A double blind placebo controlled group comparative study of ophthalmic sodium cromoglycate and nedocromil sodium in the treatment of vernal keratoconjunctivitis.

Abstract

In a 4 week double masked comparative study, patients received 2% nedocromil sodium (48), 2% sodium cromoglycate (48), or placebo eye drops (42), four times daily, for the treatment of vernal keratoconjunctivitis (VKC). Clinical examinations of eye condition and symptom severity were made before and after a 1 week baseline before starting test treatment, and after 1, 2, and 4 weeks of treatment. Patients kept daily diary card records of symptom severity and concomitant therapy. At the clinic, significant improvements were seen with both active treatments after 2-4 weeks. During the final visit, significant benefits over placebo were recorded for five ocular signs with nedocromil sodium and three with sodium cromoglycate, bulbar and lower tarsal chemosis being better controlled by nedocromil sodium (p < 0.05 v sodium cromoglycate). Diary card trends showed improvement with all three treatments, which was greatest with nedocromil sodium and least with placebo. Compared with placebo, both the active drugs produced statistically significant improvements in general eye condition during weeks 1-2, and nedocromil sodium significantly reduced itching within the first week. Overall, nedocromil sodium had the greatest effect on symptoms, although diary card data revealed no statistically significant differences between the two active drugs. In conclusion, both 2% nedocromil sodium and 2% sodium cromoglycate were effective in controlling VKC when administered four times daily into the eyes, while the marked anti-inflammatory activity of nedocromil sodium was apparent in its more pronounced overall therapeutic effect.