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

May 27, 2025 updated by: Alcon Research
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Subjects will be expected to attend 5 office visits and will be dispensed study lenses (per randomization sequence) for 30-day duration of bilateral wear with each study lens (approximately 60 days of lens wear). The total duration of the subject's participation in the study will be approximately 74 days.

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90012
        • Kurata Eye Care Center
      • Oakland, California, United States, 94607
        • Elsa Pao, OD
      • San Francisco, California, United States, 94127
        • Pacific Rims Optometry
    • Florida
      • Orlando, Florida, United States, 32803
        • Vision Health Institute
    • Ohio
      • Granville, Ohio, United States, 43023
        • ProCare Vision Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • 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;
  • Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

  • 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;
  • Other protocol-specified exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: T30fA, then Biofinity Toric
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
Commercially available soft contact lenses worn as indicated
Other Names:
  • T30fA
  • TOTAL30™ for Astigmatism
Device: Comfilcon A toric contact lenses
Commercially available soft contact lenses) worn as indicated
Other Names:
  • Biofinity Toric
  • Biofinity® Toric
Device: CLEAR CARE
Commercially available hydrogen peroxide-based solution for daily cleaning and disinfection of contact lenses used as indicated
Other Names:
  • CLEAR CARE® Cleaning & Disinfecting Solution
Other: Biofinity Toric, then T30fA
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
Commercially available soft contact lenses worn as indicated
Other Names:
  • T30fA
  • TOTAL30™ for Astigmatism
Device: Comfilcon A toric contact lenses
Commercially available soft contact lenses) worn as indicated
Other Names:
  • Biofinity Toric
  • Biofinity® Toric
Device: CLEAR CARE
Commercially available hydrogen peroxide-based solution for daily cleaning and disinfection of contact lenses used as indicated
Other Names:
  • CLEAR CARE® Cleaning & Disinfecting Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Distance Visual Acuity With Study Lenses at Day 30
Time Frame: Day 30 of each wear period. A wear period was 30 days [-1/+3 days] according to randomization assignment.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Investigators

  • Study Director: Clinical Trial Lead, Vision Care, Alcon Research, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 23, 2024

Primary Completion (Actual)

May 12, 2024

Study Completion (Actual)

May 12, 2024

Study Registration Dates

First Submitted

December 4, 2023

First Submitted That Met QC Criteria

December 4, 2023

First Posted (Actual)

December 11, 2023

Study Record Updates

Last Update Posted (Actual)

May 29, 2025

Last Update Submitted That Met QC Criteria

May 27, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLV201-P003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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