The document presents a staining grid that summarizes ocular responses and corneal staining levels associated with different contact lens and multipurpose solution combinations. The grid uses color coding to indicate minimal, marginal, and excessive staining levels based on staining area percentages. It provides staining results from multiple studies involving over 3,000 patient visits testing various lens materials and solutions. The grid is intended to help practitioners easily identify lens-solution combinations that are more likely to cause clinically insignificant or significant corneal staining.

1. The Staining Grid:
A Summary of Ocular
Responses to Lenses and
Solutions Compatibility
Gary Andrasko, O.D., M.S.
Columbus, Ohio

2. Now
 Around 2000 silicone hydrogels introduced
 Better oxygen transmission
 Less protein / more lipid deposits
 Incompatibilities with some solution
preservatives

3. Previous Studies Indicate
Some Multipurpose solutions, when used with
some lens material, including newer Silicone
Hydrogel materials, some may induce clinically
significant…
Corneal Staining.

4. MPS Preservatives
Solution Preservative Manufacturer
Opti-Free Express Polyquaternium-1 Alcon
POLYQUAD
(POLYQUAD &
ALDOX)
RepleniSH Polyquaternium-1 Alcon
(POLYQUAD &
ALDOX)
ReNu MultiPlus Polyaminopropyl biguanide B&L
(DYMED)
BIGUANIDES
AQuify Polyhexanide Ciba Vision
(PHMB)
Complete Moist. Plus Polyhexamethylene AMO
Complete MPS biguanide (PHMB)
Walmart/Target Polyaminopropyl biguanide B&L
CVS/Walgreen MPS (DYMED)
(Renu Multi- Plus)

5. Warning
Some lens/solution combinations especially when
used with silicone hydrogel lenses cause toxic
keratitis.
 Discomfort
 Redness
 Loss of intact epithelial barrier function
 Discontinuation of lens wear
Which are the incompatible combinations?

6. Scientific evidence…
1997
 Jones L, Jones D, Houlford M. Clinical Comparison of Three polyhexanide-
preserved disinfecting solutions. Contact Lens Ant. Eye 1997;20(1)23-30.
 Caroline P, Campbell R. Multipurpose Non-Keratitis. Spectrum March1997.
2002-2003
 Epstein A.B. SPK with Daily Wear of Silicone Hydrogel Lenses and MPS.
Contact Lens Spectrum. 2002;17(11): 30.
 Jones L, MacDougall N, Sorbara LG. Asymptomatic Corneal Staining with
the use of Balafilcon Silicone-hydrogel Contact Lenses Disinfected with
Polyaminopropyl Biguanide-preserved Care Regimen. Optom Vis Sci 2002,
Dec;79(12):753-61.
 Young G, Pritchard N, Hunt C, Coleman S. Subjective and Objective
Measures of Corneal Staining Related to Multipurpose Care Systems. Contact
Lens & Anterior Eye 26 (2003) 3-9.

7. Even more scientific evidence…
 Lebow KA, Schachet JL. Evaluation of corneal
staining and patient preference with use of three
multi-purpose solutions and two brands of soft
contact lenses. Eye Contact Lens. 2003;29(4):213-
20.
2005
 Garofalo R, Dassanayake D, Carey C, Stein J,
Stone R, David R. Corneal Staining and
Subjective Symptoms with Multipurpose Solutions
as a Function of Time. Eye & Contact Lens
2005;31(4): 166-174
 Dassanayake N, Garofalo R et. al. Correlating
Biocide Uptake and Release Profiles with Corneal
Staining and Subjective Symptoms. ARVO 2005
2007
 Carnt N, Wilcox M, Evans V, Naduvilath T,
Tilia D, Papas E, Sweeney D, Holden B.
Corneal Staining: The IER Matrix Study. Contact
Lens Spectrum 2007;22(9):38.

8. Multiple Studies
 11 different solutions
 9 different lens materials
 Looked at comfort and staining
 One masked observer
 Randomized order of solution testing
 N=30 for each combination

9. Study Procedures
 Successful hydrogel CL wearers
 CL soaked in solution overnight-precycled cases
 Baseline exam
 CL inserted
 2 & 4 hour exam
 Rated comfort and symptoms (100-point scale)
 Examined cornea for staining
 NaFl with cobalt and Wratten (yellow) filter

10. Staining Scales
 Staining TYPE
1. Micropunctate
2. Macropunctate
3. Coalesced
4. Patch
 Staining AREA
 Divided cornea
into 5 sectors
 0% to 100% in
10% increments

