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

NCT01268306 | Completed Phase 4 Results

• 1 other identifier: CLC-01
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Keratitis

Keywords

contact lens; corneal staining; fluorescein staining; preservatives; keratitis; punctate keratopathy; superficial punctate keratopathy; SPK

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

B+L Biotrue MPS and B+L PureVision

EXPERIMENTAL

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

Interventions

B+L Biotrue MPS and B+L PureVision DEVICE

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

Also known as: B+L Biotrue, B+L PureVision

B+L Biotrue MPS and B+L PureVision

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Epstein, Arthur B., OD, FAAO: lead
• Alcon Research: collaborator

Study Sites (1)

Joel J. Ackerman, OD, PC

Phoenix, Arizona, 85023, United States

Location

MeSH Terms

Conditions

Keratitis

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Limitations and Caveats

Pilot study with insignificant subject population for statistical analysis

Results Point of Contact

• Title: Dr. Arthur Epstein
• Organization: Arthur B. Epstein, OD

artepstein@yahoo.com

424-226-2020

Study Officials

• Arthur B. Epstein, OD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2010
• First Posted: December 30, 2010
• Study Start: October 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: August 22, 2016
• Results First Posted: August 22, 2016

Record last verified: 2016-08

Locations

US (1)