Clinical Evaluation of Reusable Soft Contact Lenses

CooperVision

Status: Completed

Conditions: Myopia

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT06119191

CV-23-86

Details and patient eligibility

About

The purpose of this study is to confirm the clinical performance of a novel manufacturing process for comfilcon A contact lenses in habitual wearers.

Full description

This will be a prospective, multiple day, double (investigator and subject)-masked, randomized, bilateral re-fit parallel arm study comparing Test lenses against appropriate Control lenses. Participants will be randomized to wear either the Test or Control lenses, and the estimated duration of involvement is 4 months.

Enrollment: 77 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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77 participants in 2 patient groups

Control Lenses

Experimental group

Description:

Participants will wear Control Lenses for 4 weeks

Treatment:

Device: Control Lenses (comfilcon A with current process)

Test Lenses

Experimental group

Description:

Participants will wear Test Lenses for 4 weeks

Treatment:

Device: Test Lenses (comfilcon A with novel process)