EVALUATION OF DICLOFENAC SODIUM 0.1-PERCENT OPHTHALMIC SOLUTION IN THE TREATMENT OF OCULAR SYMPTOMS AFTER BILATERAL RADIAL KERATOTOMY

Purpose, Patients frequently have ocular pain, photophobia, foreign-bo dy sensation, and burning/stinging after radial keratotomy. This study was a prospective, randomized, double-masked, multicenter, fellow-eye comparison of diclofenac sodium (Voltaren Ophthalmic, 0.1% solution) and placebo for controlling these ocular symptoms after bilateral radi al keratotomy. Methods, Patients who were gain free in both eyes befor e surgery were randomly assigned to treatment with diclofenac sodium i n one eye and placebo in the other. One drop of each masked trial medi cation was administered 30-60 min before surgery, 5 min and 6 h after surgery, at bedtime on the day of surgery, and four times daily for 2 additional days. Patients evaluated ocular symptoms in each eye 0.5, 1 , 2, 4, 6, 24, and 48 h after surgery and provided a global evaluation 6, 24, and 48 h after surgery, For each assessment, the difference in scores between eyes was analyzed by using a paired t test, Results, D iclofenac sodium was significantly (p < 0.001) superior to placebo in controlling each ocular symptom al each interval after surgery and for patient global assessments 6, 24, and 48 h after surgery, Conclusion, Diclofenac sodium 0.1% ophthalmic solution is clinically effective in controlling adverse ocular symptoms occurring after bilateral radial keratotomy.