Nedocromil sodium treats symptoms of perennial allergic conjunctivitis not fully controlled by sodium cromoglycate A double-masked placebo controlled group comparative study

Abstract

In a double-masked group comparative study, 20 patients received 2% nedocromil sodium four times daily and 23 placebo eye drops, for treatment of perennial allergic conjunctivitis (PAC). All had at least a one-year diagnosis of bilateral PAC and remained symptomatic despite using 2% sodium cromoglycate eye drops four times daily for at least 14 days Symptom severity (0-4) during sodium cromoglycate monotherapy was then recorded in a one-week baseline prior to randomisation, a minimum total score of 11 being mandatory. During the trial, no eye medication was allowed other than the test treatment. Clinic examinations were made before and after baseline and after one, three and six weeks' treatment, and patients kept daily diary cards of eye symptom severity. Compared to placebo, nedocromil sodium significantly (p<0.05) improved diary scores for itching (weeks 3, 4, 5, 6), total symptoms (weeks 5, 6) and general eye condition (week 6). Mean scores over the final four weeks, allowing a two-week washout, showed similar improvements in itching (p = 0.01), total symptoms (p = 0.05) and general eye condition (p = 0.04). Clinical assessments again favoured nedocromil sodium, which improved itching (week 3, p = 0.002), burning (week 6, p = 0.007), overall eye condition (weeks 3-6, p<0.05). and conjunctival thickening and hyperaemia (weeks 3-6, p<0.05). Finally, both patient (p = 0.02) and clinician (p = 0.0015) opinions of efficacy favoured nedocromil sodium over placebo. These results show nedocromil sodium to be effective in controlling symptoms of perennial allergic conjunctivitis which persisted during treatment with sodium cromoglycate.

Nedocromil sodium eye drops are more effective than sodium cromoglycate eye drops for the long‐term management of vernal keratoconjunctivitis

“…In one placebo-controlled study, moreover, nedocromil sodium was effective in a group of PAC patients specifically selected for their known lack of response to sodium cromoglycate [26]. The profile of comparative clinical efficacy is consistent with the pharmacological activities of these two mast cell-stabilizing anti-inflammatory compounds, in the light of the cellular inflammatory processes known to underlie allergic eye diseases [7][8][9][10][11][12][27][28][29].…”

“…These were patients with moderate baseline disease of around 50% maximum severity, most having either limbal VKC (or 'tropical limbal conjunctivitis', which appears to have a genetic link for dark-skinned children living in cooler, European regions [21]) or mixed palpebral VKC with limbal proliferations. At our centre in Bordeaux, [25][26][27][28][29][30] children per year currently present with limbal VKC, and 40% of our study population was dark-skinned. Limbal VKC has more corneal complications than the palpebral form and is often associated with intense cellular proliferation which may lead to visual impairment or blindness [5,6].…”

Treating severe eye allergy

“…The effect of nedocromil sodium has been investigated in patients unresponsive to sodium cromoglycate. This was a placebo‐controlled, double‐blind study of nedocromil sodium in a group of patients with PAC, who were selected for their known lack of response to sodium cromoglycate [4]. Following a 2‐week washout period, patients were randomized to nedocromil sodium four times daily or placebo for a further 4‐week treatment period.…”

The treatment of allergic eye disease: has sodium cromoglycate had its day?

“…It responds to the same treatments as SAC [ 6]. One study found that nedocromil was effective in treating symptoms not fully controlled by sodium cromoglycate [ 23].…”