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

• Sponsor: Epstein, Arthur B., OD, FAAO (Other)
• Overall Status: Completed
• CT.gov ID: NCT01268306
• Collaborator: Alcon Research (Industry)
• Enrollment: 8
• Location: 1
• Arm: 1
• Duration (Months): 2
• Patients Per Site Per Month: 4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Keratitis	Device: B+L Biotrue MPS and B+L PureVision	Phase 4

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• 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 Start Date: Oct 1, 2010
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: B+L Biotrue MPS and B+L PureVision 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; Subjects use Bausch & Lomb (B+L) Biotrue MPS with B+L PureVision contact lenses; Other Names: B+L Biotrue B+L PureVision

Outcome Measures

Primary Outcome Measures

1. Number of Participants Wiith Corneal Staining [2-4 hours after contact lens insertion]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Joel J. Ackerman, OD, PC	Phoenix	Arizona	United States	85023

Sponsors and Collaborators

• Epstein, Arthur B., OD, FAAO
• Alcon Research

Investigators

• Principal Investigator: Arthur B. Epstein, OD,

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Epstein, Arthur B., OD, FAAO
• ClinicalTrials.gov Identifier: NCT01268306
• Other Study ID Numbers: CLC-01
• First Posted: Dec 30, 2010
• Last Update Posted: Aug 22, 2016
• Last Verified: Aug 1, 2016

• Keywords provided by Epstein, Arthur B., OD, FAAO: contact lens; corneal staining; fluorescein staining; preservatives; keratitis; punctate keratopathy; superficial punctate keratopathy; SPK
• Additional relevant MeSH terms: Keratitis

Study Results

Participant Flow

Recruitment Details	Subjects randomly recruited from contact lens wearing population in an optometric practice
Pre-assignment Detail	Patients with spherical contact lens corrections who achieved acceptable acuity with test lenses were offered study participation.

Arm/Group Title	Bausch & Lomb (B+L) Biotrue MPS With B+L PureVision Lenses
Arm/Group Description	Use of B+L Biotrue multipurpose solution (MPS) with PureVision contact lenses : Subjects use Bausch & Lomb (B+L) Biotrue MPS with B+L PureVision contact lenses
Period Title: Overall Study
STARTED	8
COMPLETED	7
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Bausch & Lomb (B+L) Biotrue MPS With B+L PureVision Lenses
Arm/Group Description	Use of B+L Biotrue multipurpose solution (MPS) with PureVision contact lenses : Subjects use Bausch & Lomb (B+L) Biotrue MPS with B+L PureVision contact lenses
Overall Participants	8
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	8 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	5 62.5%
Male	3 37.5%
Region of Enrollment (participants) [Number]
United States	8 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Subjects who returned for examination post-challenge in the allotted time and who had observable corneal staining on slit lamp examination

Arm/Group Title	Bausch & Lomb (B+L) Biotrue MPS With B+L PureVision Lenses
Arm/Group Description	Use of B+L Biotrue multipurpose solution (MPS) with PureVision contact lenses : Subjects use Bausch & Lomb (B+L) Biotrue MPS with B+L PureVision contact lenses
Measure Participants	7
Clinically signficant staining	1 12.5%
Clinically insigificant staining	6 75%

Adverse Events

Time Frame	6 weeks
Arm/Group Title	Bausch & Lomb (B+L) Biotrue MPS With B+L PureVision Lenses
Arm/Group Description	Use of B+L Biotrue multipurpose solution (MPS) with PureVision contact lenses : Subjects use Bausch & Lomb (B+L) Biotrue MPS with B+L PureVision contact lenses
All Cause Mortality
	Bausch & Lomb (B+L) Biotrue MPS With B+L PureVision Lenses
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Bausch & Lomb (B+L) Biotrue MPS With B+L PureVision Lenses
	Affected / at Risk (%)	# Events
Total	0/8 (0%)
Other (Not Including Serious) Adverse Events
	Bausch & Lomb (B+L) Biotrue MPS With B+L PureVision Lenses
	Affected / at Risk (%)	# Events
Total	0/8 (0%)

Limitations/Caveats

Pilot study with insignificant subject population for statistical analysis

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.