North American Comfilcon A Clinical Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age8-75
SponsorCooperVision International Limited (CVIL)
About this trial
The main objective of this study is to demonstrate acceptable safety and effectiveness (performance) of comfilcon A Sphere, Toric, Multifocal, Toric Multifocal and Energys lenses, when used in the general population.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 8 to 75 years (inclusive).
Current wearer of the Comfilcon A sphere, toric, multifocal, toric multifocal or Energys contact lens for at least 12 months.
At least occasional overnight wear in the last 12 months.
Disqualifiers
None
Trial population
Female or male subjects aged 8 to 75 years who are established contact lens wearers. Screen and enrol approximately 182 participants wearing comfilcon A lenses with the aim of achieving at least 160 in the per protocol analysis cohort.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
comfilcon A Sphere lens
Device2 hours of wear
comfilcon A Toric lens
Device2 hours of wear
comfilcon A Multifocal lens
Device2 hours of wear
comfilcon A Multifocal Toric lens
Device2 hours of wear
comfilcon A Energys lens
Device2 hours of wear
Treatment groups
182 Participants
are divided into 5 treatment groupsGroup A: comfilcon A Sphere Lens Wearers1 intervention
Group B: comfilcon A Toric Lens Wearers1 intervention
Group C: comfilcon A Multifocal Lens Wearers1 intervention
Group D: comfilcon A Multifocal Toric Lens Wearers1 intervention
Group E: comfilcon A Energys Lens Wearers1 intervention
Trial outcomes
Primary outcomes
1
Visual Performance (Visual Acuity)
Visual Performance will be measured using logMAR * High contrast, high illumination distance VA * High contrast, high illumination near VA
Time frame
At the end of 2 hours of wear2
Incidence of contact lens-related adverse events
Incidence of contact lens-related adverse events will be recorded from subjects
Time frame
At the end of 2 hours of wearSponsors and contacts
Click on the lead sponsor to view all of their trials.
CooperVision International Limited (CVIL)
Lead sponsor
Centre for Ocular Research & Education, Canada
Collaborator
Source ClinicalTrials.gov