J ALLERGY CLIN IMMUNOL

VOLUME 133, NUMBER 2

Abstracts AB279

ESDAY

962 Cetirizine Significantly Relieves Ocular Allergy Symptoms InSubjects With Seasonal Allergic Rhinitis

Dr. Mitesh Patel, PharmD1, Dr. Eduardo Urdaneta, MD1, Ms. Kathleen

B. Franklin, BSN, RN2, Ms. Xiaoyan Tian, MS3, Dr. Mei-Miau Wu, Dr

PH4, Ms. Qiong Du, MS3; 1McNeil Consumer Healthcare, Fort Washing-

ton, PA, 2Franklin Consultants, LLC., Phoenixville, PA, 3Johnson & John-

son Consumer Products, China, Shanghai, China, 4J & J Consumer

Products, US, Morris Plains, NJ.

RATIONALE: Evaluate the efficacy of cetirizine for ocular allergy

symptom relief in subjects with seasonal allergic rhinitis (SAR).

METHODS: Seven randomized placebo-controlled SAR studies of

cetirizine 5, 10, or 20 mg daily were evaluated post hoc. Total ocular

symptom score (TOSS) was evaluated in each study. TOSS was sum of the

severity scores for itchy eyes and watery eyes in all studies; one study also

included red eyes. Individual symptom scores were rated on a 4-point scale

(05none to 35severe). Subjects with baseline itchy eye scores >_1 were

included in the analysis. Changes from baseline in TOSS over a 2-week

treatment period, by day in the first week, and weekly were assessed.

RESULTS: Over a 2-week treatment period, mean changes from baseline

in TOSS for the cetirizine groups (N51255) ranged from -2.11 to -2.65 for

5mg, -1.26 to -2.63 for 10mg, and -2.97 for 20mg, representing

improvement relative to baseline of 50% to 67.4% for 5mg, 35.1% to

62.2% for 10mg, and 61.2% for 20mg. Compared with placebo (N5878),

TOSS improvements were statistically superior in 5 studies. In these

studies, treatment effect size ranged from 0.52 to 0.62 for 5mg, 0.40 to 0.58

for 10mg, and 0.78 for 20mg. First week by-day analysis showed significant

improvements in TOSS for cetirizine subjects comparedwith placebo in the

majority of studies.Weekly TOSS inweeks 1 and 2 for the cetirizine groups

were significantly reduced compared with placebo in 5 studies.

CONCLUSIONS: Cetirizine 10mg once daily effectively relieves ocular

allergy symptoms in subjects with SAR.

963 Cetirizine Effectively Relieves Both Ocular Allergy Symptomsand Nasal Allergy Symptoms In Subjects With SeasonalAllergic Rhinitis

Dr. Eduardo Urdaneta, MD1, Ms. Xiaoyan Tian, MS2, Dr. Mei-Miau

Wu, Dr PH3, Ms. Qiong Du, MS2, Ms. Kathleen B. Franklin, BSN,

RN4, Dr. Mitesh Patel, PharmD1; 1McNeil Consumer Healthcare, Fort

Washington, PA, 2Johnson & Johnson Consumer Products, China,

Shanghai, China, 3J & J Consumer Products, US, Morris Plains, NJ,4Franklin Consultants, LLC., Phoenixville, PA.

RATIONALE: Evaluate efficacy of cetirizine 10mg daily for ocular and

nasal allergy symptom relief in subjectswith seasonal allergic rhinitis (SAR).

METHODS: Six randomized placebo-controlled SAR studies of cetir-

izine 10mg daily were evaluated post hoc. Total ocular symptom score

(TOSS) and total nasal symptom score (TNSS) changes were assessed for

each study. TOSSwas sum of severity scores for itchy eyes andwatery eyes

in all studies; one study also included red eyes. TNSS was sum of severity

scores for sneezing, runny nose, itchy nose in all studies; two studies also

included post-nasal discharge. Individual symptom scores were rated on 4-

point scale (05none to 35severe). Subjects with baseline itchy eye score>_1 were assessed for TOSS and subjects with baseline itchy nose score >_1

for TNSS. Changes from baseline in TOSS and TNSS over a 2-week

treatment period, by day in first week, and weekly were assessed.

RESULTS: Over 2 weeks, mean changes from baseline in cetirizine 10mg

groups (TOSS, N51255; TNSS, N5921) ranged from -1.26 to -2.63 in

TOSS and from -2.22 to -4.02 in TNSS, representing improvement from

baseline of 35.1% to 62.2% for TOSS and 29.3% to 62.7% for TNSS.

