Comparison of Lens Fit and Lens Power of a New Contact Lens to Two Marketed Contact Lenses in a Population of Soft Contact Lens Wearers | NCT01244529 | Trialant
CompletedInterventionalNot ApplicableUpdated Jun 19, 2018
Comparison of Lens Fit and Lens Power of a New Contact Lens to Two Marketed Contact Lenses in a Population of Soft Contact Lens Wearers
ClinicalTrials.gov ID
NCT01244529
Lead Sponsor
Johnson & Johnson Vision Care, Inc.INDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Not Applicable
Enrollment
41Actual
Last Update Posted
Jun 19, 2018Actual
Start Date
Sep 1, 2010Actual
Primary Completion Date
Nov 1, 2010Actual
Completion Date
Nov 1, 2010Actual
Brief Summary
The purpose of this study is to evaluate the comparability of lens fit and lens power of a new contact lens to the lens fit and lens power of two marketed lenses.
Myopia
galy A Plus
seno A
galy A
Ages Eligible for Study
Adult (18-64)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Must be at least 18 years of age and no more than 55 years of age.
Must sign written informed consent.
Optimal spherical equivalent distance correction must be between -1.00 and -6.00 diopters.
Have spectacle astigmatism ≤ -0.75 diopter cylinder in both eyes.
Must have visual acuity best correctable to 20/25+3 or better for each eye.
Must appear able and willing to adhere to the instructions set forth in this clinical protocol.
Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having: No evidence of lid abnormality or infection; No conjunctival abnormality or infection; No clinical significant slit lamp findings, (i.e., oedema, staining, scarring, vascularization, infiltrates or abnormal opacities); No other active ocular disease.
The subject is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of daily wear 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.
Exclusion Criteria:
Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
Any previous eye surgery involving the anterior segment.
Pre-existing ocular disease that would preclude contact lens fitting.
Abnormal lacrimal secretions.
Keratoconus or other corneal irregularity.
Pregnancy, lactating or planning a pregnancy at the time of enrollment.
Participation in any concurrent clinical trial.
Subject's habitual contact lens type is toric or multifocal.