A combined analysis of two studies assessing the ocular comfort of antiallergy ophthalmic agents.

David G Shulman, Larry Amdahl, Camisha Washington, Adrienne Graves

Index: Clin. Ther. 25(4) , 1096-106, (2003)

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Abstract

Many topical agents with similar efficacies are available for the treatment of ocular allergies. In addition to efficacy, comfort is an important criterion because it affects overall patient satisfaction, compliance, and in turn efficacy.The goal of this study was to compare the comfort profiles of permirolast, ketorolac, cromolyn, and nedocromil ophthalmic solutions using combined results from 2 separate clinical trials.Two clinical trials were conducted. Adults with asymptomatic eyes were included in the first study. In this single-center, 7-day, prospective, double-blind, single-dose, crossover, parallel-group study, subjects were randomized to be bilaterally dosed with pemirolast, cromolyn, or ketorolac at each of 3 visits. Study 2 was a single-center, 1-day, prospective, randomized, double-blind, single-dose, contralateral, active-control study in which subjects received pemirolast in 1 eye and nedocromil in the contralateral eye. In both studies, subjects completed a pre- and postinstillation ocular comfort questionnaire: the primary variable was overall ocular discomfort, measured on a 4-point scale original to these studies (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Half-increments were permitted. Secondary variables included burning/stinging, foreign-body sensation, tearing, and photophobia.Forty-five subjects (29 women, 16 men; mean [SD] age, 35.9 [12.6] years) were enrolled in study 1; 48 subjects (30 women, 18 men; mean [SD] age, 33.6 [10.2] years) were enrolled in study 2. In study 1, overall discomfort was significantly lower with pemirolast than with cromolyn (P = 0.001) or ketorolac (P < 0.001). In terms of overall discomfort, the number of subjects with a clinically significant increase (>/=1 unit) in score was significantly lower with pemirolast compared with ketorolac (P = 0.021). Burning/stinging and tearing were also significantly lower with pemirolast than with cromolyn (P < 0.001 and P = 0.014, respectively). Mean changes in score compared with preinstillation were consistently lower with pemirolast than with cromolyn for both burning/stinging (P < 0.001) and tearing (P = 0.014). In study 2, overall discomfort was significantly lower with pemirolast than with nedocromil (P < 0.001). The number of subjects with a clinically significant increase in overall discomfort score was significantly lower with pemirolast than with nedocromil (P = 0.007). No changes in ocular tolerability parameters were reported in either study.In these single-dose studies, pemirolast was found to be significantly more comfortable than cromolyn, ketorolac, or nedocromil.