A clinical trial to evaluate an investigational contact lens worn in an extended wear mode (7 days and 6 nights of extended wear)
- Conditions
- Health Condition 1: null- Vision Correction
- Registration Number
- CTRI/2011/06/001845
- Lead Sponsor
- Johnson and Johnson Vision Care Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 85
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method