Study of the Presence and Extent of Corneal Disturbance Associated With B+L Biotrue MPS Used With B+L PureVision Lenses

This study has been completed.
Sponsor:
Collaborator:
Alcon Laboratories
Information provided by:
Epstein, Arthur B., OD, FAAO
ClinicalTrials.gov Identifier:
NCT01268306
First received: December 28, 2010
Last updated: December 29, 2010
Last verified: December 2010

December 28, 2010
December 29, 2010
October 2010
December 2010   (final data collection date for primary outcome measure)
Corneal Staining [ Time Frame: 2-4 hours after contact lens insertion ] [ Designated as safety issue: Yes ]
Disturbance to corneal epithelium visualized by using applied sodium fluorescein solution (as a disclosing agent) evaluated by slit lamp biomicroscopy.
Same as current
Complete list of historical versions of study NCT01268306 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study of the Presence and Extent of Corneal Disturbance Associated With B+L Biotrue MPS Used With B+L PureVision Lenses
A Single-site, Open-Label Prospective Evaluation of Biocompatibility and Corneal Staining Associated With Use of Bausch & Lomb (B+L) BioTrue Contact Lens Multi-purpose Solution (MPS) and B+L PureVision Contact Lenses.

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.

Not Provided
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Keratitis
Device: Use of B+L Biotrue multipurpose solution (MPS) with PureVision contact lenses
Subjects use Bausch & Lomb (B+L) Biotrue MPS with B+L PureVision contact lenses
Other Names:
  • B+L Biotrue
  • B+L PureVision
Experimental: Bausch & Lomb (B+L) Biotrue MPS with B+L PureVision lenses
Intervention: Device: Use of B+L Biotrue multipurpose solution (MPS) with PureVision contact lenses
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
December 2010
December 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01268306
CLC-01
No
Arthur Epstein, OD
Epstein, Arthur B., OD, FAAO
Alcon Laboratories
Principal Investigator: Arthur B. Epstein, OD
Epstein, Arthur B., OD, FAAO
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP