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

Not Applicable

Completed

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

• Registration Number: NCT05211739
• Lead Sponsor: Alcon Research

Brief Summary

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.

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 Timeline

• Study First Submitted: 2022-01-14
• Study First Submitted QC: 2022-01-14
• Study First Posted: 2022-01-27
• Study Start: 2022-02-15
• Primary Completion: 2022-06-23
• Study Completion: 2022-06-23
• Status Verified: 2023-06
• Results First Submitted: 2023-06-05
• Results First Submitted QC: 2023-06-26
• Last Update Submitted: 2023-06-26
• Results First Posted: 2023-06-27
• Last Update Posted: 2023-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Biofinity Toric, then LID205255 Toric	CLEAR CARE	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.
Biofinity Toric, then LID205255 Toric	Lehfilcon A toric contact lenses	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.
Biofinity Toric, then LID205255 Toric	Comfilcon A toric contact lenses	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.
LID205255 Toric, then Biofinity Toric	Lehfilcon A toric contact lenses	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.
LID205255 Toric, then Biofinity Toric	Comfilcon A toric contact lenses	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.
LID205255 Toric, then Biofinity Toric	CLEAR CARE	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.

Primary Outcome Measures

Name	Time	Method
Distance Visual Acuity (VA) With Study Lenses	Day 1 and Day 30, each wear period (approximately 30 days)	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.

Trial Locations

Locations (7)

Sabal Eye Care; 🇺🇸 Longwood, Florida, United States

Fischer Laser Eye Center; 🇺🇸 Willmar, Minnesota, United States

Drs. Giedd, P.A.; 🇺🇸 Maitland, Florida, United States

West Bay Eye Associates; 🇺🇸 Warwick, Rhode Island, United States

Kannarr Eye Care LLC; 🇺🇸 Pittsburg, Kansas, United States

SUNY College of Optometry Clinical Vision Research Center; 🇺🇸 New York, New York, United States

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