4 participants n=4 Participants	8 participants n=8 Participants
Standard Patient Evaluation of Eye Dryness Questionnaire score	14 scores on a scale STANDARD_DEVIATION 6.6 • n=4 Participants	11.8 scores on a scale STANDARD_DEVIATION 3.8 • n=4 Participants	12.9 scores on a scale STANDARD_DEVIATION 5.1 • n=8 Participants

PRIMARY outcome

Timeframe: 1 month

Population: 1 participant in each arm lost to follow-up due to COVID-19.

The mean change in dry eye symptoms from baseline based on the Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire score was evaluated 1 month after iLux treatment. The SPEED questionnaire is a dry eye questionnaire developed to assess the frequency (0-3 scale, with higher values indicating more frequent symptoms) and severity (0-4 scale, with higher values indicating more severe symptoms) of patient symptoms. Scores range from 0-28. A higher SPEED score represents more frequent and/or more severe symptoms.

Outcome measures

Measure	iLux® Treatment n=3 Participants The treatment group will receive iLux® treatment at Visit 1 and will be reviewed 1- and 3-months after iLux® treatment.	Delayed iLux® Treatment n=3 Participants Delayed iLux® treatment provided after 1 month (i.e. 1 month of no treatment, administer treatment after 1 month). Review 1- and 3-months after iLux® treatment.
Mean Change in the Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire Score From Baseline to 1 Month	2.0 scores on a scale Standard Deviation 1.7	-2.0 scores on a scale Standard Deviation 6.2

SECONDARY outcome

Timeframe: Baseline

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

Measure	iLux® Treatment n=4 Participants The treatment group will receive iLux® treatment at Visit 1 and will be reviewed 1- and 3-months after iLux® treatment.	Delayed iLux® Treatment n=4 Participants Delayed iLux® treatment provided after 1 month (i.e. 1 month of no treatment, administer treatment after 1 month). Review 1- and 3-months after iLux® treatment.
Meibomian Gland Score at Baseline	10.5 scores on a scale Standard Deviation 4.7	10.5 scores on a scale Standard Deviation 4.1

SECONDARY outcome

Timeframe: 1 Month

Population: 1 participant in each arm was lost to follow-up due to COVID-19.

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

Measure	iLux® Treatment n=3 Participants The treatment group will receive iLux® treatment at Visit 1 and will be reviewed 1- and 3-months after iLux® treatment.	Delayed iLux® Treatment n=3 Participants Delayed iLux® treatment provided after 1 month (i.e. 1 month of no treatment, administer treatment after 1 month). Review 1- and 3-months after iLux® treatment.
Meibomian Gland Score at 1 Month	21.3 scores on a scale Standard Deviation 11.7	20.3 scores on a scale Standard Deviation 10.1

SECONDARY outcome

Timeframe: 3 Months

Population: 2 participants in the iLux® treatment group were assessed remotely due to the COVID-19 shutdown. Meibomian gland score was unable to be assessed via a remote visit. 1 participant in the iLux® treatment group and 3 participants in the delayed iLux® treatment group were lost to follow-up due to COVID-19. Meibomian gland score was not assessed in the 1 person in the delayed iLux® treatment group that completed the study as per the protocol.

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

Measure	iLux® Treatment n=1 Participants The treatment group will receive iLux® treatment at Visit 1 and will be reviewed 1- and 3-months after iLux® treatment.	Delayed iLux® Treatment Delayed iLux® treatment provided after 1 month (i.e. 1 month of no treatment, administer treatment after 1 month). Review 1- and 3-months after iLux® treatment.
Meibomian Gland Score at 3 Months	15 score on a scale Interval 15.0 to 15.0	—

SECONDARY outcome

Timeframe: Baseline

Participants reported how long the contact lenses on average were comfortable (comfortable wear time).

Outcome measures

Measure	iLux® Treatment n=4 Participants The treatment group will receive iLux® treatment at Visit 1 and will be reviewed 1- and 3-months after iLux® treatment.	Delayed iLux® Treatment n=4 Participants Delayed iLux® treatment provided after 1 month (i.e. 1 month of no treatment, administer treatment after 1 month). Review 1- and 3-months after iLux® treatment.
Comfortable Contact Lens Wear Time at Baseline	4.3 Hours per day Standard Deviation 2.6	2.3 Hours per day Standard Deviation 1.0

SECONDARY outcome

Timeframe: 1 Month

Population: 1 participant in each arm lost to follow-up due to COVID-19.

Participants reported how long the contact lenses on average were comfortable (comfortable wear time).

Outcome measures

Measure	iLux® Treatment n=3 Participants The treatment group will receive iLux® treatment at Visit 1 and will be reviewed 1- and 3-months after iLux® treatment.	Delayed iLux® Treatment n=3 Participants Delayed iLux® treatment provided after 1 month (i.e. 1 month of no treatment, administer treatment after 1 month). Review 1- and 3-months after iLux® treatment.
Comfortable Contact Lens Wear Time at 1 Month	7.0 Hours per day Standard Deviation 4.6	4.0 Hours per day Standard Deviation 2.0

SECONDARY outcome

Timeframe: 3 Months

Population: Participants lost to follow-up due to COVID-19.

Participants reported how long the contact lenses on average were comfortable (comfortable wear time).

