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

NCT ID: NCT06165627

Last Updated: 2025-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-23
• Study Completion Date: 2024-05-12

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.

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.

Conditions

Ametropia; Astigmatism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: OTHER

Lehfilcon A toric contact lenses

Intervention Type: DEVICE

Commercially available soft contact lenses worn as indicated

Comfilcon A toric contact lenses

Intervention Type: DEVICE

Commercially available soft contact lenses) worn as indicated

CLEAR CARE

Intervention Type: DEVICE

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

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.

Group Type: OTHER

Lehfilcon A toric contact lenses

Intervention Type: DEVICE

Commercially available soft contact lenses worn as indicated

Comfilcon A toric contact lenses

Intervention Type: DEVICE

Commercially available soft contact lenses) worn as indicated

CLEAR CARE

Intervention Type: DEVICE

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

Interventions

Lehfilcon A toric contact lenses

Commercially available soft contact lenses worn as indicated

Intervention Type: DEVICE

Comfilcon A toric contact lenses

Commercially available soft contact lenses) worn as indicated

Intervention Type: DEVICE

CLEAR CARE

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

Intervention Type: DEVICE

Other Intervention Names

TOTAL30™ for Astigmatism; T30fA; Biofinity® Toric; Biofinity Toric; CLEAR CARE® Cleaning & Disinfecting Solution

Eligibility Criteria

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;

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trial Lead, Vision Care

Role: STUDY_DIRECTOR

Alcon Research, LLC

Locations

Kurata Eye Care Center

Los Angeles, California, United States

Elsa Pao, OD

Oakland, California, United States

Pacific Rims Optometry

San Francisco, California, United States

Vision Health Institute

Orlando, Florida, United States

ProCare Vision Center

Granville, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CLV201-P003

Identifier Type: -

Identifier Source: org_study_id