11. Corneal Staining Example
Area
A (Central): 0%
B (Superior): 0%
C (Temporal): 10%
D (Nasal): 0%
E (Inferior): 0%
Total 10%
Total Avg. Corneal
Staining Area = 2%
OD (10% / 5 = 2%)

12. Corneal Staining Example
Area
A (Central): 30%
B (Superior): 0%
C (Temporal): 10%
D (Nasal): 0%
E (Inferior): 10%
Total 50%
Total Avg. Corneal
Staining Area = 10%
OS (50% / 5 = 10%)

13. Corneal Staining Example
Area
A (Central): 0%
B (Superior): 70%
C (Temporal): 50%
D (Nasal): 40%
E (Inferior): 30%
Total 190%
Total Avg. Corneal
Staining Area = 38%
OD (190% / 5 = 38%)

14. Study Results
 Preformed nearly 3000 patients visits
 Majority of staining was micropunctate
 Heavier staining can be coalesced
 Staining evident soon after lens insertion
 Peaks at 2 hrs.

15. Important Message
Nearly impossible to predict (and remember)
which lens/solution combinations will cause
unacceptable/marginal staining.
Staining Grid!

16. Staining Grid
Unisol 4 Clear Optifree Optifree Renu Complete Walmart Target CVS Walgreen
Aquify
Saline Care Express Replenish MPlus Easy Rub MPS MPS MPS MPS
Acuvue 2
ProClear
Soflens 66
Advance
Oasys
Biofinity
PureVision
O2 Optix
N&D
Last Updated: H2O2 POLYQUAD BIGUANIDES
June 17, 2008

17. Staining Grid
Unisol 4 Clear Optifree Optifree Renu Complete Walmart Target CVS Walgreen
Aquify
Saline Care Express Replenish MPlus Easy Rub MPS MPS MPS MPS
Acuvue 2
ProClear
Soflens 66
Advance
Oasys
Biofinity
PureVision
O2 Optix
N&D
Last Updated: H2O2 POLYQUAD BIGUANIDES
June 17, 2008

18. Staining Grid
Unisol 4 Clear Optifree Optifree Renu Complete Walmart Target CVS Walgreen
Aquify
Saline Care Express Replenish MPlus Easy Rub MPS MPS MPS MPS
Acuvue 2
ProClear
Soflens 66
Advance
Oasys
Biofinity
PureVision
O2 Optix
N&D
Last Updated: H2O2 POLYQUAD BIGUANIDES
June 17, 2008

19. Staining Area
Color Code
 MINIMAL – less than 10% Green
 MARGINAL – 10% to 20% Yellow
 EXCESSIVE – greater than 20% Red
Disclaimer
The colors used in the corneal staining grid are intended only to differentiate the
identified data groupings and are not meant to suggest that the lens-solution
combinations designated red or yellow indicate danger or caution or that such
combinations are associated with an increased risk of corneal infection.

20. Corneal Staining Example
4%
Green Zone
(about 60 dots)

21. Corneal Staining Example
10%
Yellow Zone
(hundred of dots)

22. Corneal Staining Example
76%
Red Zone
(thousands of dots)

23. Staining Grid
Unisol 4 Clear Optifree Optifree Renu Complete Walmart Target CVS Walgreen
Aquify
Saline Care Express Replenish MPlus Easy Rub MPS MPS MPS MPS
Acuvue 2
ProClear 57% 61% 54% 53% 42%
Soflens 66 73% 66% 62% 63% 56%
Advance
Oasys
Biofinity
PureVision 73% 21% 71% 76%
O2 Optix 24% 41% 28% 28% 24%
N&D 24% 36% 24% 26% 22%
Last Updated:
June 17, 2008
H2O2 POLYQUAD BIGUANIDES

24. Renu MultiPlus & PureVision
Coalesced
Staining

25. Renu MultiPlus & PureVision
Coalesced
Staining

26. Target MPS & PureVision

27. Target MPS & PureVision
Micropunctate
Staining

28. Staining Grid
Unisol 4 Clear Optifree Optifree Renu Complete Walmart Target CVS Walgreen
Aquify
Saline Care Express Replenish MPlus Easy Rub MPS MPS MPS MPS
Acuvue 2
ProClear 57% 12% 61% 54% 53% 42%
Soflens 66 73% 17% 66% 62% 63% 56%
Advance 13% 12% 16% 13% 12% 12%
Oasys 12% 13% 10%
Biofinity
PureVision 73% 15% 21% 71% 76%
O2 Optix 24% 41% 28% 28% 24%
N&D 24% 36% 24% 26% 22%
Last Updated: H2O2 POLYQUAD BIGUANIDES
June 17, 2008

29. Walmart MPS & Advance
Macropunctate
Staining

30. Target MPS & Oasys

31. Staining Grid
Branded Solutions Private Label Solutions
Unisol 4 Clear Optifree Optifree Renu Complete Walmart Target CVS Walgreen
Aquify
Saline Care Express Replenish MPlus Easy Rub MPS MPS MPS MPS
Acuvue 2 1% 1% 2% 5% 1% 1% 1% 1% 1% 1% 1%
ProClear 1% 1% 1% 2% 57% 6% 12% 61% 54% 53% 42%
Soflens 66 1% 1% 1% 1% 73% 17% 8% 66% 62% 63% 56%
Advance 1% 1% 1% 1% 13% 12% 2% 16% 13% 12% 12%
Oasys 2% 1% 3% 5% 9% 4% 3% 12% 8% 13% 10%
Biofinity 2% 2% 3% 2% 4% 2% 2% 4% 3% 3% 2%
No Testing No Testing
PureVision 2% 1% 4% 7% 73% 15% 21% 71% 76% Planned Planned
O2 Optix 2% 1% 2% 5% 24% 3% 3% 41% 28% 28% 24%
N&D 2% 1% 2% 3% 24% 1% 3% 36% 24% 26% 22%
Last Updated:
H2O2 POLYQUAD BIGUANIDES
June 17, 2008

32. OptiFree Replenish & O2 Optix

33. OptiFree Express & O2 Optix

34. Walmart MPS & Advance

35. Staining Grid
Branded Solutions Private Label Solutions
Unisol 4 Clear Optifree Optifree Renu Complete Walmart Target CVS Walgreen
Aquify
Saline Care Express Replenish MPlus Easy Rub MPS MPS MPS MPS
Acuvue 2 1% 1% 2% 5% 1% 1% 1% 1% 1% 1% 1%
ProClear 1% 1% 1% 2% 57% 6% 12% 61% 54% 53% 42%
Soflens 66 1% 1% 1% 1% 73% 17% 8% 66% 62% 63% 56%
Advance 1% 1% 1% 1% 13% 12% 2% 16% 13% 12% 12%
Oasys 2% 1% 3% 5% 9% 4% 3% 12% 8% 13% 10%
Biofinity 2% 2% 3% 2% 4% 2% 2% 4% 3% 3% 2%
No Testing No Testing
PureVision 2% 1% 4% 7% 73% 15% 21% 71% 76% Planned Planned
O2 Optix 2% 1% 2% 5% 24% 3% 3% 41% 28% 28% 24%
N&D 2% 1% 2% 3% 24% 1% 3% 36% 24% 26% 22%
Last Updated:
H2O2 POLYQUAD BIGUANIDES
June 17, 2008

36. Staining Grid
Branded Solutions Private Label Solutions
Unisol 4 Clear Optifree Optifree Renu Complete Walmart Target CVS Walgreen
Aquify
Saline Care Express Replenish MPlus Easy Rub MPS MPS MPS MPS
Acuvue 2 1% 1% 2% 5% 1% 1% 1% 1% 1% 1% 1%
ProClear 1% 1% 1% 2% 57% 6% 12% 61% 54% 53% 42%
Soflens 66 1% 1% 1% 1% 73% 17% 8% 66% 62% 63% 56%
Advance 1% 1% 1% 1% 13% 12% 2% 16% 13% 12% 12%
Oasys 2% 1% 3% 5% 9% 4% 3% 12% 8% 13% 10%
Biofinity 2% 2% 3% 2% 4% 2% 2% 4% 3% 3% 2%
No Testing No Testing
PureVision 2% 1% 4% 7% 73% 15% 21% 71% 76% Planned Planned
O2 Optix 2% 1% 2% 5% 24% 3% 3% 41% 28% 28% 24%
N&D 2% 1% 2% 3% 24% 1% 3% 36% 24% 26% 22%
Last Updated:
H2O2 POLYQUAD BIGUANIDES
June 17, 2008

