CompletedInterventionalNot ApplicableUpdated May 8, 2017
Multi-Center 2-Week Clinical Evaluation of Three Silicone Hydrogel Contact Lenses | NCT01244516 | Trialant
CompletedInterventionalNot ApplicableUpdated Jun 19, 2018
Multi-Center 2-Week Clinical Evaluation of Three Silicone Hydrogel Contact Lenses
ClinicalTrials.gov ID
NCT01244516
Lead Sponsor
Johnson & Johnson Vision Care, Inc.INDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Not Applicable
Enrollment
540Actual
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 compare the clinical performance of three silicone hydrogel contact lenses over a 2 week period.
Myopia
galyfilcon A, BC 8.30
lotrafilcon B, BC 8.60
comfilcon A, BC 8.60
Ages Eligible for Study
Adult (18-64)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Be no less than 18 and no more than 39 years of age.
Sign Written Informed Consent and investigator to record this on Case Report Form.
Be willing and able to adhere to the instructions set out in the protocol.
Be an existing successful daily wear soft contact lens wearer. For the purposes of this study this means wearing lenses for at least 6 hours per day, 5 days per week for the last month.
No extended wear in the last 3 months.
Subjective refraction must result in a vertex corrected spherical contact lens prescription between -1.00 and -6.00 diopters.
Have refractive astigmatism less than or equal to 1.00 diopters (D) in both eyes.
Achieve visual acuity of 6/9 (20/30) or better in each eye.
Require a visual correction in both eyes (no monovision allowed).
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 amblyopia, no evidence of lid abnormality or infection (including blepharitis/meibomitis), no conjunctival abnormality or infection, no clinically significant slit lamp findings (i.e. stromal edema, vascularization, infiltrates or abnormal opacities), no other active ocular disease.
Exclusion Criteria:
Requires concurrent ocular medication.
Clinically significant corneal stromal haze, corneal vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear.
Clinically significant corneal staining
Requires presbyopic correction (i.e. Not using any presbyopic correction and measured add power of less than +1.00 diopters).
Has had refractive surgery.
Has had eye injury/surgery within 8 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.
Hard, hybrid or Rigid Gas Permeable lens wear in the previous 8 weeks.
Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
Diabetic.
Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease [e.g., Human immunodeficiency virus (HIV)].
History of chronic eye disease (e.g. glaucoma or Age Related Macular Degeneration).
Pregnancy, lactating or planning a pregnancy at the time of enrollment.
Participation in any concurrent clinical trial or in last 30 days