The Clinical Performance of Two Reusable Silicone Hydrogel Contact Lenses

Not Applicable

Completed

Conditions: Refractive Ametropia

Interventions: Device: Serafilcon A contact lenses
Device: Senofilcon A contact lenses
Device: CLEAR CARE

Registration Number: NCT05766787

Lead Sponsor: Alcon Research

Brief Summary: The purpose of this study is to assess the clinical performance of two reusable silicone hydrogel contact lenses when worn on a daily wear basis.

Detailed Description: In this crossover study, subjects will wear each lens product for approximately 14 days and attend 7 scheduled visits. The expected overall duration of exposure to the study products is approximately 28 days.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 190

Inclusion Criteria

Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months.
Best Corrected Visual Acuity (BCVA) of 20/25 Snellen (0.10 logMAR) or better in each eye.
Willing to stop wearing habitual contact lenses for the duration of study participation.
Other protocol-specific inclusion criteria may apply.

Exclusion Criteria

Any eye infection, inflammation, abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the investigator.
Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the investigator.
Habitual wear of AOHP contact lenses.
Habitual wear of any daily disposable contact lenses.
Other protocol-specified exclusion criteria may apply.

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
LID022821, then AOHP	Serafilcon A contact lenses	Serafilcon A contact lenses worn first, with senofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for approximately 14 days. CLEAR CARE will be used for daily cleaning and disinfection.
LID022821, then AOHP	Senofilcon A contact lenses	Serafilcon A contact lenses worn first, with senofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for approximately 14 days. CLEAR CARE will be used for daily cleaning and disinfection.
AOHP, then LID022821	Serafilcon A contact lenses	Senofilcon A contact lenses worn first, with serafilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for approximately 14 days. CLEAR CARE will be used for daily cleaning and disinfection.
AOHP, then LID022821	Senofilcon A contact lenses	Senofilcon A contact lenses worn first, with serafilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for approximately 14 days. CLEAR CARE will be used for daily cleaning and disinfection.
LID022821, then AOHP	CLEAR CARE	Serafilcon A contact lenses worn first, with senofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for approximately 14 days. CLEAR CARE will be used for daily cleaning and disinfection.
AOHP, then LID022821	CLEAR CARE	Senofilcon A contact lenses worn first, with serafilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for approximately 14 days. CLEAR CARE will be used for daily cleaning and disinfection.

Primary Outcome Measures

Name	Time	Method
Least Squares Mean Distance VA With Study Lenses at Week 1	Week 1 of each lens product worn during the corresponding crossover period	Visual acuity (VA) was assessed for each eye individually with study lenses in place using logarithmic of the Minimum Angle of Resolution (logMAR) reading charts. LogMAR values typically range from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal distance visual acuity), with a negative value denoting better than 20/20 visual acuity.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (15): Pacific Rims Optometry
🇺🇸
San Francisco, California, United States
Tallahassee Eye Center
🇺🇸
Tallahassee, Florida, United States
Kurata Eyecare Center
🇺🇸
Los Angeles, California, United States
Heart of America Eye Care
🇺🇸
Shawnee Mission, Kansas, United States
Optometry Group, PLLC
🇺🇸
Memphis, Tennessee, United States
Vision Health Institute
🇺🇸
Orlando, Florida, United States
Dr. Elsa Pao, OD
🇺🇸
Oakland, California, United States
Omega Vision Center P.A.
🇺🇸
Longwood, Florida, United States
Kindred Optics at Maitland Vision
🇺🇸
Maitland, Florida, United States
The Eye Doctors Inc
🇺🇸
Eden Prairie, Minnesota, United States
Complete Eye Care of Medina
🇺🇸
Medina, Minnesota, United States
SUNY College of Optometry Clinical Vision Research Center
🇺🇸
New York, New York, United States
ProCare Vision Centers, Inc.
🇺🇸
Granville, Ohio, United States
West Bay Eye Associates
🇺🇸
Warwick, Rhode Island, United States
Total Eye Care PA
🇺🇸
Memphis, Tennessee, United States