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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.](streamdown:incomplete-link)
TOTAL30® Multifocal Toric contact lenses (CLs) are a 1-month, silicone hydrogel (lehfilcon A), studies have likewise found the lehfilcon A material to provides a comfortable wearing experience for the full life of the CL and for the full CL wear day.1 While initial TOTAL30 data are promising, the literature currently lacks data directly related to the Total30 MFT design and a targeted study aimed at evaluating how Total30 MFT performs with regards to overall comfort, vision, and satisfaction for those who are previous reusable toric CL wearers and are now presbyopic. This transition could be particularly important for patients who are presbyopic and astigmatic given that these two patients groups tend to struggle more with CLs than spherical CL wearers. Thus, the purpose of this work is to determine Total30 MFT overall comfort, vision, willingness to remain in CLs after the study, and satisfaction for those who currently wear reusable silicone hydrogel toric CLs and are now presbyopic. These data will provide valuable information to partitioners for patient educational purposes, and it will provide credence for refitting presbyopic patients who have astigmatism into Total30 MFT, especially after the onset of presbyopia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TOTAL30 Multifocal Toric contact lenses | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total 30 multi foric contact lenses | Device | Participants will be refit into total 30 contact lenses |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 month |
| Comfort VAS |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chris Lievens, OD | Contact | (901) 722-3200 | clievens@sco.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Southern College of Optometry | Recruiting | Memphis | Tennessee | 38104 | United States |
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| ID | Term |
|---|---|
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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Previous reusable soft contact lens wearers will be refit into total 30 mft contact lenses;
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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.
| Day 1, Day 14 and day 29 text messages |