Health Condition 1: null- Vision Correction â??Ametropic
Conditions
Interventions
Intervention1: Investigational Contact Lens Materials EC0.2, EC1.2 and EC2.2: One contact lens per eye will be worn during the day. At the end of each days wear, each contact lens will be removed, cle
Sponsors
Johnson and Johnson Vision Care Inc
Eligibility
Inclusion criteria
Inclusion criteria: A. The subject must be between 18 and 39 years of age. B. The subject must be able to read and understand English. C. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form. This should be recorded on the Case Report Form (CRF). D. The subject must not have been a participant in a contact lens or contact lens solution study / investigation in the previous 7 days. E. The subject must be willing to wear the study lenses for at least 6 hours per day, 7 days per week (e.g. does not regularly swim more than once a week) F. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. G. The subjectâ??s subjective refraction must result in a vertex corrected spherical contact lens prescription in the range of -1.00D to -4.50D in each eye. H. The subjectâ??s refractive astigmatism must be less than or equal to -1.00D in both eyes. I. The subject must have best corrected visual acuity of 20/30 (6/9) or better in each eye. J. The subject must require a visual correction in both eyes (no monofit or monovision allowed). K. The subject must have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having: K1. No amblyopia. K2. No evidence of lid abnormality or infection (including blepharitis/meibomitis). K3. No conjunctival abnormality or infection. K4. No clinically significant slit lamp findings (i.e. stromal edema, vascularization, corneal scaring, infiltrates or abnormal opacities). K5. No other active ocular disease.
Exclusion criteria
Exclusion criteria: A. Any ocular or systemic allergies or diseases that may interfere with contact lens wear. B. Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. C. Clinically significant (Grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear. D. Clinically significant (Grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear. E. Any ocular infection. F. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. G. Pregnancy or lactation (subjects who become pregnant during the study will be discontinued). H. No extended wear in the last 3 months. I. Diabetes. J. Infectious diseases (e.g. hepatitis, tuberculosis) or an immunosuppressive disease (e.g. HIV). K. Has had refractive surgery. L. Has had eye injury/surgery within 8 weeks immediately prior to enrolment for this study. M. Abnormal lacrimal secretions. N. Employee of VRF (investigational site) with direct involvement in CR-5146 or family member of an employee of VRF (investigational site) with direct involvement in CR-5146.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Corneal Staining (type) 2. Limbal and bulbar conjunctival redness 3. Lens movement (push-up) Timepoint: One Month of Lens Wear | — |
Secondary
| Measure | Time frame |
|---|---|
| n/aTimepoint: n/a | — |
Countries
India
Contacts
Public ContactRanganath R Raja
Johnson and Johnson Limited
Outcome results
None listed