Outcome measures

Measure	iLux® Treatment n=3 Participants The treatment group will receive iLux® treatment at Visit 1 and will be reviewed 1- and 3-months after iLux® treatment.	Delayed iLux® Treatment n=1 Participants Delayed iLux® treatment provided after 1 month (i.e. 1 month of no treatment, administer treatment after 1 month). Review 1- and 3-months after iLux® treatment.
Comfortable Contact Lens Wear Time at 3 Months	9.0 Hours per day Standard Deviation 3.6	2 Hours per day

SECONDARY outcome

Timeframe: Baseline

The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The time required for a dry spot to appear on the contact lens surface after blinking is referred to as the pre-lens tear break-up time. Three measurements are taken and averaged together. A higher number represents a longer pre-lens tear break-up time.

Outcome measures

Measure	iLux® Treatment n=4 Participants The treatment group will receive iLux® treatment at Visit 1 and will be reviewed 1- and 3-months after iLux® treatment.	Delayed iLux® Treatment n=4 Participants Delayed iLux® treatment provided after 1 month (i.e. 1 month of no treatment, administer treatment after 1 month). Review 1- and 3-months after iLux® treatment.
Pre-lens Tear Break-up Time at Baseline	5.1 Seconds Standard Deviation 2.9	4.0 Seconds Standard Deviation 1.1

SECONDARY outcome

Timeframe: 1 Month

Population: 1 participant in each arm lost to follow-up due to COVID-19.

The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The time required for a dry spot to appear on the contact lens surface after blinking is referred to as the pre-lens tear break-up time. Three measurements are taken and averaged together. A higher number represents a longer pre-lens tear break-up time.

Outcome measures

Measure	iLux® Treatment n=3 Participants The treatment group will receive iLux® treatment at Visit 1 and will be reviewed 1- and 3-months after iLux® treatment.	Delayed iLux® Treatment n=3 Participants Delayed iLux® treatment provided after 1 month (i.e. 1 month of no treatment, administer treatment after 1 month). Review 1- and 3-months after iLux® treatment.
Pre-lens Tear Break-up Time at 1 Month	5.8 Seconds Standard Deviation 3.9	3.3 Seconds Standard Deviation 1.3

SECONDARY outcome

Timeframe: 3 Months

Population: 2 participants in the iLux® treatment group had a remote visit due to the COVID-19 closure of the site. Pre-lens tear break-up time was unable to be assessed using a remote visit. 1 participant in the iLux® treatment group and 3 participants in the delayed iLux® treatment group were lost to follow-up due to COVID-19. Pre-lens tear break-up time was not assessed in the 1 person in the delayed iLux® treatment group that completed the study as per the protocol.

The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The time required for a dry spot to appear on the contact lens surface after blinking is referred to as the pre-lens tear break-up time. Three measurements are taken and averaged together. A higher number represents a longer pre-lens tear break-up time.

Outcome measures

Measure	iLux® Treatment n=1 Participants The treatment group will receive iLux® treatment at Visit 1 and will be reviewed 1- and 3-months after iLux® treatment.	Delayed iLux® Treatment Delayed iLux® treatment provided after 1 month (i.e. 1 month of no treatment, administer treatment after 1 month). Review 1- and 3-months after iLux® treatment.
Pre-lens Tear Break-up Time at 3 Months	5.6 Seconds Interval 5.6 to 5.6	—

SECONDARY outcome

Timeframe: Baseline

Participants reported how long they wore their contact lenses on average per day (total wear time).

Outcome measures

Measure	iLux® Treatment n=4 Participants The treatment group will receive iLux® treatment at Visit 1 and will be reviewed 1- and 3-months after iLux® treatment.	Delayed iLux® Treatment n=4 Participants Delayed iLux® treatment provided after 1 month (i.e. 1 month of no treatment, administer treatment after 1 month). Review 1- and 3-months after iLux® treatment.
Average Contact Lens Wear Time at Baseline	10.5 Hours per day Standard Deviation 3.7	7.3 Hours per day Standard Deviation 2.5

SECONDARY outcome

Timeframe: 1 Month

Population: 1 participant in each arm lost to follow-up due to COVID-19.

Participants reported how long they wore their contact lenses on average per day (total wear time).

Outcome measures

Measure	iLux® Treatment n=3 Participants The treatment group will receive iLux® treatment at Visit 1 and will be reviewed 1- and 3-months after iLux® treatment.	Delayed iLux® Treatment n=3 Participants Delayed iLux® treatment provided after 1 month (i.e. 1 month of no treatment, administer treatment after 1 month). Review 1- and 3-months after iLux® treatment.
Average Contact Lens Wear Time at 1 Month	12.3 Hours per day Standard Deviation 5.5	8.0 Hours per day Standard Deviation 0.0

SECONDARY outcome

Timeframe: 3 Months

Population: Participants lost to follow-up due to COVID-19.

Participants reported how long they wore their contact lenses on average per day (total wear time).

Outcome measures

Measure	iLux® Treatment n=3 Participants The treatment group will receive iLux® treatment at Visit 1 and will be reviewed 1- and 3-months after iLux® treatment.	Delayed iLux® Treatment n=1 Participants Delayed iLux® treatment provided after 1 month (i.e. 1 month of no treatment, administer treatment after 1 month). Review 1- and 3-months after iLux® treatment.
Average Contact Lens Wear Time at 3 Months	12.7 Hours per day Standard Deviation 4.2	8 Hours per day Standard Deviation 0

Adverse Events

iLux® Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Delayed iLux® 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

Jill Woods

Centre for Ocular Research and Education

Phone: 5198884567

Email: jwoods@uwaterloo.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place