N/A
N=74
Clinical Evaluation of Reusable Soft Contact Lenses
Myopia
Bottom Line
View on ClinicalTrials.gov: NCT06119191 ↗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
| Outcome | Result | p-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.
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.