Clinical Performance of Two Frequent Replacement Silicone Hydrogel Multifocal Contact Lenses

Not Applicable

Completed

• Conditions: Presbyopia
• Interventions: Device: Serafilcon A multifocal contact lenses; Device: Senofilcon A multifocal contact lenses; Device: CLEAR CARE® Cleaning & Disinfecting Solution

• Registration Number: NCT06469242
• Lead Sponsor: Alcon Research

Brief 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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2024-06-17
• Study First Submitted QC: 2024-06-17
• Study First Posted: 2024-06-21
• Study Start: 2024-07-18
• Status Verified: 2024-10
• Primary Completion: 2024-10-08
• Study Completion: 2024-10-08
• Last Update Submitted: 2024-10-14
• Last Update Posted: 2024-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Oasys MF, then LID233309	Senofilcon A multifocal contact lenses	Senofilcon A multifocal contact lenses worn in Period 1, followed by serafilcon A multifocal contact lenses worn in Period 2, as randomized. The study lenses will be worn bilaterally (in both eyes) during waking hours for at least 10 hours per day, each wear period \[14 days (-0/+2)\]. Study lenses will be removed daily for cleaning and disinfection with CLEAR CARE.
LID233309, then Oasys MF	Serafilcon A multifocal contact lenses	Serafilcon A multifocal contact lenses worn in Period 1, followed by senofilcon A multifocal contact lenses worn in Period 2, as randomized. The study lenses will be worn bilaterally (in both eyes) during waking hours for at least 10 hours per day, each wear period \[14 days (-0/+2)\]. Study lenses will be removed daily for cleaning and disinfection with CLEAR CARE.
LID233309, then Oasys MF	Senofilcon A multifocal contact lenses	Serafilcon A multifocal contact lenses worn in Period 1, followed by senofilcon A multifocal contact lenses worn in Period 2, as randomized. The study lenses will be worn bilaterally (in both eyes) during waking hours for at least 10 hours per day, each wear period \[14 days (-0/+2)\]. Study lenses will be removed daily for cleaning and disinfection with CLEAR CARE.
Oasys MF, then LID233309	Serafilcon A multifocal contact lenses	Senofilcon A multifocal contact lenses worn in Period 1, followed by serafilcon A multifocal contact lenses worn in Period 2, as randomized. The study lenses will be worn bilaterally (in both eyes) during waking hours for at least 10 hours per day, each wear period \[14 days (-0/+2)\]. Study lenses will be removed daily for cleaning and disinfection with CLEAR CARE.
Oasys MF, then LID233309	CLEAR CARE® Cleaning & Disinfecting Solution	Senofilcon A multifocal contact lenses worn in Period 1, followed by serafilcon A multifocal contact lenses worn in Period 2, as randomized. The study lenses will be worn bilaterally (in both eyes) during waking hours for at least 10 hours per day, each wear period \[14 days (-0/+2)\]. Study lenses will be removed daily for cleaning and disinfection with CLEAR CARE.
LID233309, then Oasys MF	CLEAR CARE® Cleaning & Disinfecting Solution	Serafilcon A multifocal contact lenses worn in Period 1, followed by senofilcon A multifocal contact lenses worn in Period 2, as randomized. The study lenses will be worn bilaterally (in both eyes) during waking hours for at least 10 hours per day, each wear period \[14 days (-0/+2)\]. Study lenses will be removed daily for cleaning and disinfection with CLEAR CARE.

Primary Outcome Measures

Name	Time	Method
Binocular visual acuity at distance (4 meters) at Week 1	Week 1 (Day 7 -0/+1 days) of each wear period. A wear period is 14 days (-0/+2 days) according to randomization assignment.	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.

Trial Locations

Locations (8)

Vision Health Institute; 🇺🇸 Orlando, Florida, United States

Kurata Eyecare Center; 🇺🇸 Los Angeles, California, United States

Elsa Pao, OD; 🇺🇸 Oakland, California, United States

Drs. Giedd, P.A.; 🇺🇸 Maitland, Florida, United States

Wesley Optometric Consulting; 🇺🇸 Medina, Minnesota, United States

ProCare Vision Centers, Inc.; 🇺🇸 Granville, Ohio, United States

Insight Research Clinic LLC; 🇺🇸 Powell, Ohio, United States

Optometry Group, PLLC; 🇺🇸 Memphis, Tennessee, United States