The purpose of this clinical trial is to investigate the efficacy of a single iLux® treatment in symptomatic CL wearers who have DED (according to the TFOS DEWS II diagnostic criteria), of the evaporative dry eye disease subtype (EDE).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Commercially available medical device intended for use by qualified eye care professionals to apply localized heat and pressure therapy to a patient's eyelids.
Centre for Ocular Research & Education
Waterloo, Ontario, Canada
Mean Change in the Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire Score From Baseline to 1 Month
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.
Time frame: 1 month
Meibomian Gland Score at 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.
Time frame: Baseline
Meibomian Gland Score 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.
Time frame: 1 Month
Meibomian Gland Score at 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.
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Time frame: 3 Months
Comfortable Contact Lens Wear Time at Baseline
Participants reported how long the contact lenses on average were comfortable (comfortable wear time).
Time frame: Baseline
Comfortable Contact Lens Wear Time at 1 Month
Participants reported how long the contact lenses on average were comfortable (comfortable wear time).
Time frame: 1 Month
Comfortable Contact Lens Wear Time at 3 Months
Participants reported how long the contact lenses on average were comfortable (comfortable wear time).
Time frame: 3 Months
Pre-lens Tear Break-up Time at 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.
Time frame: Baseline
Pre-lens Tear Break-up Time at 1 Month
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.
Time frame: 1 Month
Pre-lens Tear Break-up Time at 3 Months
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.
Time frame: 3 Months
Average Contact Lens Wear Time at Baseline
Participants reported how long they wore their contact lenses on average per day (total wear time).
Time frame: Baseline
Average Contact Lens Wear Time at 1 Month
Participants reported how long they wore their contact lenses on average per day (total wear time).
Time frame: 1 Month
Average Contact Lens Wear Time at 3 Months
Participants reported how long they wore their contact lenses on average per day (total wear time).
Time frame: 3 Months