CompletedInterventionalNot ApplicableUpdated May 26, 2016
Non-Dispensing Evaluation of an Investigational Galyfilcon A Soft Contact Lens | NCT01054807 | Trialant
CompletedInterventionalNot ApplicableUpdated Jun 19, 2018
Non-Dispensing Evaluation of an Investigational Galyfilcon A Soft Contact Lens
ClinicalTrials.gov ID
NCT01054807
Lead Sponsor
Johnson & Johnson Vision Care, Inc.INDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Not Applicable
Enrollment
32Actual
Last Update Posted
Jun 19, 2018Actual
Start Date
Nov 1, 2009Actual
Primary Completion Date
Mar 1, 2010Actual
Completion Date
Mar 1, 2010Actual
Brief Summary
The purpose of this investigation is to compare the fit characteristics and vision attributes of an investigational Galyfilcon A contact lens and an approved Galyfilcon A contact lens.
Myopia
Galyfilcon A Habitual Lens
Galyfilcon A 8.7 BC (Investigational)
Galyfilcon A 8.3 BC (Investigational)
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., at least 18 years old)
Sign a written informed consent
Have contact lens distance sphere requirement in the range -1.00D to -6.00D
Have spectacle astigmatism <1.25D in each eye
Currently wear ACUVUE® ADVANCE™ (for at least 6 months) with documentation of current prescription.
Have normal eyes with no evidence of abnormality or 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 enrolment.
Participation in any concurrent clinical trial
Known allergy to silver, silver ions, or silver containing compounds.