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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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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.

Conditions
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Keratitis

Intervention / Treatment
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* Device: B+L Biotrue MPS and B+L PureVision


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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: B+L Biotrue MPS and B+L PureVision<br>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<br>* Subjects use Bausch & Lomb (B+L) Biotrue MPS with B+L PureVision contact lenses<br>* Other names: B+L PureVision;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SPK, contact lens, corneal staining, fluorescein staining, preservatives, keratitis, punctate keratopathy, superficial punctate keratopathy