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

Astigmatism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06165627
• Other study ID #: CLV201-P003
• Status: Completed
• Phase: N/A
• Start date: January 23, 2024
• Est. completion date: May 12, 2024

Study information

• Verified date: June 2024
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: May 12, 2024
• Est. primary completion date: May 12, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Key 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.

Related Conditions & MeSH terms

• Ametropia
• Astigmatism
• Refractive Errors

Intervention

Device:
• Lehfilcon A toric contact lenses
Commercially available soft contact lenses worn as indicated
• Comfilcon A toric contact lenses
Commercially available soft contact lenses) worn as indicated
• CLEAR CARE
Commercially available hydrogen peroxide-based solution for daily cleaning and disinfection of contact lenses used as indicated

Locations

Country	Name	City	State
United States	ProCare Vision Center	Granville	Ohio
United States	Kurata Eye Care Center	Los Angeles	California
United States	Elsa Pao, OD	Oakland	California
United States	Vision Health Institute	Orlando	Florida
United States	Pacific Rims Optometry	San Francisco	California

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