Study of the Presence and Extent of Corneal Disturbance Associated With B+L Biotrue MPS Used With B+L PureVision Lenses
Condition: Keratitis
MeSH terms: Keratitis
Intervention: B+L Biotrue MPS and B+L PureVision
Intervention description: Subjects use Bausch & Lomb (B+L) Biotrue MPS with B+L PureVision contact lenses
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: contact lens; corneal staining; fluorescein staining; preservatives; keratitis; punctate keratopathy; superficial punctate keratopathy; SPK

Summary:

      Corneal epithelial disruption, commonly termed "corneal staining" has been frequently
      associated with contact lens wear. Previous research has demonstrated higher levels of
      observed corneal staining when certain combinations of contact lenses and lens care products
      are used, particularly under daily wear regimens. B+L lenses made from Balafilcon
      (PureVision) have been associated with the highest rates of observed staining. Additionally,
      polyhexamethylene biguanide (PHMB) based lens care products, specifically B+L ReNu MultiPlus
      have been implicated in higher rates of staining. In general, many lenses constructed from
      newer, silicone hydrogel (SiHy) materials appear more susceptible to increased rates and
      amounts of corneal staining.

      Although the clinical significance of staining is debated, most clinicians agree that less
      staining is preferable to greater amounts of staining. Advances in understanding as well as
      the specifics of lens care product formulation ideally will have resulted in design of newer
      products that minimize corneal staining and maximize product performance. This study will
      examine rates of corneal staining using B+L's recently introduced lens care product: BioTrue
      with the B+L PureVision lens which has previously been associated with the highest levels of
      staining.
    

Eligibility criteria:

        Inclusion Criteria:

          1. The informed consent document must be read, signed and dated by the patient or legally
             authorized representative.

          2. Subjects 18 years of age or older.

          3. Subjects may be of either sex and of any race.

          4. History (within the past 6 months) of successful soft contact lens wear.

          5. Subjects must be free of any ocular disorder that would contraindicate contact lens
             wear

          6. Subjects must have grade 1 (trace) or less corneal staining at baseline measurement as
             determined by the investigator or subinvestigator

          7. Ocular health within normal limits as determined by the investigator or
             subinvestigator.

          8. Willing to wear test contact lenses and use test lens care product throughout the
             length of the study period.

        Exclusion Criteria:

          1. Inability to be properly fitted with test lenses.

          2. Inability to comfortably tolerate test lenses or lens care product.

          3. Inability or unwillingness to follow all study instructions and complete study visits
             as required.

          4. Greater than grade 1 (trace) staining in any quadrant at baseline examination.

          5. Presumed or actual ocular infection (bacterial, viral, or fungal) or history of ocular
             herpes in either eye as determined by subject history and/or examination.