Clinical Performance of Two Frequent Replacement Silicone Hydrogel Multifocal Contact Lenses

Presbyopia Clinical Trial

Official title:

Clinical Performance of Two Frequent Replacement Silicone Hydrogel Multifocal Contact Lenses

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06469242
• Other study ID #: CLM234-C001
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: October 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 the on-eye multifocal clinical performance of investigational LID233309 contact lenses and Oasys multifocal (MF) contact lenses in a daily wear dispensing trial.

Description:

Subjects will be expected to attend 7 office visits for an individual duration of participation of 28 to 40 days.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 96
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Key Inclusion Criteria:

• Current wearer of biweekly/monthly replacement multifocal soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 6 months.

• Manifest cylinder equal to or less than 0.75 diopter (D) in each eye.

• Able to wear contact lenses within the available power range with a near ADD of +0.75 D to +2.50 D in each eye.

• Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

• Currently pregnant or lactating.

• History of amblyopia, strabismus, or binocular vision abnormalities.

• Habitual Oasys MF contact lens wearers or daily disposable contact lens wearers.

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

• Other protocol-defined exclusion criteria may apply.

Related Conditions & MeSH terms

• Presbyopia

Intervention

Device:
• Serafilcon A multifocal contact lenses
Investigational multifocal soft contact lenses
• Senofilcon A multifocal contact lenses
Commercially available multifocal soft contact lenses
• CLEAR CARE® Cleaning & Disinfecting Solution
Hydrogen peroxide-based contact lens cleaning and disinfection system

Locations

Country	Name	City	State
United States	ProCare Vision Centers, Inc.	Granville	Ohio
United States	Kurata Eyecare Center	Los Angeles	California
United States	Drs. Giedd, P.A.	Maitland	Florida
United States	Wesley Optometric Consulting	Medina	Minnesota
United States	Optometry Group, PLLC	Memphis	Tennessee
United States	Elsa Pao, OD	Oakland	California
United States	Vision Health Institute	Orlando	Florida
United States	Insight Research Clinic LLC	Powell	Ohio

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 Week 1	Visual Acuity (VA) will be assessed at a distance of 4 meters for both eyes together under high contrast, high illumination lighting 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.	Week 1 (Day 7 -0/+1 days) of each wear period. A wear period is 14 days (-0/+2 days) according to randomization assignment.