Health Condition 1: null- Vision Correction
Conditions
Interventions
Intervention1: galyfilcon A Contact Lens with Silver: One fresh pair of contact lenses worn weekly and replaced
Control Intervention1: NIL: NIL
Sponsors
Johnson and Johnson Vision Care Inc
Eligibility
Inclusion criteria
Inclusion criteria: A.Be between 18 and 39 years of age. B.Require a visual correction in both eyes (Monovision not allowed) C.Require a soft contact lens spherical correction between -0.50 and -5.75D in both eyes. D.Have an astigmatic correction less than 1.50D in both eyes. E.Be able to regularly wear the lenses on a 7 day/6 night extended wear basis (e.g. does not regularly swim more than once a week) F.Be correctable to a visual acuity of 20/30 or better in each eye with spherical distance correction. G.Have normal eyes with no evidence of abnormality or disease.
Exclusion criteria
Exclusion criteria: A.Requires concurrent ocular medication. B.Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear. C.Clinically significant (Grade 3 or 4) slit lamp findings including corneal edema, corneal vascularization, corneal staining, tarsal abnormalities, bulbar injection, or any other abnormality of the cornea that would contraindicate contact lens wear. D.Is currently or has previously worn any hard PMMA or RGP contact lenses. E.Known hypersensitivity to silver, silver ions or silver containing compounds.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| First serious and significant Corneal infiltrative event with an investigational antimicrobial contact lens evaluated over a six-month wear period.Timepoint: Events within six-month wear period. | — |
Secondary
| Measure | Time frame |
|---|---|
| NILTimepoint: NIL | — |
Countries
Australia, India
Contacts
Public ContactRanganath R Raja
Johnson and Johnson Limited
Outcome results
None listed