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

Not Applicable

Completed

• Conditions: Ametropia; Astigmatism
• Interventions: Device: Lehfilcon A toric contact lenses; Device: Comfilcon A toric contact lenses; Device: CLEAR CARE

• Registration Number: NCT06165627
• Lead Sponsor: Alcon Research

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.

Study Timeline

• Study First Submitted: 2023-12-04
• Study First Submitted QC: 2023-12-04
• Study First Posted: 2023-12-11
• Study Start: 2024-01-23
• Primary Completion: 2024-05-12
• Study Completion: 2024-05-12
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-03
• Last Update Posted: 2024-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Biofinity Toric, then T30fA	Lehfilcon A toric contact lenses	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.
Biofinity Toric, then T30fA	Comfilcon A toric contact lenses	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.
T30fA, then Biofinity Toric	Lehfilcon A toric contact lenses	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.
T30fA, then Biofinity Toric	CLEAR CARE	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.
T30fA, then Biofinity Toric	Comfilcon A toric contact lenses	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.
Biofinity Toric, then T30fA	CLEAR CARE	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.

Primary Outcome Measures

Name	Time	Method
Distance VA with study lenses at Day 30	Day 30 of each wear period. A wear period is 30 days [-1/+3 days] according to randomization assignment)	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.

Trial Locations

Locations (5)

ProCare Vision Center; 🇺🇸 Granville, Ohio, United States

Kurata Eye Care Center; 🇺🇸 Los Angeles, California, United States

Pacific Rims Optometry; 🇺🇸 San Francisco, California, United States

Elsa Pao, OD; 🇺🇸 Oakland, California, United States

Vision Health Institute; 🇺🇸 Orlando, Florida, United States