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OpenTrials
Completed

NCT Number: NCT06165627

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kurata Eye Care Center, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lehfilcon A toric contact lenses

Device

Commercially available soft contact lenses worn as indicated

Other names: TOTAL30™ for Astigmatism, T30fA

Comfilcon A toric contact lenses

Device

Commercially available soft contact lenses) worn as indicated

Other names: Biofinity® Toric, Biofinity Toric

CLEAR CARE

Device

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

Other names: CLEAR CARE® Cleaning & Disinfecting Solution

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 11, 2023
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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