Clinical Evaluation of Reusable Soft Contact Lenses

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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

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)

Trial contacts and locations

0

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Central trial contact

Cameron Postnikoff, PhD FAAO

Data sourced from clinicaltrials.gov

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