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

Keratitis Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01268306
• Other study ID #: CLC-01
• Status: Completed
• Phase: Phase 4
• First received: December 28, 2010
• Last updated: August 18, 2016
• Start date: October 2010
• Est. completion date: December 2010

Study information

• Verified date: August 2016
• Source: Epstein, Arthur B., OD, FAAO
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Keratitis

Intervention

Device:
• B+L Biotrue MPS and B+L PureVision
Subjects use Bausch & Lomb (B+L) Biotrue MPS with B+L PureVision contact lenses

Locations

Country	Name	City	State
United States	Joel J. Ackerman, OD, PC	Phoenix	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Epstein, Arthur B., OD, FAAO	Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes