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Clinical Performance of Verofilcon A Toric Contact Lenses

RecruitingNAAges 18 Years - 40 YearsAllSouthern College of Optometry
NCT07586982 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to \[primary purpose: is to determine if Total30 Multi focal toric conntact lensesare comfortable and the willigness for those who have previously worn reusable toric contact lenses are willing to stay in Total30 MFT after 1 month of wear during the duration of the study. Healthy previous reusable toric contact lens weareres will be refit into total30 MFT contact lenses and will be asked to gauge their comfort while wearing the lenses. Healthy adult participants who are presybyopic between the ages of 18-40 can participant, sex and gender are not disqualifiers unless the participant is pregnant or breast feeding. The main question\[s\] it aims to answer \[is/are\] \[primary hypothesis or outcome measure 1Proportions of toric CL wearers who have positive visual acuity scores in comfort and vision after one month of wear. \[primary hypothesis or outcome

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📋 Eligibility rules (as published)
Inclusion Criteria: * Adults, ≥40-year-old, CL wearers with best-corrected 20/20 distance visual acuity or better. * Requiring +0.75 ADD or more at standard near distance of 40 cm. * Participants will be required to have worn reusable silicone hydrogel toric CLs in the past year and still at a minimum wearing the CLs occasionally without having significant discomfort or dryness. * All participants will be required to have a CLDEQ-8 score \<12. * Participants will be required to be able to wear Total 30MFT CLs (presbyopic plus astigmatism both ≥0.75D OD and OS). * Astigmatism ranging from 0.75 D to 2.50 D in each eye. * Participants will be required to wear the study CLs for ≥13 hours each day with no overnight wear. * Willing to wear study CLs for ≥16 hours on the Day 1 (1st full day), Day 14, and Day 29 when responses will be collected via text message. * Participants will be willing to wear the CL every day of the week. * Participants will be required to provide a glasses prescription that is less than 3 years old. * Visual acuity with habitual reusable silicone hydrogel toric CLs is 20/25 or better in each eye. Exclusion Criteria: * Have worn Total30 MFT in the past * Are past rigid CL wearers * Are currently wearing monovision CLs * Have a history of being diagnosed with dry eye or ocular allergies * Have known systemic health conditions that are thought to alter tear film physiology * Have a history of viral eye disease * Have a history of ocular surgery * Have a history of severe ocular trauma * Have a history of corneal dystrophies or degenerations * Have active ocular infection or inflammation * Are currently using isotretinoin-derivatives or ocular medications * Are pregnant or breast feeding
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What it tests

  • Total 30 multi foric contact lenses
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Where

1 site
The Southern College of Optometry
Memphis, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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