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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Ametropia, Astigmatism

Intervention / Treatment
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* Device: Lehfilcon A toric contact lenses
* Device: Comfilcon A toric contact lenses
* Device: CLEAR CARE


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Successful wearer of toric soft contact lenses in both eyes for a minimum of 5 days per week and 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 20/25 Snellen 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: T30fA, then Biofinity Toric<br>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<br>* Commercially available soft contact lenses worn as indicated<br>* Other names: T30fA;Device: Comfilcon A toric contact lenses<br>* Commercially available soft contact lenses) worn as indicated<br>* Other names: Biofinity Toric;Device: CLEAR CARE<br>* Commercially available hydrogen peroxide-based solution for daily cleaning and disinfection of contact lenses used as indicated<br>* Other names: CLEAR CARE® Cleaning & Disinfecting Solution;|
| Other: Biofinity Toric, then T30fA<br>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<br>* Commercially available soft contact lenses worn as indicated<br>* Other names: T30fA;Device: Comfilcon A toric contact lenses<br>* Commercially available soft contact lenses) worn as indicated<br>* Other names: Biofinity Toric;Device: CLEAR CARE<br>* Commercially available hydrogen peroxide-based solution for daily cleaning and disinfection of contact lenses used as indicated<br>* Other names: CLEAR CARE® Cleaning & Disinfecting Solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance VA with study lenses at Day 30 | Visual Acuity (VA) will be assessed for each eye individually with study lenses in place while reading letter charts. VA will be 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 is 30 days [-1/+3 days] according to randomization assignment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contact lenses, Myopia