Comparison of the Clinical Performance of the Acuvue Disposable Contact Lens and CSI Lens in Patients With Giant Papillary Conjunctivitis

Comparison of the Clinical Performance of the Acuvue Disposable Contact Lens and CSI Lens in Patients With Giant Papillary Conjunctivitis Frank A. Bucci, Jr., M.D., Marta O. Lopatynsky, M.D., Paul L. Jenkins, M.A., Arthur T. Mackay, 0.0., Doug G. Rickert, 0.0., and Robert M. Gold, 0.0.

Anecdotal reports have suggested that the use of disposable contact lenses is an effective treatment for giant papillary conjunctivitis. In a prospective randomized double-masked study, we compared the clinical performance of the Acuvue (Vistakon, Jacksonville, Florida) disposable contact lens to the traditional daily-wear lens of choice, CSI (Pilkington Barnes Hind, Sunnyvale, California), in 37 patients with previously diagnosed giant papillary conjunctivitis who were examined at one-month intervals for six months. A survey questionnaire for grading symptoms disclosed significant improvement in itching, discharge, and blurred vision in both groups early in the study. Evaluation of patient preference showed that the CSI lens was strongly preferred with regard to lens handling (76% vs 8%). In contrast, the Acuvue lens was strongly preferred with regard to lens comfort (62% vs 11%). For the variable of overall lens preference, there was no significant difference between the two lenses (CSI, 43% and Acuvue, 41%). Multiple regression analysis disclosed that both lens comfort (P < .002) and lens handling (P = .05) contributed significantly to the choices made regarding the dependent variable of overall lens preference. Lens comfort (13 = .71) was observed to be approximately 50% more powerful than lens handling (13 .48). There was no significant difference in the rate or cost of torn lenses between groups,

=

Accepted for publication Dec. 28, 1992. From the Department of Ophthalmology, Albany Medical College, Albany, New York (Drs. Bucci and Lopatynsky, Mr. Jenkins, and Drs. Rickert and Gold); and the Department of Ophthalmology, Imogene Bassett Hospital, Cooperstown, New York (Dr. Mackay). Reprint requests to Frank A. Bucci, [r., M.D., 166 W. Mt. Airy Rd., Shavertown, PA 18208.

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suggesting that the Acuvue lens can withstand the physical manipulation associated with daily-wear use for up to one month. The results of this study suggest that the use of disposable contact lenses for the treatment of giant papillary conjunctivitis is at least as effective as the traditional daily-wear lens of choice. GIANT PAPILLARY CONJUNCTIVITIS affects an estimated 1% to 5% of the 30 million contact lens wearers in the United States.' It is characterized by itching, mucous discharge, lens intolerance, and the development of papillae on the upper palpebral conjunctiva, similar to those typically seen in vernal conjunctivitis. Although the exact origin of giant papillary conjunctivitis is still unknown, the primary pathophysiologic mechanisms are thought to involve mechanical trauma to the upper tarsal conjunctiva by the contact lens.':' and a delayed hypersensitivity response to contact lens deposits.P These mechanisms suggest that an effective treatment of giant papillary conjunctivitis would include the use of contact lenses that minimize both mechanically induced conjunctival trauma and contact lens deposits. A contact lens that combines frequent lens replacement with physical properties that are compatible with the ocular surface would theoretically be effective in treating patients with giant papillary conjunctivitis. Anecdotal reports and uncontrolled studies'v' have frequently suggested that the use of disposable contact lenses is an effective treatment tool for patients with giant papillary conjunctivitis, In a prospective, double-masked, controlled fashion, we compared the clinical efficacy of the Acuvue (Vistakon, Jacksonville, Florida) disposable contact lens to the standard daily-wear lens of choice, CSI (Pilkington Barnes Hind, Sunnyvale, California), in pa-

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tients with chronic giant papillary conjunctivitis.

Patients and Methods Forty-two patients in whom giant papillary conjunctivitis had previously been diagnosed were enrolled and followed up at one-month intervals for six months in a prospective, randomized, double-masked study. A computergenerated list of random numbers was used to randomize the dispensing of a CSI lens (crofilcon A with 38.5% water) to one eye and an Acuvue disposable lens (etafilcon A with 58% water) to the other eye. Enrolled patients were instructed not to use ocular medications throughout the study. Criteria for exclusion from the study included the presence of other ocular diseases, regular use of ocular medications, use of systemic corticosteroids, use of systemic noncorticosteroidal anti-inflammatory medications, and use of cromolyn sodium within four weeks of enrollment into the study. The diagnosis of giant papillary conjunctivitis was confirmed at the initial meeting with each patient. A general ophthalmic and detailed contact lens history was obtained and an ocular examination was performed. Patient histories included data concerning the patient's age, gender, years of contact lens use, years since diagnosis of giant papillary conjunctivitis, the age of their current pair of contact lenses, the hours of contact lens use per day, and their history of seasonal allergies. All lenses were used on a daily-wear basis. Disposable lenses were used for a period of one month. Thus, each patient used six disposable Acuvue lenses and one CSI lens for the entire study period. A uniform system of lens care was provided for each patient. The daily AOSEPT (CIBA Vision, Duluth, Georgia) cleaning and disinfecting system and the weekly Ultrazyme (Allergan, Irvine, California) enzymatic applications were used. The everted upper eyelid was examined at the baseline examination and at the third and sixth follow-up visits. Papillae were ranked from 1 to 7 according to their size and distribution. The grading system for evaluating the papillae on the everted upper eyelid was as follows: grade 1, normal results of examination; grade 2, initial formation of macropapillae (0.3 to 1.0 mm); grade 3, diffuse macropapillae (0.3 to 1.0 mm);

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grade 4, diffuse macropapillae (0.3 to 1.0 mm) and giant papillae (greater than 1.0 mm) covering most of the lower one third of the everted upper eyelid; grade 5, giant papillae (greater than 1.0 mm) covering most of the lower two thirds of the everted upper eyelid; grade 6, diffuse giant papillae (greater than 1.0 mm) covering all areas of the everted upper eyelid; and grade 7, giant papillae (greater than 1.0 mm) observable without the slit lamp. Patients were unaware that one of their lenses was a disposable contact lens. After both lenses had been removed, ocular examinations were performed by two independent examiners who were masked to the type of lens. Each patient was informed that lenses would be examined at each visit. A new disposable contact lens was exchanged for the old disposable lens before the lens case was returned to the patient. A survey questionnaire with 15 symptom questions for each eye was completed at each follow-up visit. The 15 symptoms tested included the following: 1. Itching, frequency on lens removal. 2. Itching, degree on lens removal. 3. Itching, frequency throughout the day. 4. Itching, degree throughout the day. 5. Mucous discharge, degree in the morning. 6. Mucous discharge, degree while wearing lenses. 7. Blurred vision, degree overall. 8. Lens awareness, degree overall. 9. Lens movement, degree overall. 10. Pain or discomfort, frequency on lens insertion. 11. Pain or discomfort, degree on lens insertion. 12. Pain or discomfort, frequency throughout the day. 13. Pain or discomfort, degree throughout the day. 14. Pain or discomfort, frequency on lens removal. 15. Pain or discomfort, degree on lens removal. The function of the questionnaire was to rank the degree or frequency of various symptoms related to giant papillary conjunctivitis including itching, discharge, blurred vision, lens movement, lens awareness, and pain or discomfort. Each symptom was ranked from 1 to 9 at each follow-up visit. At the sixth follow-up visit, an additional questionnaire that evaluated patient preference was completed. This questionnaire asked each

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patient to state if they preferred either the left lens, or the right lens, or if they had no preference for the following three variables: lens handling, lens comfort, and overall preference. The total number of torn lenses for each lens type was recorded. The individual cost per torn lens and the total lens replacement costs for each type of lens were also recorded. The replacement cost for the CSI lens was based on a typical discounted replacement cost. The nonparametric ranked data from the symptom survey questionnaire and the grading system for the papillae on the everted eyelid were statistically analyzed. by the Friedman analysis of variance for nonparametric data, the Wilcoxon matched pairs signed rank test, and the median test. The data from the patient preference evaluation were first analyzed by the parametric one-sample paired t-test to screen for significant differences in the data. The Wilcoxon matched pairs signed rank test was then used to confirm the detection of true differences while meeting the criteria required for ordinal scaled data. Multivariate regression analysis was also performed on the patient preference evaluation data. The significance and relative contribution of lens comfort and lens handling (independent variables) toward the choices made regarding overall lens preference (dependent variable) were analyzed.

The average number of hours per day the patients were wearing their contact lenses before entering the study was 11 hours (range, five to 20 hours). Nineteen percent of patients had history of seasonal allergies. No significant changes in the size and distribution of papillae on the everted upper eyelid were observed at three or six months for either lens type. No episodes of acute giant papillary conjunctivitis occurred throughout the study. The Friedman analysis of variance analyzed the change of each symptom variable over time for each lens type. It did not directly compare the responses between each lens type. This analysis disclosed statistically significant improvements for both lens types for all four itching variables after three months of followup (Table 1). The trend of significant changes within both lens groups for the symptom of itching continued through five follow-up periods. Two itching variables persisted in showing significant improvement over time for each lens type (Table 1). Significant improvements were also observed for both lens types for the variables of discharge and blurred vision, but only through one follow-up period. The Wilcoxon matched pairs signed rank test, which analyzed the significance of changes between each interval for each lens type, confirmed the early and relatively equal improvement for the variables of itching, discharge, and

Results

TABLE 1 COMPARISON OF THE CSI AND ACUVUE LENSES FOR THE SYMPTOM OF ITCHING AT THREE AND FIVE MONTHS (ANALYSIS OVER TlME*)

Forty-two patients initially had a CSl lens randomly assigned to placement in one eye and an Acuvue lens placed in the opposite eye. Loss of patients to follow-up was not a problem, as 42 patients completed three months of the study, 41 patients completed five months, and 37 patients completed the entire six months. The mean age of the patients in this study was 29 years (range, 18 to 41 years). There were 13 men and 29 women. The mean number of years that patients had been wearing contact lenses was eight years (range, one and one half to 17 years). The mean number of years since giant papillary conjunctivitis had been diagnosed in the patients was two and one half years (range, zero to six years). The mean age of the pair of lenses the patients were wearing just before entering the study was eight months (range, three months to two and one half years).

THREE·MONTH

FIVE· MONTH

FOLLOW-UP

FOLLOW-UP

(N

(N

= 41)

ACUVUE

CSI

ACUVUE

7.36

13.10

7.87

x2 =

P = .003t 6.67

.025t 6.09

.004t 6.49

.048t 7.79

x2 =

P = .036t 9.96

.048t 6.01

.090 10.81

.049t 5.81

P = .007t X 2 = 7.94

.050t 6.05

.013t 7.51

.121 5.26

P = .019t

.049t

.056

.154

SYMPTOMS

Frequency of itching on lens removal Degree of itching on lens removal Frequency of itching during the day Degree of itching during the day

= 42)

CSI

x

2

= 11.35

"Friedman analysis of variance for nonparametric data. tStatistically significant.

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TABLE 2 ANALYSIS' OF IMPROVEMENTS IN ITCHING, DISCHARGE, AND BLURRED VISION BETWEEN THE BASELINE AND FIRST FOLLOW-UP VISITS FOR THE CSI AND ACUVUE LENSES SYMPTOM SYMPTOMS

RANKING'

CSI

ACUVUE

Frequency of itching on removal of the lens

1< B 1> B 1 =B

Degree of itching on removal of the lens

1< B 1> B 1=B

17 3 22 P = .04* 16 4 22 P = .06§

Frequency of itching during the day

1< B 1> B 1 =B

Degree of itching during the day

1< B 1> B 1=B

Degree of blurred vision

1< B 1> B 1 =B

Degree of discharge in morning

1< B 1> B 1=B

14 5 23 P = .03* 13 6 23 P = .08§ 12 5 25 P = .04* 9 7 26 P = .15 12 5 25 P = .02* 15 6 22 P = .04*

17 5 20 P = .01* 16 5 21 P = .07§ 10 3 29 P = .01* 18 4 20 P = .01*

'Wilcoxon matched pairs signed rank test. '1 < B indicates symptom ranking at first follow-up visit was less severe when compared to the ranking at baseline; 1 > B indicates symptom ranking at first follow-up visit was more severe when compared to the ranking at baseline; 1 = B indicates symptom ranking at first follow-up visit was equal to the ranking recorded at baseline. *Statistically significant improvement. §Approaching statistically significant improvement.

blurred vision for both lens types (Table 2). Four of four itching variables approached or reached significant improvement for the CSI lens between the baseline readings and the first follow-up visit. Three of four itching variables approached or reached significant improvement during this same time period for the Acuvue lens. Similar but less dramatic improvements were observed for itching in both lens groups between the one-month and twomonth follow-up periods. The Friedman analysis and the Wilcoxon test failed to show significant changes for any variables other than itching, discharge, and blurred vision. No changes over time within each group

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were detected for lens awareness, lens movement, or pain. The median test, which provided a direct comparison of responses between lens types, disclosed no significant differences for any symptom question at any follow-up period. At six months, the patient preference evaluation questionnaire analyzed patient preferences with regard to lens handling, lens comfort, and overall lens preference (Table 3). The CSI lens was preferred 76% to 8% (16%, no preference) with regard to lens handling. The Acuvue lens was preferred 62% to 11% (27%, no preference) with regard to lens comfort. There was no significant difference between lens types (43%, CSI vs 41 %, Acuvue) for the variable of overall lens preference. Multiple regression analysis disclosed that both independent variables, lens comfort (P < .002) and lens handling (P = .05), contributed significantly to the choices made regarding the dependent variable of overall lens preference (Table 4). The regression coefficients for each variable suggested that lens comfort (~ = .71) was approximately 50% more powerful than lens handling (~ = .48). The use of the Acuvue lens when used on a daily-wear basis in patients with giant papillary conjunctivitis was addressed by recording the number of torn lenses reported during the six-month period. Eighteen Acuvue lenses and 11 CSI lenses were reported torn throughout the study. Although there was no significant difference between the number of torn lenses in each group, caution must be exercised when interpreting these data because of the different replacement interval for each lens type. For example, during the last week of the study, a CSI lens had undergone almost six months of daily physical manipulation, whereas an Acuvue lens had been exposed to less than four TABLE 3 PATIENT PREFERENCE EVALUATION FOR LENS HANDLING, LENS COMFORT, AND OVERALL LENS PREFERENCE IN 37 PATIENTS AT THE SIX-MONTH FOLLOW-UP VISIT (ACUVUE VS CSI)

Lens handling Lens comfort Overall lens preference

ACUVUE

CSI

NO

PREFERRED

PREFERRED

PREFERENCE

NO.(%)

NO.(%)

NO.(%)

3 (8) 23 (62) 15 (41)

28 (76) 4 (11) 16 (43)

6 (16) 10 (27) 6 (16)

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TABLE 4 MULTIVARIANT REGRESSION ANALYSIS FOR THE CONTRIBUTION OF LENS HANDLING AND LENS COMFORT IN THE CHOICE OF OVERALL LENS PREFERENCE REGRESSION COEFFICIENT

STANDARD ERROR OF THE COEFFICIENT

P VALUE

Lens comfort

.71

Lens handling

.48

.20 .22

.002' .050'

'Significant contribution to overall lens preference.

weeks of manipulation. Nevertheless, after comparing the actual number of torn lenses in each group over the six-month study period, the data support the idea that the Acuvue disposable contact lens can withstand the physical manipulation associated with daily-wear use for up to one month. The cost of replacing 18 Acuvue lenses at $3.75 per lens is $67.50. The cost of replacing 11 CSI lenses at an assumed typical discounted replacement cost of $20.00 per lens is $220.00. Our results disclosed the following: (1) a significant but relatively equal improvement for itching, discharge, and blurred vision in both lens groups; (2) both lens handling and lens comfort contribute significantly to the choice of overall lens preference; (3) the CSI lens was clearly preferred with regard to lens handling, and the Acuvue lens was clearly preferred with regard to lens comfort; (4) there was no significant difference for overall lens preference; (5) the Acuvue lens meets the physical requirements of daily-wear use; and (6) the Acuvue disposable contact lens used on a daily-wear basis is at least as effective in treating patients with chronic giant papillary conjunctivitis as the traditional lens of choice (CSI).

Discussion

Contact lens-induced giant papillary conjunctivitis is an ocular inflammatory condition linked to the deposition of denatured proteins on the surface of contact lenses. Ocular immune responses in monkeys wearing lenses from patients with giant papillary conjunctivitis suggest that an antigenic stimulus in the lens biolayer induces an immune reaction.' Frequent lens replacement can periodically reduce the

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antigenic load presented to the ocular surface and interrupt this aspect of the pathophysiologic mechanism of giant papillary conjunctivitis. Our study and another study" showed dramatic improvements in itching and other type I hypersensitivity-related symptoms soon after the introduction of a clean lens of almost any type. One study" demonstrated a dramatic improvement in itching even while more mechanically related symptoms such as lens movement, lens awareness, and pain significantly worsened.t More recent studies!" support a more multifactorial pathophysiologic mechanism for giant papillary conjunctivitis and may help explain why itching can significantly improve while mechanically related symptoms simultaneously decline. These studies'" demonstrate that physical trauma to conjunctival epithelial cells induced by contact lenses stimulates the production of neutrophil chemotactic factors. These factors are well-known mediators of inflammation through the initiation and amplification of the body's response to biologic trauma. The upper eyelid blinks more than 20,000 times per day. The potential for traumatic injury to the conjunctival tissues is enormous, especially if a less-than-optimum contact lens fit or edge design is being tolerated. Neutrophil chemotactic activity has been detected in the tears of patients with giant papillary conjunctivitis at 15 times the level detected in healthy patients." This finding suggests that an effective strategy for treating giant papillary conjunctivitis would include the use of contact lenses that minimize both contact lens deposits and conjunctival trauma. Our results indicate that the overall clinical performance of the Acuvue and CSI lenses in patients with giant papillary conjunctivitis was essentially equal. The equivalent clinical performance appears to hinge on a trade-off between the variables of lens comfort and lens handling. Multivariate regression analysis disclosed that lens comfort was approximately 50% more powerful than lens handling in relation to overall lens preference. The fragile design of the Acuvue lens may help explain the clinical performance of the lens with regard to both independent variables tested (lens handling and lens comfort). The Acuvue lens disclosed a significant disadvantage on testing for lens handling. Clinicians and patients have both reported that the excessive flexibility of the Acuvue lens can frequently obscure its proper orientation before insertion. This char-

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Disposable Lenses and Giant Papillary Conjunctivitis

acteristic of the Acuvue lens probably explains its relatively poor performance with regard to lens handling and the higher number of torn lenses. In contrast, the delicate nature of the Acuvue lenses is also probably partially responsible for its outstanding clinical performance regarding the powerful variable of lens comfort. The larger regression coefficient for lens comfort may suggest that the physical design of a contact lens may be more important in patients with giant papillary conjunctivitis than controlling contact lens deposits through frequent lens replacement. However, it is still unclear whether the Acuvue lens scored well with regard to lens comfort because of the physical properties and design of the lens, or because a more frequently replaced lens was present on the ocular surface. Subsequent studies (Bucci, F. A., [r., Lopatynsky, M. 0., and Zloty, P., unpublished data, "The Clinical Performance of the Acuvue, NewVues, and SeeQuence Disposable Contact Lenses in Giant Papillary Conjunctivitis," presented as a poster at the Contact Lens Association of Ophthalmologists meeting, January 1992) comparing three disposable contact lenses (Acuvue, Vistakon; NewVues, CIBA Vision, Atlanta, Georgia; and Seequence, Bausch & Lomb, Rochester, New York) in patients with giant papillary conjunctivitis also showed a relatively greater influence for the lens comfort variable compared to lens handling and other variables. The Acuvue lens again scored poorly with regard to lens handling compared to the other two disposable lenses. The NewVues lens had equivalent scores for lens comfort compared to the Acuvue lens, but was statistically significantly preferred to the Acuvue lens with regard to lens handling. We evaluated the use of disposable lenses in patients with giant papillary conjunctivitis compared to the clinical lens of choice (CSI). The Acuvue lens is actually an extended-wear lens that has been adapted for daily wear in patients with giant papillary conjunctivitis who obviously cannot tolerate extended wear. Although the Acuvue lens did not perform well with regard to lens handling, the durability of the lens when used on a daily-wear basis for a relatively long interval (one month) was more than adequate. The torn lens rate did not result in excessive replacement costs compared to the CSI lens. The patients examined in this study had

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chronic, frequently long-standing problems with giant papillary conjunctivitis. Patients with acute attacks of giant papillary conjunctivitis also might derive additional benefits from disposable lenses. Acute attacks of giant papillary conjunctivitis usually result in a variable time period when lens wear is discontinued. A disposable lens can be introduced without excessive concern about having to discard the lens if it is not initially tolerated. Also, the lens turnover time can be gradually titrated upward from days to weeks as lens wear is reintroduced. Thus, a new lens is delivered to the ocular surface more frequently during the critical period.

References 1. Allansmith, M. R., Korb, D. R., Greiner, ]. V., Henriquez, A. S., Simon, M. A., and Finnemore, V. M.: Giant papillary conjunctivitis in contact lens wearers. Am.]. Ophthalmol. 83:697, 1977. 2. Ehlers, W. H., Donshik, P. C., Gillies, c., Forouhar. F., Allan, M. D., Williams, W., and Elegbaly, S. A.: The induction of an inflammatory reaction (similar to giant papillary conjunctivitis) by chemotactic factors derived from conjunctival cells. ARVO abstracts. Supplement to Invest. Ophthalmol. Vis. Sci. Philadelphia,]. B. Lippincott, 1990, p. 241. 3. Elgebaly, S. A., Donshik, P. c.. Rahhal, F., and Williams, W.: Neutrophil chemotactic factors in the tears of giant papillary conjunctivitis patients. Invest. Ophthalmol. Vis. Sci. 32:208, 1991. 4. Ehlers, W. H., Fishman, ]. B., Donshik, P. c.. Williams, W., and Elgebaly, S. A.: Neutrophil chemotactic factors derived from conjunctival epithelial cells. Preliminary biochemical characterization. CLAO J. 17:65, 1991. 5. Ballow, M., Donshik, P. c., Rapaz, P., Maenza, R., Yamase, H., and Muncy, 1.: Immune responses in monkeys to lenses from patients with contact lens induced giant papillary conjunctivitis. CLAO J. 15:64,1989. 6. Cho, M. H., Norden, 1. c.. and Chang, F. W.: Disposable extended-wear soft contact lenses for the treatment of giant papillary conjunctivitis. South. ]. Optom. 1:6, 1988. 7. Coursaux, G., Bloch-Michel, E., and Massin, M.: Reequipement avec les lentiIIes jetables de patients porteurs de conjonctivite papillaire geante. Premiers resultats. Bull. Soc. Ophtalmol. Fr. 12:1371, 1989. 8. Bucci, F. A., Jr., Lopatynsky, M. 0., Jenkins, P.L., Rikert, D. G., and Gold, R. M.: The deposit resistant Hydrocurve Elite soft contact lens and giant papillary conjunctivitis. Invest. Ophthalmol. Vis. Sci. 30:256, 1989.