Upper lid margin staining with different soft contact lenses and lens

Upper lid margin staining with different soft contact lenses and lens care solution combinations
MM
1Centre
1
Schulze ,
S
1
Srinivasan ,
S
2
Hickson-Curran ,
DA
3
Berntsen ,
G
4
Howarth ,
JJ
3
Nichols ,
PB
4
Morgan ,
LW
1
Jones
for Contact Lens Research, School of Optometry and Vision Science, University of Waterloo, Canada, 2Johnson & Johnson Vision Care, Inc., Jacksonville, FL, USA
3The Ocular Surface Institute, College of Optometry, University of Houston, Houston, TX, USA, 4Eurolens Research, University of Manchester, UK
Introduction
During blinking the marginal conjunctiva of the upper eyelid is in close apposition
to the ocular surface, or contact lens (CL). This results in “brushing” of the
eyelid’s conjunctival surface (like the windscreen wiper of a car)1 and may result
in upper lid margin staining (ULMS)/Lid Wiper Epitheliopathy (LWE).
ULMS is a clinical sign of ocular irritation that is believed to be caused by
increased friction and shear forces between the palpebral lid margin region and
the ocular surface.
It may also result from decreased lubrication, caused by alterations in the tearfilm and its mucous component and the apposing bulbar conjunctiva and cornea
and/or CL surface in lens wearers and may be detected by vital dye staining of
the upper and lower lid margin surfaces.2-4
Korb and colleagues reported greater prevalence of LWE/ULMS in contact lens
wearers who report ocular discomfort.5
To-date, there are no reports in the literature that compare ULMS with different
contact lens care systems and lens types combinations.
Purpose
Methods (continued)
Results (continued)
Table 1: 0-3 grading scheme proposed by Korb et al2
Length
Grade
Width
Grade
<2mm
0
<25%
0
2-4mm
1
25-50%
1
5-9mm
2
50-75%
2
>10mm
3
75 or > %
3
CR5230 - Comparisonsof
of Lid
Wiper Epitheliopathy
between Solutions
Comparison
ULMS
grades(LWE)
for Grades
solutions
with
Lens Type: Acuvue 2
Etafilcon A
Favors Tests
Favors Clear Care
Favors test
solution
ULMS was analyzed using a linear mixed model to test for the difference between the test
solutions (MPS) and the control solution (H2O2) within each lens type. Statistical analysis
was controlled for baseline ULMS and factors including age, solution order, lens type etc.
Habitual SCL wearers (n=237) were enrolled at three different sites and
randomised to wear one of three two-weekly replacement SCL types (etafilcon A
(ACUVUE® 2®), galyfilcon A (ACUVUE® ADVANCE® Plus), or senofilcon A
(ACUVUE® OASYS®) on a daily wear basis for 10-14 days.
Polyaminopropyl
Biotrue
biguanide
+
polyquaternium
Non-inferiority of a test solution relative to the control was concluded if the upper limit was
below 0.5. The superiority was established if the upper limit was below 0. The clinical
superiority was claimed if the upper limit was below -0.5.
POLYQUAD
+
O-F PureMois
ALDOX
Polyaminopropyl
Biotrue
biguanide
+
polyquaternium
Results
Each participant was assigned to use three multipurpose solutions (MPS; test)
and one hydrogen peroxide solution (control) in a randomly-assigned order, and
received a new pair of lenses with each new solution:
Polyaminopropyl
Biotrue
biguanide
+
polyquaternium
0.5
Biotrue® : polyaminopropyl biguanide + polyquaternium-1
RevitaLens OcuTec® : alexidine + polyquaternium-1
AOSept® Plus : hydrogen peroxide (H2O2)
There was a washout period of at least four days (wearing 1-DAY ACUVUE®
MOIST® daily disposable lenses) between solutions.
The eyes were stained with sodium fluorescein (NaFl) and lissamine green (LG)
dyes using an optimized technique to determine the ULMS grade (Figure 1).
Horizontal length and sagittal width of ULMS were graded on a 0-3 scale
following the grading scheme proposed by Korb et al.2 For each dye, horizontal
and sagittal grades were averaged in order to derive a final ULMS grade (Table
1).
1.0
Polyaminopropyl
Biotrue
biguanide
+
polyquaternium
1.5
2.0
2.5
0.5
LS-Means of ULMS
at
2
week
follow
up:
Lens Type: Acuvue Oasys
Senofilcon A
Alexidine +
RevitaLens
polyquaternium
Alexidine +
RevitaLens
polyquaternium
0.5
1.0
2.0
2.5
3.0
LS-Means with 95% Confidence Interval
Favors H2O2
Favors test
solution
Favors H2O2
Alexidine +
RevitaLens
polyquaternium
-0.1
-0.0
0.1
-0.0
POLYQUAD
+
O-F PureMois
ALDOX
Polyaminopropyl
biguanide
+
Biotrue
polyquaternium
0.0
-0.1
-1.0 -0.9 -0.8 -0.7 -0.6 -0.5 -0.4 -0.3 -0.2 -0.1 0.0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0
-1.0 -0.9 -0.8 -0.7 -0.6 -0.5 -0.4 -0.3 -0.2 -0.1 0.0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0
LS-Mean Difference with Adjusted 95% Confidence Interval
LS-Mean Difference with Adjusted 95% Confidence Interval
References
1.
2.
3.
4.
Bramwell E. The upward movement of the eyes. Brain 1928:51(1-17).
Korb DR, et al., Lid-wiper epitheliopathy and dry-eye symptoms in contact lens wearers. CLAO J 2002;28:211-6.
Korb DR, et al. Lid wiper epitheliopathy and dry eye symptoms. Eye Contact Lens 2005;31:2-8.
Berry M, et al., Mucins and ocular signs in symptomatic and asymptomatic contact lens wear. Optom Vis Sci
2008;85:E930-8.
5. Korb DR., et al., Prevalence of lid wiper epitheliopathy in subjects with dry eye signs and symptoms. Cornea 2010;29:37783.
0.95
0.0
0.5
1.0
1.5
2.0
2.5
3.0
Email: [email protected]
LS-Means with 95% Confidence Interval
Figure 2: Least square (LS) Means of ULMS at the 2-week follow-up visit for the three MPS test solutions and the hydrogen peroxide control
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CR5230 - Comparisons
Lid Wiper Epitheliopathy
(LWE)
Grades between with
Solutionsall
Comparison
ofofULMS
grades
for
solutions
Lens Type: Overall
lens types
Favors Tests
Favors Clear Care
For the CLs and solutions evaluated in this study, the levels of ULMS do not
appear to be dependent on the combination of CL and solution used.
1.01
Polyaminopropyl
Biotrue
biguanide
+
polyquaternium
1.5
LS-Mean Difference with Adjusted 95% Confidence Interval
Although statistically significant, this difference in final ULMS grade between
polyaminopropyl biguanide + polyquaternium solution and hydrogen peroxide
solution while wearing galyfilcon A does not appear to be clinically meaningful.
3.0
0.99
Hydrogen
Clear
Peroxide
(H2OCare
2)
1.04
0.0
2.5
1.06
POLYQUAD
+
O-F PureMoist
ALDOX
1.01
Polyaminopropyl
Biotrue
biguanide
+
polyquaternium
2.0
LS-Means of ULMS at
2
week
follow
up:
Lens Type: Overall
Overall
1.00
Hydrogen
Clear
Peroxide
(H2OCare
2)
1.5
CR5230 - LS-Means of Lid Wiper Epitheliopathy (LWE) Grade at 2-week Follow-up
0.95
POLYQUAD
+
O-F PureMoist
ALDOX
1.0
LS-Means with 95% Confidence Interval
LS-Means with 95% Confidence Interval
CR5230 - LS-Means of Lid Wiper Epitheliopathy (LWE) Grade at 2-week Follow-up
LS-Mean Difference with Adjusted 95% Confidence Interval
There was no difference in ULMS between the three test MPS and the H2O2
control solution for any of the three contact lenses, except when wearing
galyfilcon A in combination with polyaminopropyl biguanide + polyquaternium
solution (Figure 3).
