Clinical Performance of Verofilcon A Toric Contact Lenses

NCT07586982 | Recruiting DMC FDA Device

• 1 other identifier: IRB00006763-Total30MFT
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Contact Lenses; Presbyopia

Keywords

Optometry; Contact lens comfort

Outcome Measures

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.

  1 month

Secondary Outcomes (2)

• Contact lens dry eye 8 questionnaire scores

  1 month

• Comfort VAS

  Day 1, Day 14 and day 29 text messages

Study Arms (1)

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

Device: Total 30 multi foric contact lenses

Interventions

Total 30 multi foric contact lenses DEVICE

Participants will be refit into total 30 contact lenses

TOTAL30 Multifocal Toric contact lenses

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Southern College of Optometry: lead

Study Sites (1)

The Southern College of Optometry

Memphis, Tennessee, 38104, United States

RECRUITING

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Central Study Contacts

Chris Lievens, OD

CONTACT

(901) 722-3200; clievens@sco.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Previous reusable soft contact lens wearers will be refit into total 30 mft contact lenses;

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: May 14, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 14, 2026

Record last verified: 2026-05

Locations

US (1)