Health Condition 1: null- Vision Correction â??Ametropic
Conditions
Interventions
Intervention1: senofilcon A (Approved contact Lens material): One fresh pair of contact lenses worn for 11(-/+2) days for a minimum of 6 hours per day
Control Intervention1: lotrafilcon B (approved co
Sponsors
Johnson and Johnson Vision Care Inc
Eligibility
Inclusion criteria
Inclusion criteria: A. The subject must read, understand English, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form. B. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. C. The subject must be 18 and less than 40 years of age. D. The subjectâ??s corrected spherical equivalent distance refraction must be in the range of -1.00 to -5.00 diopters in each eye with a visual acuity of 20/25 with provided study lens in each eye. E. The subject must have less than -1.00 diopters of cylindrical refraction. F. The subject must have best corrected visual acuity of 20/25 or better in each eye. G. The subject must be an adapted soft contact lens wearer in both eyes. H. The subject must have normal eyes.
Exclusion criteria
Exclusion criteria: A. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued). B. Any ocular or systemic allergies or diseases that may interfere with contact lens wear. C. Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. D. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia. E. Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.) F. Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear. G. Any ocular infection. H. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. I. Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment. J. History of binocular vision abnormality or strabismus. K. Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV) by self report). L. Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Comfort assessed using questionnaire 2. Vision assessed using questionnaireTimepoint: Six day lens wear | — |
Secondary
| Measure | Time frame |
|---|---|
| Biomicroscopy findings, Lens fit characteristicsTimepoint: Six day lens wear | — |
Countries
India
Contacts
Public ContactR Sridharan
Johnson and Johnson Limited
Outcome results
None listed