18 and older, any sex, with Dry Eye. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Mean Change in the Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire Score From Baseline to 1 MonthPrimary· 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.
Group
Value
95% CI
iLux® Treatment
2.0
± 1.7
Delayed iLux® Treatment
-2.0
± 6.2
Meibomian Gland Score at BaselineSecondary· 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.
Group
Value
95% CI
iLux® Treatment
10.5
± 4.7
Delayed iLux® Treatment
10.5
± 4.1
Meibomian Gland Score at 1 MonthSecondary· 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.
Group
Value
95% CI
iLux® Treatment
21.3
± 11.7
Delayed iLux® Treatment
20.3
± 10.1
Meibomian Gland Score at 3 MonthsSecondary· 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.
Group
Value
95% CI
iLux® Treatment
15
15 – 15
Comfortable Contact Lens Wear Time at BaselineSecondary· Baseline
Participants reported how long the contact lenses on average were comfortable (comfortable wear time).
Group
Value
95% CI
iLux® Treatment
4.3
± 2.6
Delayed iLux® Treatment
2.3
± 1.0
Comfortable Contact Lens Wear Time at 1 MonthSecondary· 1 Month
Participants reported how long the contact lenses on average were comfortable (comfortable wear time).
Group
Value
95% CI
iLux® Treatment
7.0
± 4.6
Delayed iLux® Treatment
4.0
± 2.0
Comfortable Contact Lens Wear Time at 3 MonthsSecondary· 3 Months
Participants reported how long the contact lenses on average were comfortable (comfortable wear time).
Group
Value
95% CI
iLux® Treatment
9.0
± 3.6
Delayed iLux® Treatment
2
Pre-lens Tear Break-up Time at BaselineSecondary· 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.
Group
Value
95% CI
iLux® Treatment
5.1
± 2.9
Delayed iLux® Treatment
4.0
± 1.1
Pre-lens Tear Break-up Time at 1 MonthSecondary· 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.
Group
Value
95% CI
iLux® Treatment
5.8
± 3.9
Delayed iLux® Treatment
3.3
± 1.3
Pre-lens Tear Break-up Time at 3 MonthsSecondary· 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.
Group
Value
95% CI
iLux® Treatment
5.6
5.6 – 5.6
Average Contact Lens Wear Time at BaselineSecondary· Baseline
Participants reported how long they wore their contact lenses on average per day (total wear time).
Group
Value
95% CI
iLux® Treatment
10.5
± 3.7
Delayed iLux® Treatment
7.3
± 2.5
Average Contact Lens Wear Time at 1 MonthSecondary· 1 Month
Participants reported how long they wore their contact lenses on average per day (total wear time).
Group
Value
95% CI
iLux® Treatment
12.3
± 5.5
Delayed iLux® Treatment
8.0
± 0.0
Sponsor's own description
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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
NCT07366944 — PCOS and Problem of Eye Dryness: Is There a Benefit From Lifetyle Changes
· NA
· recruiting
NCT07329712 — Comparing Tear Proteomics Profile in Dry Eye Disease pre-and Post-treatment With Low Level Light Therapy
· recruiting
NCT07266948 — Impact of TRYPTYR on a Patient's Quality of Life and Ability to Perform Work
· Phase 4
· recruiting
NCT07298811 — Preliminary Clinical Study of the Effectiveness and Safety of Ocular Surface Microbiota Transplantation in the Treatment
· Phase 1, PHASE2
· recruiting
NCT07135193 — Evaluation of the Protective Effects of Cordyceps Cicadae on Visual Function and Anti-Fatigue Performance in Esports Ath
· NA
· active not recruiting
Other University of Waterloo trials
Trials by the same sponsor.
NCT07505407 — CHOICE+ Quality Improvement for Long Term Care Homes
· enrolling by invitation
NCT07341763 — Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment
· NA
· not yet recruiting
NCT07451184 — Comparison of Ocular Lubricants in People With Symptoms of Dry Eye
· Phase 4
· recruiting
NCT07288684 — Chiropractor Delivered Virtual Intervention After Vertebral frActure
· NA
· recruiting
NCT06966349 — Quantifying Ocular Surface Aberrations After Tear Film Interventions
· Phase 4
· recruiting
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Waterloo
Last refreshed: 16 May 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04159935.