Clinical trial NCT06119191: Clinical Evaluation of Reusable Soft Contact Lenses
Official title: Clinical Evaluation of Comfilcon A Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2023-11-07
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Visual Acuity
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: Clinical Research Center, UC Berkeley
state: California
city: Bloomington
country: United States
facility: Clinical Optics Research Lab at IU School of Optometry
state: Indiana
city: New York
country: United States
facility: SUNY College of Optometry Clinical Vision Research Center
state: New York
city: Columbus
country: United States
facility: Ohio State University College of Optometry
state: Ohio
city: Granville
country: United States
facility: ProCare Vision Center, Inc.
state: Ohio
Study officials:
affiliation: Clinical Research Center, UC Berkeley
name: Meng C Lin, OD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: SUNY College of Optometry Clinical Vision Research Center
name: Josianne Manasse, OD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Optics Research Lab at IU School of Optometry
name: Peter Kollbaum, OD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: ProCare Vision Center, Inc.
name: Katherine Bickle, OD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ohio State University
name: Jennifer S Fogt, OD MS
role: PRINCIPAL_INVESTIGATOR
References: