Clinical trial NCT00762788: Clinical Trial of Several Contact Lenses in Extended Wear
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2008-09-30
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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 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.

Primary outcomes:
measure: Incidence of Corneal Infiltrative Events
timeFrame: 52 weeks
measure: Incidence of Adverse Events
timeFrame: 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chennai
country: India
facility: Vision Research Foundation
state: Tamil Nadu
Study officials:
References: