Clinical Performance of Verofilcon A Toric Contact Lenses
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorSouthern College of Optometry
About this trial
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.
\[primary hypothesis or outcome measure 2\]? Contact lens dry eye-8 scores will be less than 12 indicating high levels of comfort after one month of wear.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Total 30 multi foric contact lenses
DeviceParticipants will be refit into total 30 contact lenses
Treatment groups
32 Participants
are divided into 1 treatment groupGroup A: TOTAL30 Multifocal Toric contact lensesExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Visual acuity scores
This will be a prospective study to understand if reusable silicone hydrogel toric CL wearers who are presbyopic can be successfully refit into Total30 MFT CLs VAS scores will be judged from -50 to positive 50 with positive numbers being more comfortable and 0 being neutral.
Time frame
1 monthSecondary outcomes
1
Contact lens dry eye 8 questionnaire scores
Proportion of reusable silicone hydrogel toric CL wearers who have asymptomatic Contact Lens Dry Eye-8 (CLDEQ-8; scores \<12) scores one month after wearing Total30 MFT CL
Time frame
1 month2
Comfort VAS
Comfort VAS after application and at 8, 12, and 16 hours of wear on Day 1 (1st full day), Day14, and Day 29 via text.
Time frame
Day 1, Day 14 and day 29 text messagesSponsors and contacts
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Source ClinicalTrials.gov