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

NCT ID: NCT01268306

Last Updated: 2016-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2010-12-31

Brief Summary

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

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

Conditions

Keratitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

B+L Biotrue MPS and B+L PureVision

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

Group Type: EXPERIMENTAL

B+L Biotrue MPS and B+L PureVision

Intervention Type: DEVICE

Subjects use Bausch \& Lomb (B+L) Biotrue MPS with B+L PureVision contact lenses

Interventions

B+L Biotrue MPS and B+L PureVision

Subjects use Bausch \& Lomb (B+L) Biotrue MPS with B+L PureVision contact lenses

Intervention Type: DEVICE

Other Intervention Names

B+L Biotrue; B+L PureVision

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: collaborator

Epstein, Arthur B., OD, FAAO

INDIV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arthur B. Epstein, OD

Role: PRINCIPAL_INVESTIGATOR

Locations

Joel J. Ackerman, OD, PC

Phoenix, Arizona, United States

Countries

United States

Other Identifiers

CLC-01

Identifier Type: -

Identifier Source: org_study_id