NCT00762788CompletedNot Applicable
Clinical Trial of Several Contact Lenses in Extended Wear
Johnson & Johnson Vision Care, Inc.1 site in 1 country350 target enrollmentStarted: February 1, 2007Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 350
- Locations
- 1
- Primary Endpoint
- Incidence of Corneal Infiltrative Events
Study Overview
Brief Summary
The study is to clinically evaluate currently marketed contact lenses when used in an extended wear modality of up to seven days/six nights.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to 39 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Be of legal age, and be between 18 and 39 years of age.
- •Signed Written Informed Consent and Investigator to record this on Case Report Form (CRF) in appropriate space.
- •Require a visual correction in both eyes (Monovision not allowed)
- •Require a soft contact lens spherical correction between -0.50 and -9.00D.
- •Have an astigmatic correction less than 1.50D in both eyes.
- •Be able to wear the lens powers available for this study.
- •Be able to regularly wear the lenses on a 7 day/6 night extended wear basis (e.g. does not regularly swim more than once a week)
- •Be correctable to a visual acuity of 20/30 or better in each eye.
- •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.
- •No clinically significant slit lamp findings
- •No other active ocular disease.
- •No previous ocular surgery.
Exclusion Criteria
- •Requires concurrent ocular medication.
- •Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
- •No Clinically significant (Grade 3 or 4) slit lamp findings including corneal edema, corneal vascularization, corneal staining, tarsal abnormalities, bulbar injection, or any other abnormality of the cornea that would contraindicate contact lens wear.
- •Diabetic.
- •Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
- •PMMA or RGP lens wear in the previous 8 weeks.
- •Has had refractive surgery. Has had eye injury/surgery within 8 weeks immediately prior to enrolment 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 only.
- •Participation in any concurrent clinical trial.
- •Currently wearing B&L PureVision, Ciba O2 Optix, Ciba Night & Day, CooperVision Biofinity, Vistakon ACUVUE® OASYS, or Vistakon ACUVUE®2 on an EW basis
- •Has had previous adverse event(s) contraindicating EW e.g. MK or greater than 2 corneal scars which appear to be contact lens related (e.g. not trauma related).
- •Has had an eye injury or surgery within the last eight weeks.
Arms & Interventions
senofilcon A contact lens
Active Comparator
ACUVUE OASYS
Intervention: senofilcon A (Device)
lotrafilcon A contact lens
Active Comparator
NIGHT&DAY
Intervention: lotrafilcon A (Device)
lotrafilcon B contact lens
Active Comparator
O2Optix
Intervention: lotrafilcon B (Device)
balafilcon A contact lens
Active Comparator
PureVision
Intervention: balafilcon A (Device)
comfilcon A contact lens
Active Comparator
Biofinity
Intervention: comfilcon A (Device)
etafilcon A contact lens
Active Comparator
ACUVUE 2
Intervention: etafilcon A (Device)
Outcomes
Primary Outcomes
Incidence of Corneal Infiltrative Events
Time Frame: 52 weeks
Extended wear is defined as 7 days, 6 nights of lens wear, weekly replacement of lenses. Incidence was calculated as the number of subjects with event divided by the total number of subjects assigned to that lens type.
Incidence of Adverse Events
Time Frame: 52 weeks
Occurrence of any Adverse Event by study lens. Incidence was calculated as the number of subjects with event divided by the total number of subjects assigned to that lens type.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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