A clinical trial to evaluate investigational Silicone Hydrogel Contact Lenses worn continuously for one week
- Conditions
- Health Condition 1: null- Vision Correction â??Myopia
- Registration Number
- CTRI/2015/04/005701
- 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
- 280
A. The subject must read and 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 at least 18 and no more than 39 years of age.
D. The subjectâ??s spherical equivalent distance refraction must be in the range of -1.00 to - 5.50 diopters in each eye.
E. The subjectâ??s refractive cylinder must be less than 1.00 diopters in each eye.
F. The subject must have best corrected visual acuity of 20/30 or better in each eye.
G. The subject must be without history of contact lens use in the past 12 months.
H. The subject must have normal eyes (i.e., no ocular medications or infections of any type).
A. Any previous experience wearing contact lenses on an overnight or extended wear basis (at least 1 night per month)
B. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
C. Currently a regular smoker (1 or more times per month).
D. Current routine swimmer (1 or more times per month).
E. Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
F. Any systemic disease (ex. Sjögrenâ??s Syndrome), autoimmune disease (ex. rheumatoid arthritis), or use of medication (ex. chronic steroid use), which may interfere with contact lens wear.
G. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion by keratometry.
H. Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy,PRK, LASIK, etc.).
I. 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 cornealinflammatory event (e.g., past peripheral ulcer or round peripheral scar), or anyother ocular abnormality that may contraindicate contact lens wear.
J. Any ocular infection.
K. Any corneal distortion resulting from previous hard or rigid gas permeable contactlens wear.
L. Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.
M. History of binocular vision abnormality or strabismus.
N. Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV) by self report).
O. Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The number of first occurred serious and significant corneal infiltrative adverse events deemed to be related to contact lens wear during the 6-month extended wear study periodTimepoint: 6night/7day replacement modality
- Secondary Outcome Measures
Name Time Method Comfort and overall quality of vision scores using Contact Lens User Experience questionnaire.Timepoint: 6night 7day replacement modality