N/A
N=314
Clinical Trial of Several Contact Lenses in Extended Wear
Myopia
Bottom Line
View on ClinicalTrials.gov: NCT00762788 ↗Enrolled (actual)
314
Serious AEs
0.6%
Results posted
May 2015
Primary outcome: Primary: Incidence of Corneal Infiltrative Events — 31; 16; 10; 8 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- senofilcon A (Device); lotrafilcon A (Device); lotrafilcon B (Device); balafilcon A (Device); comfilcon A (Device); etafilcon A (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Vision Care, Inc.
- Primary completion
- Sep 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Corneal Infiltrative Events |
31; 16; 10; 8; 33; 10 | — |
| PRIMARY Incidence of Adverse Events |
35; 24; 19; 31; 37; 12 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00762788). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.