0.88
0.0
3.0
-1.0 -0.9 -0.8 -0.7 -0.6 -0.5 -0.4 -0.3 -0.2 -0.1 0.0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0
The final ULMS grades for all solutions tested were very similar, and showed
levels typically found in SCL wearers.
1.11
Hydrogen
Clear Care
Peroxide (H2O2)
0.93
-1.0 -0.9 -0.8 -0.7 -0.6 -0.5 -0.4 -0.3 -0.2 -0.1 0.0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0
Conclusions
1.07
POLYQUAD
+
O-F PureMoist
ALDOX
0.90
Hydrogen
Clear
Care
Peroxide
(H2O
2)
p<0.0092
1.20
Alexidine +
RevitaLens
polyquaternium
0.89
-0.2
Figure 3: LS-Mean Difference of ULMS at the 2-week follow-up visit, between the three MPS test solutions and the H2O2 control
CR5230 - LS-Means of Lid Wiper Epitheliopathy (LWE) Grade at 2-week Follow-up
1.03
0.0
OPTI-FREE® PureMoist® : POLYQUAD® + ALDOX®
LS-Means of ULMS
at 2 week follow up:
Lens Type: Acuvue Advance
Galyfilcon A
LS-Means of ULMS Lens
at Type:
2 week
follow up:
Acuvue 2
Etafilcon A
CR5230 - LS-Means of Lid Wiper Epitheliopathy (LWE) Grade at 2-week Follow-up
Polyaminopropyl
Biotrue
biguanide
+
polyquaternium
0.0
Favors test
solution
Alexidine
+
RevitaLens
polyquaternium
-0.0
O-F PureMois
POLYQUAD
+
ALDOX
CR5230 - Comparisonsof
of Lid
Wiper Epitheliopathy
(LWE)
Grades
between Solutions
Comparison
ULMS
grades
for
solutions
with
Lens Type: Acuvue Oasys
Senofilcon A
Favors Tests
Favors Clear Care
Comparisons between each test solution and the control solution within each lens type were
carried out using simultaneous two-sided 95% confidence intervals constructed for leastsquare mean differences (test minus control).
POLYQUAD
+
O-F PureMoist
ALDOX
0.1
Alexidine
+
RevitaLens
polyquaternium
-0.0
O-F PureMois
POLYQUAD
+
ALDOX
Data for all randomised subjects who successfully tried at least one study solution (intent-totreat population) were included in the analysis.
Alexidine +
RevitaLens
polyquaternium
0.1
Favors H2O2
Figure 1: Examples of ULMS/LWE with sodium fluorescein (left panel) and Lissamine Green dye
(right panel)
Complete data for all four solutions were available from 206 participants (87%).
The study was a multi-site, bilateral, randomised clinical trial.
Favors test
solution
Favors H2O2
Alexidine
+
RevitaLens
polyquaternium
To assess the upper lid margin staining (ULMS) when using three different soft
contact lenses (SCL) with four different care solution combinations.
Materials and Methods
CR5230 - Comparisonsof
of Lid
Wiper Epitheliopathy
(LWE)
Grades
between Solutions
Comparison
ULMS
grades
for
solutions
with
Lens Type: Acuvue Advance
Galyfilcon A
Favors Tests
Favors Clear Care
QR code links
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Funding for this study was provided by Johnson & Johnson Vision Care, Inc.
ACUVUE®2®, ACUVUE® OASYS® and ACUVUE® ADVANCE® PLUS are registered trademarks of Johnson & Johnson Vision Care, Inc. All other
companies brands mentioned herein are the trademarks of their respective owners.

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