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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.
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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:
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
Primary purpose
Allocation
Interventional model
Masking
77 participants in 2 patient groups
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Central trial contact
Cameron Postnikoff, PhD FAAO
Data sourced from clinicaltrials.gov
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