Clinical Trial of Several Contact Lenses in Extended Wear

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 Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: senofilcon A; Device: lotrafilcon A; Device: lotrafilcon B; Device: balafilcon A; Device: comfilcon A; Device: etafilcon A

• Study Type: Interventional
• Enrollment (Actual): 350
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Tamil Nadu
    • Chennai, Tamil Nadu, India, 600 006
      • Vision Research Foundation

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Corneal Infiltrative Events	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.	52 weeks
Incidence of Adverse Events	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.	52 weeks

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.

Study record dates

Study Major Dates

• Study Start: February 1, 2007
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: September 26, 2008
• First Submitted That Met QC Criteria: September 26, 2008
• First Posted (Estimate): September 30, 2008

Study Record Updates

• Last Update Posted (Estimate): June 29, 2015
• Last Update Submitted That Met QC Criteria: June 1, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: CR-4472