Comparison of Clinical Performance of Two Monthly Replacement Toric Soft Contact Lenses

NCT06165627 | Completed Results FDA Device

• 1 other identifier: CLV201-P003
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this study is to assess the clinical performance of TOTAL30 for Astigmatism (T30fA) soft contact lenses with Biofinity Toric soft contact lenses.

Conditions

Ametropia; Astigmatism

Keywords

Contact lenses; Myopia

Outcome Measures

Primary Outcomes (1)

• Mean Distance Visual Acuity With Study Lenses at Day 30

  Visual Acuity (VA) was assessed for each eye individually with study lenses in place while reading letter charts. VA was recorded in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen VA (normal distance eyesight), with lower logMAR values representing better eyesight.

  Day 30 of each wear period. A wear period was 30 days [-1/+3 days] according to randomization assignment.

Study Arms (2)

T30fA, then Biofinity Toric

OTHER

Lehfilcon A toric contact lenses worn in Period 1, followed by comfilcon A toric contact lenses worn in Period 2, as randomized. The study lenses will be worn bilaterally (in both eyes) during waking hours for at least 12 hours per day during each wear period (30 days \[-1/+3\] according to randomization assignment). Study lenses will be removed daily for cleaning and disinfection with CLEAR CARE Cleaning \& Disinfecting Solution.

Device: Lehfilcon A toric contact lenses; Device: Comfilcon A toric contact lenses; Device: CLEAR CARE

Biofinity Toric, then T30fA

OTHER

Comfilcon A toric contact lenses worn in Period 1, with lehfilcon A toric contact lenses worn in Period 2, as randomized. The study lenses will be worn bilaterally (in both eyes) during waking hours for at least 12 hours per day during each wear period (30 days \[-1/+3\] according to randomization assignment). Study lenses will be removed daily for cleaning and disinfection with CLEAR CARE Cleaning \& Disinfecting Solution.

Device: Lehfilcon A toric contact lenses; Device: Comfilcon A toric contact lenses; Device: CLEAR CARE

Interventions

Lehfilcon A toric contact lenses DEVICE

Commercially available soft contact lenses worn as indicated

Also known as: TOTAL30™ for Astigmatism, T30fA

Biofinity Toric, then T30fA; T30fA, then Biofinity Toric

Comfilcon A toric contact lenses DEVICE

Commercially available soft contact lenses) worn as indicated

Also known as: Biofinity® Toric, Biofinity Toric

Biofinity Toric, then T30fA; T30fA, then Biofinity Toric

CLEAR CARE DEVICE

Commercially available hydrogen peroxide-based solution for daily cleaning and disinfection of contact lenses used as indicated

Also known as: CLEAR CARE® Cleaning & Disinfecting Solution

Biofinity Toric, then T30fA; T30fA, then Biofinity Toric

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Successful wearer of toric soft contact lenses in both eyes for a minimum of 5 days per week and at least 12 hours per day during the past 3 months;
• Best corrected distance visual acuity (as determined by manifest refraction at screening) better than or equal to 0.10 logMAR in each eye;
• Willing and able to wear the study lenses as specified in the protocol;

You may not qualify if:

• Biomicroscopy findings at screening that are moderate (Grade 3) or higher and/or corneal vascularization that is mild (Grade 2) or higher; presence of corneal infiltrates;
• Monovision and multifocal contact lens wearers;
• Habitual Biofinity Toric soft contact lens wearers, daily disposable contact lens wearers, and Alcon Toric contact lens wearers in the past 3 months prior to consent;
• Wearing habitual contact lenses in extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (5)

Kurata Eye Care Center

Los Angeles, California, 90012, United States

Location

Elsa Pao, OD

Oakland, California, 94607, United States

Location

Pacific Rims Optometry

San Francisco, California, 94127, United States

Location

Vision Health Institute

Orlando, Florida, 32803, United States

Location

ProCare Vision Center

Granville, Ohio, 43023, United States

Location

MeSH Terms

Conditions

Refractive Errors; Astigmatism; Myopia

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: Sr. Clinical Project Lead, Vision Care
• Organization: Alcon Research, LLC

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Clinical Trial Lead, Vision Care

  Alcon Research, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: December 11, 2023
• Study Start: January 23, 2024
• Primary Completion: May 12, 2024
• Study Completion: May 12, 2024
• Last Updated: May 29, 2025
• Results First Posted: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)