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.

Study Overview

• Status: Completed
• Conditions: Keratitis
• Intervention / Treatment: Device: B+L Biotrue MPS and B+L PureVision

Detailed Description

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.

This pilot study is intended to assess the presence of corneal staining among patients who are using BioTrue solution

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85023
      • Joel J. Ackerman, OD, PC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: B+L Biotrue MPS and B+L PureVision; Successful contact lens wearers switched to B&L BioTrue MPS while wearing B+L PureVision lenses	Device: B+L Biotrue MPS and B+L PureVision; Subjects use Bausch & Lomb (B+L) Biotrue MPS with B+L PureVision contact lenses; Other Names: B+L Biotrue; B+L PureVision

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Wiith Corneal Staining	The number of participants who have disturbance of their corneal epithelium visualized by using applied sodium fluorescein solution (as a disclosing agent) evaluated by slit lamp biomicroscopy. Clinically significant staining is described as sufficiently diffuse and deep to pose potential risk of infection by the examiners assessment.	2-4 hours after contact lens insertion

Collaborators and Investigators

• Sponsor: Epstein, Arthur B., OD, FAAO
• Collaborators: Alcon Research
• Investigators: Principal Investigator: Arthur B. Epstein, OD

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: December 28, 2010
• First Submitted That Met QC Criteria: December 29, 2010
• First Posted (Estimate): December 30, 2010

Study Record Updates

• Last Update Posted (Estimate): August 22, 2016
• Last Update Submitted That Met QC Criteria: August 18, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: contact lens; keratitis; corneal staining; fluorescein staining; preservatives; punctate keratopathy; superficial punctate keratopathy; SPK
• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases; Keratitis
• Other Study ID Numbers: CLC-01