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

Epstein, Arthur B., OD, FAAO

Status and phase: Completed; Phase 4

Conditions: Keratitis

Treatments: Device: B+L Biotrue MPS and B+L PureVision

Study type: Interventional

Funder types: Industry

Identifiers

NCT01268306

CLC-01

Details and patient eligibility

About

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.

Full 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

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

B+L Biotrue MPS and B+L PureVision

Experimental group

Description:

Successful contact lens wearers switched to B\&L BioTrue MPS while wearing B+L PureVision lenses

Treatment:

Device: B+L Biotrue MPS and B+L PureVision