CompletedInterventionalNot ApplicableUpdated May 21, 2015
Daytime Corneal Swelling During Wear of Narafilcon B Lenses | NCT01444287 | Trialant
CompletedInterventionalNot ApplicableUpdated Jun 19, 2018
Daytime Corneal Swelling During Wear of Narafilcon B Lenses
ClinicalTrials.gov ID
NCT01444287
Lead Sponsor
Johnson & Johnson Vision Care, Inc.INDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Not Applicable
Enrollment
22Actual
Last Update Posted
Jun 19, 2018Actual
Start Date
Jan 2010
Primary Completion Date
Feb 2010Actual
Completion Date
Mar 2010Actual
Brief Summary
The purpose of this research is to measure daytime open-eye response to wearing of narafilcon B lenses.
Myopia
narafilcon B
Polymacon
Lotrafilcon A
Spectacles
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Be of legal age (i.e. ≥ 18 years).
Be mentally competent, willing and able to sign a written informed consent form.
Have contact lens distance sphere requirement in the range -1.00D to -6.00D.
Have spectacle astigmatism <1.25D in each eye.
Currently wear soft contact lenses (for at least 6 months prior to the trial) with documentation of current prescription.
Have normal eyes with no evidence of abnormality or disease. For the purpose of this study a normal eye is defined as one having: i) no evidence of lid abnormality or infection; ii) no conjunctival abnormality or infection; iii) no clinically significant slit lamp findings (i.e, edema, staining, scarring, vascularization, infiltrates or abnormal opacities); iv) no other active ocular disease.
Exclusion Criteria:
Required concurrent ocular medication.
Any systemic illness which would contra-indicate lens wear or the medical treatment of which would affect vision or successful lens wear.
Eye injury or surgery within eight weeks immediately prior to enrollment for this study.
Abnormal lacrimal secretions.
Pre-existing ocular irritation that would preclude contact lens fitting.
Keratoconus or other corneal irregularity.
Pregnancy, lactating or planning a pregnancy at the time of enrollment.