Dispensing Evaluation of a Prototype Contact Lens and a Marketed Contact Lens | NCT01094743 | Trialant
CompletedInterventionalNot ApplicableUpdated Jun 19, 2018
Dispensing Evaluation of a Prototype Contact Lens and a Marketed Contact Lens
ClinicalTrials.gov ID
NCT01094743
Lead Sponsor
Johnson & Johnson Vision Care, Inc.INDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Not Applicable
Enrollment
52Actual
Last Update Posted
Jun 19, 2018Actual
Start Date
Feb 1, 2010Actual
Primary Completion Date
Mar 1, 2010Actual
Completion Date
Mar 1, 2010Actual
Brief Summary
The purpose of this study is to compare visual acuity and redness of eyes between a prototype contact lens and an already marketed contact lens.
Myopia
galyfilcon A prototype lens
lotrafilcon B lens
Ages Eligible for Study
Adult (18-64)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The subject must be at least 18 years of age and no more than 39 years of age.
The subject is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of DW for a minimum of 1 month prior to the study) and willing to wear the study lenses on a daily wear basis (defined as a minimum of 6 hours of wear per day at least five days of the week) for the duration of the study.
The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 9.00D.
Any cylinder power must be ≤ -0.75D.
The subject must have visual acuity best correctable to 20/25+3 or better for each eye.
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 Criteria:
Ocular or systemic allergies or disease which might interfere with contact lens wear.
Systemic disease or use of medication which might interfere with contact lens wear.
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.
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.
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.