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PC Donshik, K Sall, L Cacioppo, A Mayhew, R Crockett, R Whitsell, B Yerxa, D Kellerman; Presenting Symptoms from Diary Cards for Dry Eye Clinical Trial Subjects . Invest. Ophthalmol. Vis. Sci. 2002;43(13):3067.
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Purpose:To provide information about the preliminary baseline symptomatology of dry eye disease in a large Phase 3 clinical trial population. Methods:A total of 554 subjects were enrolled and randomized at 34 clinics from a pool of 1040 subjects screened. To qualify for randomization, subjects had to meet entry criteria with respect to corneal staining and Schirmer’s test, and additionally had to report two or more symptoms of at least mild severity in the same eye at screening and again on daily diary cards during the one-week, placebo lead-in period. The candidate symptoms upon which subjects could qualify for entry were itching, burning or pain, foreign body sensation, and photophobia. Results:Subjects were primarily female (76%) and Caucasian (84%), with a mean age (± SD) of 60 (±13) years, and approximately 37% of subjects were over 65 years of age. Approximately one-half (51%) of all subjects qualified for dry eye disease in both eyes based on the study’s entry criteria. Based on weekly average symptom ratings from daily diary recordings, the symptom most often reported as most severe («worst symptom») was foreign body sensation (29%), followed by photophobia (27%), itching (21%), and burning/pain (11%). The remaining subjects reported the four symptoms in a variety of combinations with equal frequency. Based on a 0-4 scale of severity, averages for each of the four symptoms at baseline ranged from 1.44 to 1.64. The average rating of subject’s worst symptom at baseline was 2.12 (± 0.66), with a median of 2.0. The average total symptom score (0-16 scale) was 6.12 (± 2.37) and the median was 5.78. Conclusion:Given a choice of four symptoms to record on a daily diary card, subjects presenting for treatment of dry eye disease appear to record a variety of symptoms as worst. The heterogeneity of these symptom findings are consistent with those from previous studies employing questionnaires for symptom reporting and support the designation of either a worst symptom or composite score as endpoint in clinical trials to better characterize improvement relative to all dry eye patients.
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