Investigating iLux Efficacy in Contact Lens Wearers With Evaporative Dry Eye Disease (NCT04159935) | Clinical Trial Compass
TerminatedPhase 4
Investigating iLux Efficacy in Contact Lens Wearers With Evaporative Dry Eye Disease
Stopped: Cancelled due to COVID-19
Canada28 participantsStarted 2019-11-15
Plain-language summary
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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Is at least 18 years of age and has full legal capacity to volunteer;
✓. Has read and signed an information consent letter;
✓. Is willing and able to follow instructions and maintain the appointment schedule;
✓. Has been using the same CL type (brand, material and dimensions) for \> 3 months;
✓. Wears commercially available soft CLs on average \>2 hours per day, 4-7 days per week;
✓. Is willing to try to wear their habitual CLs on average ≥ 6 hours per day, 4-7 days per week and maintain this for the duration of their involvement in the study;
✓. Demonstrates an acceptable lens fit of their habitual contact lenses;
✓. Does not have contact lens discomfort due to contact lens fit, lens material or known solution compatibility issues, in the opinion of the investigator;
Exclusion criteria
✕. Is participating in any concurrent clinical or research study;
✕. Has used any prescription systemic medications or topical treatments for MGD or dry eye for the past 30 days prior to the screening visit and not willing to stop using these for the study duration (excluding over-the-counter artificial tears, dietary supplements and ocular lubricants but includes warm compresses, eyelid massage, eyelid hygiene, manual meibomian gland expression, punctal plug insertion or punctal occlusion, intense pulsed light treatment of the face or eyelids);
What they're measuring
1
Mean Change in the Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire Score From Baseline to 1 Month
. Has previously received treatment with an eyelid thermal pulsation device;
✕. Has a history of any of the following ocular (eye or eyelid) conditions or procedures in either eye within the past 90 days prior to the screening visit:
✕. Ocular trauma
✕. Chemical burns
✕. Ocular Herpes simplex or Herpes zoster infection