Clinical Performance of Verofilcon A Toric Contact Lenses

Clinical Performance of Verofilcon A Toric Contact Lenses in Satisfied Wearers of Senofilcon A Toric Contact Lenses With Blue Light Filtration

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.

Study Overview

• Status: Recruiting
• Conditions: Presbyopia; Contact Lenses
• Intervention / Treatment: Device: Total 30 multi foric contact lenses

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chris Lievens, OD; Phone Number: (901) 722-3200; Email: clievens@sco.edu

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38104
      • Recruiting
      • The Southern College of Optometry
      • Contact: Chris Lievens, OD; Phone Number: 9014815699; Email: clievens@sco.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TOTAL30 Multifocal Toric contact lenses; 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; Participants will be refit into total 30 contact lenses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Southern College of Optometry

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: May 7, 2026
• First Submitted That Met QC Criteria: May 7, 2026
• First Posted (Actual): May 14, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Optometry; Contact lens comfort
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia
• Other Study ID Numbers: IRB00006763-Total30MFT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes