Clinical Trial of Several Contact Lenses in Extended Wear

• ClinicalTrials.gov Identifier: NCT00762788
• Recruitment Status: Completed
• First Posted: September 30, 2008
• Results First Posted: May 15, 2015
• Last Update Posted: June 29, 2015
• Sponsor: Johnson & Johnson Vision Care, Inc.
• Information provided by (Responsible Party): Johnson & Johnson Vision Care, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Myopia	Device: senofilcon A; Device: lotrafilcon A; Device: lotrafilcon B; Device: balafilcon A; Device: comfilcon A; Device: etafilcon A	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 350 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Study Start Date: February 2007
• Actual Primary Completion Date: September 2009
• Actual Study Completion Date: September 2009

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: senofilcon A contact lens; ACUVUE OASYS	Device: senofilcon A; 1 week extended wear contact lens
Active Comparator: lotrafilcon A contact lens; NIGHT&DAY	Device: lotrafilcon A; 1 week extended wear contact lens
Active Comparator: lotrafilcon B contact lens; O2Optix	Device: lotrafilcon B; 1 week extended wear contact lens
Active Comparator: balafilcon A contact lens; PureVision	Device: balafilcon A; 1 week extended wear contact lens
Active Comparator: comfilcon A contact lens; Biofinity	Device: comfilcon A; 1 week extended wear contact lens
Active Comparator: etafilcon A contact lens; ACUVUE 2	Device: etafilcon A; 1 week extended wear contact lens

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 39 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

India

Vision Research Foundation

Chennai, Tamil Nadu, India, 600 006

Sponsors and Collaborators

Johnson & Johnson Vision Care, Inc.

More Information

• Responsible Party: Johnson & Johnson Vision Care, Inc.
• ClinicalTrials.gov Identifier: NCT00762788
• Other Study ID Numbers: CR-4472
• First Posted: September 30, 2008
• Results First Posted: May 15, 2015
• Last Update Posted: June 29, 2015
• Last Verified: June 2015

Additional relevant MeSH terms:

Myopia; Refractive Errors; Eye Diseases