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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06469242
Other study ID # CLM234-C001
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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.
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