Keratitis
Conditions
Keywords
contact lens, corneal staining, fluorescein staining, preservatives, keratitis, punctate keratopathy, superficial punctate keratopathy, SPK
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
Interventions
DEVICEB+L Biotrue MPS and B+L PureVision
Subjects use Bausch & Lomb (B+L) Biotrue MPS with B+L PureVision contact lenses
Sponsors
Alcon Research
Epstein, Arthur B., OD, FAAO
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
Subjects randomly recruited from contact lens wearing population in an optometric practice
Pre-assignment details
Patients with spherical contact lens corrections who achieved acceptable acuity with test lenses were offered study participation.
Participants by arm
| Arm | Count |
|---|---|
| Bausch & Lomb (B+L) Biotrue MPS With B+L PureVision Lenses 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 | 8 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Bausch & Lomb (B+L) Biotrue MPS With B+L PureVision Lenses |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Region of Enrollment United States | 8 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
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.
Time frame: 2-4 hours after contact lens insertion
Population: Subjects who returned for examination post-challenge in the allotted time and who had observable corneal staining on slit lamp examination
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bausch & Lomb (B+L) Biotrue MPS With B+L PureVision Lenses | Number of Participants Wiith Corneal Staining | Clinically signficant staining | 1 participants |
| Bausch & Lomb (B+L) Biotrue MPS With B+L PureVision Lenses | Number of Participants Wiith Corneal Staining | Clinically insigificant staining | 6 participants |