37. Staining Grid
Branded Solutions Private Label Solutions
Unisol 4 Clear Optifree Optifree Renu Complete Walmart Target CVS Walgreen
Aquify
Saline Care Express Replenish MPlus Easy Rub MPS MPS MPS MPS
Acuvue 2 1% 1% 2% 5% 1% 1% 1% 1% 1% 1% 1%
ProClear 1% 1% 1% 2% 57% 6% 12% 61% 54% 53% 42%
Soflens 66 1% 1% 1% 1% 73% 17% 8% 66% 62% 63% 56%
Advance 1% 1% 1% 1% 13% 12% 2% 16% 13% 12% 12%
Oasys 2% 1% 3% 5% 9% 4% 3% 12% 8% 13% 10%
Biofinity 2% 2% 3% 2% 4% 2% 2% 4% 3% 3% 2%
No Testing No Testing
PureVision 2% 1% 4% 7% 73% 15% 21% 71% 76% Planned Planned
O2 Optix 2% 1% 2% 5% 24% 3% 3% 41% 28% 28% 24%
N&D 2% 1% 2% 3% 24% 1% 3% 36% 24% 26% 22%
Last Updated:
H2O2 POLYQUAD BIGUANIDES
June 17, 2008

38. Mechanism of Staining
Amount of staining depends:
 Uptake – Amount of preservative absorbed into the
lens during overnight soak
 Release - Amount & Rate that preservative is
released from the lens to the eye
 Toxicity - How irritating a specific preservative is to
corneal epithelial cells

39. Keys to Diagnosis
 Consult the Staining Grid
 Use fluorescein w/ cobalt & yellow filter
 Look early in wearing period
- within 4 hours of insertion
 Listen to Patient
- discomfort, dryness, red eyes EARLY in day

40. Wratten Filter Advantages
Staining is much easier to visualize using a Wratten Filter

41. So What???
Four Important Questions…
1) Has anyone else found staining?
2) How consistent is staining?
3) What are consequences of staining?
4) How long does staining last?

42. IER Matrix Study

43. IER vs. Staining Grid Results
70
60
Staining Grid - % Subj. in
Shows that 2-hr staining observations
Red/Yellow Zones
50 predict long-term results
40
30
20
10
R2 = 0.81
0
0 5 10 15 20 25
IER Study - % Subj. With Staining

44. So What???
Four Important Questions…
1) Has anyone else found staining?
2) How consistent is staining?
3) What are consequences of staining?
4) How long does staining last?

45. Staining Consistency
PureVision/Renu MultiPlus formulation
100
90
80 Avg. =
70 73%
% Staining
60
50
40
30
20
10
0
1 6 11 16 21 26 31 36 41 46 51 56 61 66 71 76 81 86
Patient #
98% in Red Zone 1% in Yellow Zone 1% in Green Zone

46. So What???
Four Important Questions…
1) Has anyone else found staining?
2) How consistent is staining?
3) What are consequences of staining?
4) How long does staining last?

47. What Does Staining Mean?
Consequences of corneal staining
 Chronic in nature
 Disruption of epithelial barrier layer
 Increase risk of infiltrates
 Discomfort (Staining NOT asymptomatic)
“Wearers who experience corneal disruption as a result of
solution toxicity are three times more likely to experience
such an event (asymptomatic corneal infiltrates and infiltrative
keratitis) than those without staining.”
- Carnt N, Jalbert I, Stretton S, Naduvilath T Papas E. Solution toxicity in soft contact lens
daily wear is associated with corneal inflammation. Optom Vis Sci. 2007Apr;84(4):309-15 .

48. Comfort Score vs. Staining (2 hrs.)
100
90 24-point loss of comfort!
80
70
Comfort Score
60
50
40
30
20
10
0
0 20 40 60 80
Staining Area (%)

49. So What???
Four Important Questions…
1) Has anyone else found staining?
2) How consistent is staining?
3) What are consequences of staining?
4) How long does staining last?

50. Daily Staining Cycle – PV lens
80
Renu MP
70
Saline
60
Staining Area (%)
50
40 End of day observations
30 will MISS signif. staining
20
7 hrs/day
10
0
0 hrs 2 hrs 4 hrs 6 hrs 8 hrs 10 hrs 12 hrs
Time of Wear

51. Closing Thoughts
 Consult the “Staining Grid”
 Examine patients 2-4 hours after insertion
 Recognize that solution is as important as the
contact lens
 Emphasize to patients importance of continuing
to use solution which was prescribed
 Staining affects health and decreases comfort
 Refer to www.StainingGrid.com for updates

52. Common Sense Approach
Recent events of 2006/2007, solution recalls, corneal infections, etc.
have taught us:
 We don’t have all the answers concerning MPS
 Cautious, conservative approach is best
 Minimize all RISK FACTORS (known and suspected)
 corneal staining
 For any lens material, at least 3 solutions are biocompatible
Minimize staining
+ = happy/healthy patients
maximize comfort

53. Avoid the “RED” Combinations

54. THANK YOU!!!