Compared with placebo (TOSS, N5878; TNSS, N5834), TOSS improve-

ments were statistically superior in 4 studies and for TNSS in 5 studies. In

these studies, treatment effect size ranged from 0.40 to 0.58 for ocular

symptoms and from 0.43 to 0.83 for nasal symptoms.

CONCLUSIONS: Cetirizine 10mg daily effectively relieved both ocular

allergy symptoms and nasal allergy symptoms in subjects with SAR.

964 Automated Evaluation Of Conjunctival Provocation TestsMr. Torsten Sehlinger1, Mr. Jaron Zuberbier2, Dr. Oliver

Kuehlert1, Mr. Frank Goergen1, Prof. Torsten Zuberbier3,

Prof. Karl-Christian Bergmann3; 1Bluestone Technology GmbH, Woerr-

stadt, Germany, 2Evangelic High-School Kleinmachnow, Germany,3Allergy-Centre-Charit�e, Berlin, Germany.

RATIONALE: Conjunctival provocation testing is used in clinical trials,

allowing for normalization of conjunctival allergen reactions. The

evaluation of the conjunctival reaction, meaning the categorization of the

reaction’s severance due to the provocation is done manually. Even when

executed by trained personal, this approach allows for variations in the

categorization due to individual misinterpretation. These errors are adding

up in multi-central studies, where several individuals are evaluating

subjects and protocol assumes equal evaluation quality. Currently the

only possible, but cost intensive option is to reduce the error by having each

subject evaluated multiple times by different personal.

METHODS: An automated system able to evaluate conjunctival reactions

in a standardized, reproducible and cost-effective manner should allow for

better and comparable results, even cross-study comparability. Therefore,

an eye monitoring device was developed, able to scan both eyes under

controlled conditions, including lightning, distance and eye movement.

The associated analyzing Software is able to categorize the conjunctival

reaction based on the vascular dilatation of dedicated blood vessels as well

as the change in the general conjunctival redness.

RESULTS: The system developed showed a compatible accuracy in the

evaluation compared to the average results of three trained evaluatingmedical

professionals. No medical professional was needed to perform high quality

results. Since scans are stored, a quality assurance process can be put in place.

CONCLUSIONS: Automated evaluations of conjunctival provocation

tests can help to increase accuracy, comparability and reproducibility,

while simultaneously lowering the overall costs. This would allow for a

more frequent and broader usage of conjunctival provocation testing.

965 Aeroallergen Immunotherapy Reduces Wheal Diameter InSeasonal and Perennial Allergen Intradermal Skin Tests

Mr. Michael Hauk1, Mrs. Barbara A. McGoey, RN1, Mr. Parimal Patel1,

Mrs. Nicole Argenzia, RN1, Dr. Mary Ann Michelis, MD, FAAAAI21Hack-

ensack University Medical Center, Hackensack, NJ.2Center for Allergy,

Asthmaand ImmuneDisordersHackensackUniversityMedicalCenter,Hack-

ensack, NJ.

RATIONALE: Aeroallergen Immunotherapy (IT) is used to relieve

persistent symptoms of allergic rhinitis, asthma, and allergic conjunctivitis.

This study determines efficacy of IT in desensitizing patients to certain

allergens. We hypothesize IT treatment would show decreases in wheal

diameter in seasonal and perennial allergen intradermal skin tests (SKT).

METHODS: 29 year retrospective chart review on 180 patients ages 18-

91years, who had >_2 SKT. 120 patients received IT of northeastern pollens,

dust mites, and animal danders; 60 patients, as our control, had no IT. IT

treatments varied between 1-9 allergens, most receiving >_3. Initial SKTwas

compared to current SKT (average 7 years between) to see average changes

in wheal diameter for grass, tree, English plantain, ragweed, dust mites, cat

hair, and dog epithelia. P values were based on the Student’s t test.

RESULTS: 120 IT patients (83 female), average age 52 years (SD515.4),

had allergic rhinitis. 64 asthma, 53 conjunctivitis, 20 atopic dermatitis, and

18 chronic sinusitis. 60 control patients (49 female), average age 56 years

(SD516.4), had allergic rhinitis. 34 asthma, 16 conjunctivitis, 7 atopic

dermatitis, and 9 chronic sinusitis. In IT patients, grass allergen had the

largest average decrease in wheal diameter by 4.2mm, dog had the least

with a decrease by 0.9mm. The control group had an increase in wheal

diameter, such as the grass allergen with an average increase of 2.4mm. All

allergens except cat and dust mites had significant P values (<0.05).CONCLUSIONS: Aeroallergen immunotherapy was effective in reducing

wheal diameter across all allergens with various degrees of efficacy.

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