To Evaluate the Performance of Total 30 (Lehifilcon A) Contact Lenses in Patients Using Digital D… (NCT06317038) | Clinical Trial Compass
CompletedNot Applicable
To Evaluate the Performance of Total 30 (Lehifilcon A) Contact Lenses in Patients Using Digital Devices for Greater Than 8 Hours Per Day 5 Days Per Week Based on Subjective Reported Data.
United States35 participantsStarted 2024-03-31
Plain-language summary
To evaluate the performance of Total 30® (lehfilcon A) contact lenses in patients using digital devices for greater than 8 hours per day 5 days per week based on subjective reported data.
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:
* Adult patients aged 18-40 of any sex and any race.
* Reports habitually using digital device usage (phone, Ipad, computer, social media, video streaming) for 8 hours or more per day 5 days per week with plans to continue the habit throughout the study.
* Wearing contact lenses for at least 13 hours daily 5 days per week.
* Spherical refractive error between -11.00 D and +6.00D with \< -0.75 D of astigmatism.
* Willing to comply with the protocol instructions.
* Has read (or has had read to), understood, and signed an Informed Consent.
* Willing to not use any artificial tears, rewetting drops or dry eye treatments during the study.
Exclusion Criteria:
* Active ocular infection or ocular inflammatory disease.
* Presbyopic or pre-presbyopic that have a measured add power for reading.
* Current Total 30 contact lens wearer.
* Anterior basement membrane dystrophy or history of recurrent erosion syndrome or topographical abnormalities that might indicate ectasia or other corneal degenerative conditions.
* Current or previous diagnosis of dry eye disease; currently using a dry eye treatment including but not limited to artificial tears, rewetting drops or prescription treatments.
* History of severe / serious ocular pathology or other medical conditions that could result in an inability to safely complete the study.
* Participation by the patient in any other investigational study within the past 30 days.
* Unlikely to comply with protocol instructions for …
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
Likert question about comfort satisfaction while wearing Total 30 contact lenses on a typical day (> 13 hours of daily wear) after 1 month of wear and heavy digital device usage (>8 hours daily wear).