Clinical Performance Evaluation of Two Frequent Replacement Silicone Hydrogel Multifocal Toric Contact Lenses

Presbyopia Clinical Trial

Official title:

Clinical Performance Evaluation of Two Frequent Replacement Silicone Hydrogel Multifocal Toric Contact Lenses

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06461455
• Other study ID #: CLR624-C001
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: November 2024

Study information

• Verified date: June 2024
• Source: Alcon Research
• Contact: Alcon Call Center
• Phone: 1-888-451-3937
• Email: alcon.medinfo[@]alcon.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate on-eye clinical performance of the investigational contact lenses following 30 days of wear in the intended population.

Description:

Participants will be expected to attend 5 office visits for an individual duration of participation of approximately 64 days.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 82
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Key Inclusion Criteria:

• Habitual wearer of biweekly/monthly replacement soft multifocal or multifocal toric contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;

• Manifest cylinder equal to or greater than 0.75 diopter (D) in each eye at Screening;

• Willing to not use readers while wearing study contact lenses for duration of the study;

• Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

• Use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear;

• Wears habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;

• Monovision contact lens wearers and wearers of contact lens in one eye only;

• Other protocol-defined exclusion criteria may apply.

Related Conditions & MeSH terms

• Astigmatism
• Presbyopia

Intervention

Device:
• Lehfilcon A multifocal for astigmatism contact lenses
Investigational multifocal contact lenses for astigmatism
• Samfilcon A multifocal for astigmatism contact lenses
Commercially available multifocal contact lenses for astigmatism
• CLEAR CARE
Hydrogen peroxide-based contact lens cleaning and disinfection system

Locations

Country	Name	City	State
United States	Oculus Research, Inc.	Garner	North Carolina
United States	ProCare Vision Centers, Inc.	Granville	Ohio
United States	Drs. Giedd, P.A.	Maitland	Florida
United States	Optometry Group, PLLC	Memphis	Tennessee
United States	Dr.Elsa Pao, O.D	Oakland	California
United States	Vision Health Institute	Orlando	Florida
United States	Dawn M. Rakich, OD	San Antonio	Texas
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	Binocular visual acuity at distance (4 meters) at Day 30 with study lenses	High contrast, high illumination visual acuity (VA) will be assessed at a distance of 4 meters for both eyes together with study lenses in place. VA will be measured using letter charts and recorded in logarithm minimum angle of resolution (logMAR), with a logMAR value of 0 equating to 20/20 Snellen VA (normal distance eyesight) and lower logMAR values representing better eyesight.	Day 30 (-2/+1) of each wear period. A wear period is 30 days (-2/+1) according to randomization assignment.]