Performance of DAILIES TOTAL1 Daily Disposable Contact Lenses in Habitual Soft Lens Wearers Who R… (NCT06308666) | Clinical Trial Compass
CompletedNot Applicable
Performance of DAILIES TOTAL1 Daily Disposable Contact Lenses in Habitual Soft Lens Wearers Who Report Substantial Digital Device Use
Canada41 participantsStarted 2024-03-18
Plain-language summary
The purpose of this study is to evaluate the performance of DAILIES TOTAL1 daily disposable contact lenses with regards to subjective symptoms (comfort, dryness, vision) in lens wearers who use identify themselves as substantial digital device users (at least eight hours of digital device use per day).
Who can participate
Age range
18 Years – 40 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
. Are between 18 and 40 years of age (inclusive) and has full legal capacity to volunteer;
. Have read and signed an information consent letter;
. Are willing and able to follow instructions and maintain the appointment schedule;
. Are a digital device user (at least 8 hours on a typical day using any combination of digital devices such as personal computer \[PC\], laptop, smartphone or tablet);
. Are a habitual wearer of daily wear, spherical, soft contact lenses (no bifocal or multifocal contact lenses, no extended wear or monovision) for at least 5 days/week and at least 13+ hours/day on a typical day during the month prior to enrolment;
. The habitual lens type brand will be restricted such that a maximum of 7 participants will be included in the study for each lens brand/material;
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
1
Subjective Rating of Comfort After 8 Hours or More of Digital Device Use
Timeframe: Day 14+2
2
Subjective Rating of Dryness After 8 Hours or More of Digital Device Use
Timeframe: Day 14+2
3
Subjective Rating of Clarity of Vision After 8 Hours or More of Digital Device Use
. Have a vertex corrected spherical equivalent distance refraction within -0.50 Diopter (D) to -9.00D in each eye;
. Have a vertex corrected refractive cylinder ≤ -0.75 cylindrical correction in each eye after vertexing to the corneal plane;
Exclusion criteria
. Are participating in any concurrent clinical or research study involving intervention or invasive ocular tests;
. Are presbyopic or habitually use a reading addition for close work;
. Have any known active\* ocular disease and/or infection; \[\* For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and mild dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.\]
. Meet the diagnosis of dry eye disease as per the following combination:
. Meets the symptom criteria of Contact Lens Dry Eye Questionnaire (CLDEQ-8) score ≥12
. And they show 1 of the following 2 signs:
. Have a systemic condition that in the opinion of the investigator may affect a study outcome variable;+ \[+ Any potential exclusion will be reviewed with the Lead Investigator or Principal Investigator prior to final decision making.\]
. Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;