Clinical Assessment of a Daily Wear Monthly Replacement Silicone Hydrogel Toric Contact Lens

The purpose of this clinical study is to assess the clinical performance of an investigational toric soft contact lens compared to a commercially available toric contact lens in a crossover dispense trial when worn in a daily wear modality for 30 days, each study lens type.

Study Overview

• Status: Completed
• Conditions: Refractive Errors; Astigmatism
• Intervention / Treatment: Device: Lehfilcon A toric contact lenses; Device: Comfilcon A toric contact lenses; Device: CLEAR CARE

Detailed Description

Subjects will be randomized to 1 of 2 crossover wear sequences. Subjects will be expected to attend 5 office visits, for a total individual duration of participation in the study of approximately 60 days.

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Longwood, Florida, United States, 32779
      • Sabal Eye Care
    • Maitland, Florida, United States, 32751
      • Drs. Giedd, P.A.
    • Orlando, Florida, United States, 32803
      • Vision Health Institute
  • Kansas
    • Pittsburg, Kansas, United States, 66762
      • Kannarr Eye Care LLC
  • Minnesota
    • Willmar, Minnesota, United States, 56201
      • Fischer Laser Eye Center
  • New York
    • New York, New York, United States, 10036
      • SUNY College of Optometry Clinical Vision Research Center
  • Rhode Island
    • Warwick, Rhode Island, United States, 02888
      • West Bay Eye Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• Successful wearers of weekly/monthly toric soft contact lenses in both eyes for a minimum of 5 days per week and 10 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.
• Able to wear contact lenses within the range of available sphere & cylinder power and axes.
• Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

• Daily disposable contact lens wearers.
• Monovision and multifocal contact lens wearers.
• Habitual Biofinity Toric/Biofinity Toric XR contact lens wearers in the past 3 months prior to consent.
• Other protocol-defined exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: LID205255 Toric, then Biofinity Toric; Lehfilcon A toric contact lenses worn first, with comfilcon A toric contact lenses worn second, as randomized. Each product will be worn bilaterally (in both eyes) during waking hours for at least 5 days per week, with up to 10-12 hours wear time per day over a 30-day period. CLEAR CARE will be used for nightly contact lens cleaning and disinfection.	Device: Lehfilcon A toric contact lenses; FDA-cleared silicone hydrogel toric contact lenses used as indicated; Other Names: LID205255 Toric; Device: Comfilcon A toric contact lenses; Commercially available silicone hydrogel toric contact lenses used as indicated; Other Names: Biofinity Toric; CooperVision® Biofinity® Toric; Device: CLEAR CARE; Hydrogen peroxide-based contact lens cleaning and disinfecting solution
Other: Biofinity Toric, then LID205255 Toric; Comfilcon A toric contact lenses worn first, with lehfilcon A toric contact lenses worn second, as randomized. Each product will be worn bilaterally (in both eyes) during waking hours for at least 5 days per week, with up to 10-12 hours wear time per day over a 30-day period. CLEAR CARE will be used for nightly contact lens cleaning and disinfection.	Device: Lehfilcon A toric contact lenses; FDA-cleared silicone hydrogel toric contact lenses used as indicated; Other Names: LID205255 Toric; Device: Comfilcon A toric contact lenses; Commercially available silicone hydrogel toric contact lenses used as indicated; Other Names: Biofinity Toric; CooperVision® Biofinity® Toric; Device: CLEAR CARE; Hydrogen peroxide-based contact lens cleaning and disinfecting solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distance Visual Acuity (VA) With Study Lenses	Visual acuity (VA) was collected for each eye individually with study lenses in place using a letter chart. VA was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. No inferences were pre-specified for the primary effectiveness endpoint; therefore, no hypothesis testing was performed.	Day 1 and Day 30, each wear period (approximately 30 days)

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2022
• Primary Completion (Actual): June 23, 2022
• Study Completion (Actual): June 23, 2022

Study Registration Dates

• First Submitted: January 14, 2022
• First Submitted That Met QC Criteria: January 14, 2022
• First Posted (Actual): January 27, 2022

Study Record Updates

• Last Update Posted (Actual): June 27, 2023
• Last Update Submitted That Met QC Criteria: June 26, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Contact Lenses
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: CLV201-C002

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