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

NCT05211739 | Completed Results FDA Device

• 1 other identifier: CLV201-C002
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 7

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.

Conditions

Refractive Errors; Astigmatism

Keywords

Contact Lenses

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

LID205255 Toric, then Biofinity Toric

OTHER

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; Device: Comfilcon A toric contact lenses; Device: CLEAR CARE

Biofinity Toric, then LID205255 Toric

OTHER

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; Device: Comfilcon A toric contact lenses; Device: CLEAR CARE

Interventions

Lehfilcon A toric contact lenses DEVICE

FDA-cleared silicone hydrogel toric contact lenses used as indicated

Also known as: LID205255 Toric

Biofinity Toric, then LID205255 Toric; LID205255 Toric, then Biofinity Toric

Comfilcon A toric contact lenses DEVICE

Commercially available silicone hydrogel toric contact lenses used as indicated

Also known as: Biofinity Toric, CooperVision® Biofinity® Toric

Biofinity Toric, then LID205255 Toric; LID205255 Toric, then Biofinity Toric

CLEAR CARE DEVICE

Hydrogen peroxide-based contact lens cleaning and disinfecting solution

Biofinity Toric, then LID205255 Toric; LID205255 Toric, then Biofinity Toric

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (7)

Sabal Eye Care

Longwood, Florida, 32779, United States

Location

Drs. Giedd, P.A.

Maitland, Florida, 32751, United States

Location

Vision Health Institute

Orlando, Florida, 32803, United States

Location

Kannarr Eye Care LLC

Pittsburg, Kansas, 66762, United States

Location

Fischer Laser Eye Center

Willmar, Minnesota, 56201, United States

Location

SUNY College of Optometry Clinical Vision Research Center

New York, New York, 10036, United States

Location

West Bay Eye Associates

Warwick, Rhode Island, 02888, United States

Location

MeSH Terms

Conditions

Refractive Errors; Astigmatism

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: Clinical Project Lead, CRD Vision Care
• Organization: Alcon Research, LLC

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Clinical Trial Lead, CRD Vision Care

  Alcon Research, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2022
• First Posted: January 27, 2022
• Study Start: February 15, 2022
• Primary Completion: June 23, 2022
• Study Completion: June 23, 2022
• Last Updated: June 27, 2023
• Results First Posted: June 27, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)