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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Keratitis
 Device: Use of B+L Biotrue multipurpose solution (MPS) with PureVision contact lenses
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: 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.

Resource links provided by NLM:

MedlinePlus related topics: Eye Wear
U.S. FDA Resources

Further study details as provided by Epstein, Arthur B., OD, FAAO:

Primary Outcome Measures:
  • 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.


Enrollment: 8
Study Start Date: October 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bausch & Lomb (B+L) Biotrue MPS with B+L PureVision lenses 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01268306

Locations
United States, Arizona
Joel J. Ackerman, OD, PC
Phoenix, Arizona, United States, 85023
Sponsors and Collaborators
Epstein, Arthur B., OD, FAAO
Alcon Laboratories
Investigators
Principal Investigator: Arthur B. Epstein, OD
  More Information

No publications provided

Responsible Party: Arthur Epstein, OD
ClinicalTrials.gov Identifier: NCT01268306     History of Changes
Other Study ID Numbers: CLC-01
Study First Received: December 28, 2010
Last Updated: December 29, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Epstein, Arthur B., OD, FAAO:
contact lens
corneal staining
fluorescein staining
preservatives
 keratitis
punctate keratopathy
superficial punctate keratopathy
SPK

Additional relevant MeSH terms:
Keratitis
Corneal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 19, 2013