Status:
COMPLETED
Clinical Trial of Several Contact Lenses in Extended Wear
Lead Sponsor:
Johnson & Johnson Vision Care, Inc.
Conditions:
Myopia
Eligibility:
All Genders
18-39 years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT00762788
Start Date
February 1 2007
End Date
September 1 2009
Last Update
June 29 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Vision Research Foundation
Chennai, Tamil Nadu, India, 600 006