Study of the Presence and Extent of Corneal Disturbance Associated With B+L Biotrue MPS Used With B+L PureVision Lenses
Primary Purpose
Keratitis
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
B+L Biotrue MPS and B+L PureVision
Sponsored by
About this trial
This is an interventional supportive care trial for Keratitis focused on measuring contact lens, corneal staining, fluorescein staining, preservatives, keratitis, punctate keratopathy, superficial punctate keratopathy, SPK
Eligibility Criteria
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.
Sites / Locations
- Joel J. Ackerman, OD, PC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
B+L Biotrue MPS and B+L PureVision
Arm Description
Successful contact lens wearers switched to B&L BioTrue MPS while wearing B+L PureVision lenses
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01268306
First Posted
December 28, 2010
Last Updated
August 18, 2016
Sponsor
Epstein, Arthur B., OD, FAAO
Collaborators
Alcon Research
1. Study Identification
Unique Protocol Identification Number
NCT01268306
Brief Title
Study of the Presence and Extent of Corneal Disturbance Associated With B+L Biotrue MPS Used With B+L PureVision Lenses
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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Epstein, Arthur B., OD, FAAO
Collaborators
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratitis
Keywords
contact lens, corneal staining, fluorescein staining, preservatives, keratitis, punctate keratopathy, superficial punctate keratopathy, SPK
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
B+L Biotrue MPS and B+L PureVision
Arm Type
Experimental
Arm Description
Successful contact lens wearers switched to B&L BioTrue MPS while wearing B+L PureVision lenses
Intervention Type
Device
Intervention Name(s)
B+L Biotrue MPS and B+L PureVision
Other Intervention Name(s)
B+L Biotrue, B+L PureVision
Intervention Description
Subjects use Bausch & Lomb (B+L) Biotrue MPS with B+L PureVision contact lenses
Primary Outcome Measure Information:
Title
Number of Participants Wiith Corneal Staining
Description
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.
Time Frame
2-4 hours after contact lens insertion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arthur B. Epstein, OD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Joel J. Ackerman, OD, PC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of the Presence and Extent of Corneal Disturbance Associated With B+L Biotrue MPS Used With B+L PureVision Lenses
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