Status:
COMPLETED
Evaluation of the Performance of Two Contact Lenses Compared to a Marketed Lens
Lead Sponsor:
Johnson & Johnson Vision Care, Inc.
Conditions:
Refractive Ametropia
Eligibility:
FEMALE
18-34 years
Phase:
NA
Brief Summary
This study will serve to evaluate and compare the performance of two new lenses to a marketed lens.
Eligibility Criteria
Inclusion
- Healthy, female adult, at least 18 years of age, and no more than 34 years of age
- The subjects must be female, light eye Caucasian, Non-Hispanic, habitual soft contact lens wearer (both eyes) with light or dark eyes
- Must have rated the Concept Statement positively (i.e., a rating of 4 or 5).
- Optimal vertexed spherical equivalent distance correction must be between -1.00 and -4.00 diopters (D)
- Any cylinder power must be: \<=0.75D
- Visual acuity must be best correctable to 20/25 or better for each eye
- Must have normal eyes (no ocular medications or ocular infection of any type)
- Must read and sign the Statement of Informed Consent
- Must appear able and willing to adhere to the instructions set forth in this clinical protocol.
Exclusion
- Ocular or systemic allergies or disease which might interfere with contact lens wear
- Systemic disease, autoimmune disease, or use of medication which might interfere with contact lens wear
- Clinically significant (grade 3 or worse) corneal edema, corneal neovascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear
- Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear
- Any ocular infection
- Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear
- Any color deficiencies (colorblindness) - to the best of the subject's knowledge
- Pregnancy or lactation
- Diabetes
- Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV)
- Habitual contact lens type is toric, multifocal, or is worn as extended wear.
- Subject presents with one dark iris color and one light iris color.
- Subject has heterochromia iridis (a difference in color between parts of one iris).
- The subject must not be an employee or family member of the clinical study site.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
275 Patients enrolled
Trial Details
Trial ID
NCT01484028
Start Date
November 1 2011
End Date
February 1 2012
Last Update
June 19 2018
Active Locations (15)
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1
Advanced Optometry
Mission Viejo, California, United States, 92691
2
James R Dugue, Optometrist
Mission Viejo, California, United States, 92691
3
Advance Eye Care
Pismo Beach, California, United States, 93448
4
Golden Vision
Sarasota, Florida, United States, 34242