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N/A N=74 Randomized Double-blind Treatment

Clinical Evaluation of Reusable Soft Contact Lenses

Myopia

Enrolled (actual)
74
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Visual Acuity — -0.07; -0.13 logMAR

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Control Lenses (comfilcon A with current process) (Device); Test Lenses (comfilcon A with novel process) (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
CooperVision International Limited (CVIL)
Primary completion
Mar 2024

Outcome Measures

OutcomeResultp-value
PRIMARY
Visual Acuity
-0.07; -0.13

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.

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06119191). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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