Clinical Trial of Several Contact Lenses in Extended Wear

Johnson & Johnson (J&J)

Status: Completed

Conditions: Myopia

Treatments: Device: balafilcon A; Device: etafilcon A; Device: comfilcon A; Device: lotrafilcon B; Device: senofilcon A; Device: lotrafilcon A

Study type: Interventional

Funder types: Industry

Identifiers

NCT00762788

CR-4472

Details and patient eligibility

About

The study is to clinically evaluate currently marketed contact lenses when used in an extended wear modality of up to seven days/six nights.

Enrollment: 350 patients

Sex: All

Ages: 18 to 39 years old

Volunteers: No Healthy Volunteers

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.

Trial design

350 participants in 6 patient groups

senofilcon A contact lens

Active Comparator group

Description:

ACUVUE OASYS

Treatment:

Device: senofilcon A

lotrafilcon A contact lens

Active Comparator group

Description:

NIGHT\&DAY

Treatment:

Device: lotrafilcon A

lotrafilcon B contact lens

Active Comparator group

Description:

O2Optix

Treatment:

Device: lotrafilcon B

balafilcon A contact lens

Active Comparator group

Description:

PureVision

Treatment:

Device: balafilcon A

comfilcon A contact lens

Active Comparator group

Description:

Biofinity

Treatment:

Device: comfilcon A

etafilcon A contact lens

Active Comparator group

Description:

ACUVUE 2

Treatment:

Device: etafilcon A