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<005 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 significandy 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. (BrJ Ophthalmol 1994; 78: 365-369) The study was carried out in accordance with the principles of the revised Declaration of Helsinki (Venice, 1983) and all patients or parents gave their written informed consent. PATIENT POPULATIONA total of 138 patients with a diagnosis of VKC, 70% of whom were male, took part in the study. Ages ranges from 3 to 36 years (mean 13-5 years) and the duration of the disease ranged from first attack to 30 years, with a mean of 4-3 years. Characteristics were evenly spread among the treatment groups. Eight patients (four in the nedocromil sodium group and two in each of the other groups) had a history of atopic disease (allergic dermatitis) and four (three nedocromil sodium, one sodium cromoglycate) had a family history of atopic disease. Excluded were contact lens wearers and patients with infective, grossly purulent conjunctivitis, or ophthalmic pathology other than that related to the external eye. Individuals known to be sensitive to the eye drop components benzalkonium chloride, disodium edetate, or riboflavin were also excluded. Systemic corticosteroids and ophthalmic sodium cromoglycate were not to have been used for at least 2 weeks before trial entry. MEDICATIONThe test treatments (2% nedocromil sodium, 2% sodium cromoglycate, and placebo) were supplied as aqueous solutions in similar metered dose packs containing 0-01% benzalkonium chloride and 0-05% disodium ed...

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Two per cent and 4% solutions of sodium cromoglycate eye drops were compared in patients with bilateral vernal keratoconjunctivitis. No difference in efficacy between the two solutions could be detected on the analysis of diary card scores or clinical assessments. The opinions of efficacy and treatment preferences recorded by patients and clinician at the end of the trial were very similar for each solution. Side effects were generally minor, usually relating to stinging following application of the eye drops.