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 range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mean Change in the Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire Score From Baseline to 1 Month

Timeframe: 1 month

Trial details

NCT IDNCT04159935

SponsorUniversity of Waterloo

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-04-14

Results submitted2022-11-07

View on ClinicalTrials.gov More Dry Eye trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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;

Investigating iLux Efficacy in Contact Lens Wearers With Evaporative Dry Eye Disease

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Investigating iLux Efficacy in Contact Lens Wearers With Evaporative Dry Eye Disease

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria