Total30 for Astigmatism Contact Lenses (NCT06052046) | Clinical Trial Compass
CompletedNot Applicable
Total30 for Astigmatism Contact Lenses
United States48 participantsStarted 2023-10-15
Plain-language summary
Determine if Total30 for Astigmatism contact lenses (CLs) provide a comfortable wearing experience all day. CL discomfort affects most CL wearers with discomfort consistently topping the reasons why established CL wearers drop out of CLs. In fact, studies have consistently found that the frequency of CL dropout is around 20% with this dropout frequency staying relatively stable over the past 20 plus years. This static frequency of CL dropout is surprising since there have been a number of dramatic soft CL innovations during this time frame (e.g., widely available daily disposable CLs, silicone hydrogel CL materials with high oxygen transmissibility, new CL surface coatings).
Who can participate
Age range
18 Years – 45 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:
* 18- to 45-year-old
* Visual acuity 20/20 or better
* Contact Lens Dry Eye Questionnaire \[CLDEQ\]-8 scores \<10
* Willing to wear Total30 for Astigmatism CLs
* Have a smart phone with text messaging capabilities
* Astigmatism ranging from 0.75 D to 2.50 D in each eye
* Regularly worn 2 week or monthly CLs within the past 6 months
* Current CL wearer
* Glasses prescription that is less than 2 years old
* Willing to start wearing their CLs between 6:00 AM and 8:00 AM and wear their CLs until 11:00 PM each day text messaging data is collected
Exclusion Criteria:
* Current or past hard CL wearers
* A known systemic health condition that is thought to alter tear film physiology
* A history of viral eye disease
* A history of ocular surgery
* A history of severe ocular trauma
* Have an active ocular infection or inflammation
* Currently using isotretinoin-derivatives or ocular medications
* Currently using rewetting drops or artificial tears
* Pregnant or breast feeding
* Willing to discontinue usage of current toric CLs one week prior to the initial visit
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.