Status:
COMPLETED
Dispensing Evaluation of Subjective Comfort, Vision, and Handling of a New Lens Compared to a Marketed Lens
Lead Sponsor:
Johnson & Johnson Vision Care, Inc.
Conditions:
Refractive Ametropia
Eligibility:
FEMALE
18-34 years
Phase:
NA
Brief Summary
To evaluate and compare the performance of a new contact lens to a marketed contact lens.
Eligibility Criteria
Inclusion
- The subject must be a healthy adult at least 18 years of age and no more than 34 years of age.
- The subjects must be female, dark eye Caucasian, Non-Hispanic habitual soft contact lens wearer (both eyes).
- The subject rated the Concept Statement positively (i.e., a rating of 4 or 5). If not the subject is not eligible to participate.
- The subject must have no known ocular or systemic allergies that might interfere with contact lens wear.
- The subject must have no known systemic disease, or need for medication, which might interfere with contact lens wear.
- The subject's optimal vertexed spherical equivalent distance correction must be between-1.00 and -4.00D.
- Any cylinder power must be:\<=0.75D.
- The subject must have visual acuity best correctable to 20/25 or better for each eye.
- The subject must have normal eyes (no ocular medications or ocular infection of any type).
- The subject must read and sign the Statement of Informed Consent.
- The subject 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 (color blindness) - 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 is 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 :
103 Patients enrolled
Trial Details
Trial ID
NCT01484054
Start Date
November 1 2011
End Date
February 1 2012
Last Update
June 19 2018
Active Locations (6)
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1
Bloomfield, Connecticut, United States, 06002
2
Tallahassee, Florida, United States, 32308
3
Overland Park, Kansas, United States, 66207
4
Jamestown, New York, United States, 14750