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

Astigmatism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05211739
• Other study ID #: CLV201-C002
• Status: Completed
• Phase: N/A
• Start date: February 15, 2022
• Est. completion date: June 23, 2022

Study information

• Verified date: June 2023
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: June 23, 2022
• Est. primary completion date: June 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Astigmatism
• Refractive Errors

Intervention

Device:
• Lehfilcon A toric contact lenses
FDA-cleared silicone hydrogel toric contact lenses used as indicated
• Comfilcon A toric contact lenses
Commercially available silicone hydrogel toric contact lenses used as indicated
• CLEAR CARE
Hydrogen peroxide-based contact lens cleaning and disinfecting solution

Locations

Country	Name	City	State
United States	Sabal Eye Care	Longwood	Florida
United States	Drs. Giedd, P.A.	Maitland	Florida
United States	SUNY College of Optometry Clinical Vision Research Center	New York	New York
United States	Vision Health Institute	Orlando	Florida
United States	Kannarr Eye Care LLC	Pittsburg	Kansas
United States	West Bay Eye Associates	Warwick	Rhode Island
United States	Fischer Laser Eye Center	Willmar	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)