Clinical Evaluation of Reusable Soft Contact Lenses

Not Applicable

Completed

Interventions: Device: Test Lenses (comfilcon A with novel process)
Device: Control Lenses (comfilcon A with current process)

Brief Summary: The purpose of this study was to confirm the clinical performance of a novel manufacturing process for comfilcon A contact lenses in habitual wearers over a one-month period of lens wear.

Detailed Description: This was a prospective, multiple day, double-masked (investigator and subject), randomized, bilateral re-fit parallel arm study comparing a Test Lens against an appropriate Control Lens. Participants were randomized to wear the Test or Control lens for 30±2 days.

Recruitment & Eligibility

Inclusion Criteria

Have had a self-reported oculo-visual examination in the last year.
Are at least 18 years of age and has full legal capacity to give their informed consent.
Have read and understood the informed consent letter.
Are willing and able to follow instructions and maintain the appointment schedule.
Have a contact lens spherical prescription between -0.50 D to -6.00 D (inclusive)
Are correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.
Have spectacle cylinder of ≤ 0.75 D in both eyes.
Is a habitual comfilcon A wearer and worn a comfilcon A lens for at least one month (minimum of 8 hours a day, 5 days per week)
Currently employ the use of a peroxide or multipurpose solution cleaning and disinfecting regimen in one of the following brand names:
- Bausch and Lomb BioTrue Multi-Purpose Solution
- Bausch and Lomb BioTrue Hydration Plus Multi-Purpose Solution
- Bausch and Lomb ReNu Advanced Formulation Multi-Purpose Solution
- Alcon Opti-Free Puremoist with Hydraglyde Multi-Purpose Solution
- Alcon Opti-Free Replenish Multi-Purpose Solution
- Alcon Clear Care Plus Hydrogen Peroxide Solution
- Acuvue RevitaLens Multi-Purpose Solution
Have clear corneas and no active ocular disease.
Have not worn habitual lenses for at least 12 hours before the baseline/screening examination
Are willing to wear the study contact lenses for at least 8 hours per day, 5 days per week

Exclusion Criteria

Have never worn contact lenses before.
Are currently wearing daily disposable contact lenses.
Have any systemic disease affecting ocular health.
Are using any systemic or topical medications that will affect ocular health.
Have any ocular pathology or abnormality that would affect the wearing of contact lenses.
Have any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
Are aphakic.
Have undergone corneal refractive surgery.
Are participating in any other type of eye related clinical or research study.
Require a change in lens power from more than 1 diopter as dictated by over-refraction with their habitual lens prescription.

Arm && Interventions

Group	Intervention	Description
Test Lenses	Test Lenses (comfilcon A with novel process)	Participants will wear Test Lenses for 4 weeks
Control Lenses	Control Lenses (comfilcon A with current process)	Participants will wear Control Lenses for 4 weeks

Primary Outcome Measures

Name	Time	Method
Visual Acuity	4 weeks	Monocular distance logMAR visual acuity at distance 4 meters under high illumination, high contrast conditions was measured at the 4 week timepoint of lens wear.

Secondary Outcome Measures

Name	Time	Method

Locations (5): ProCare Vision Center, Inc.
🇺🇸
Granville, Ohio, United States
Clinical Research Center, UC Berkeley
🇺🇸
Berkeley, California, United States
Clinical Optics Research Lab at IU School of Optometry
🇺🇸
Bloomington, Indiana, United States
SUNY College of Optometry Clinical Vision Research Center
🇺🇸
New York, New York, United States
Ohio State University College of Optometry
🇺🇸
Columbus, Ohio, United States