Evaluation of Approved Contact Lenses (CR-6657)
ConditionVisual Acuity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-39
SponsorJohnson & Johnson Vision Care, Inc.
About this trial
This is a prospective, multi-site, bilateral, 2-week dispensing, randomized, controlled, single-masked (subjects), 2x2 crossover study to evaluate visual acuity.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
Appear able and willing to adhere to the instructions set forth in this clinical protocol
Be between 18 and 39 (inclusive) years of age at the time of screening.
By self-report, habitually wear reusable spherical (not toric or multifocal) silicone hydrogel contact lenses in both eyes in a daily wear modality (i.e., not extended wear). Habitual wear is defined as a self-reported minimum of 6 hours of wear per day and 5 days per week during the past 30 days.
Disqualifiers
None
Trial design
Design model
Crossover
Treatments tested in this trial
Test (Senofilcon A)
DeviceTest Lens
Control (Serafilcon A)
DevicePrecision7®
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Test/ControlExperimental treatment 2 interventions
Group B: Control/TestExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Binocular High Luminance, Low Contrast (HLLC) Distance (4 meters) Visual Acuity (logMAR) at 2-week Follow-up
Time frame
At 2-week follow-upSponsors and contacts
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Source ClinicalTrials.gov