BACKGROUND/AIMS: We evaluated the efficacy and safety of long-term management of patients with vernal keratoconjunctivitis (VKC) with bromfenac sodium eye drops in combination with corticosteroids and anti-allergic eye drops. METHODS:Twenty-two patients with VKC were randomly assigned to receive two test eye drops, either bromfenac sodium 0.1% (group A) or placebo eye drops (normal saline; group B) for a mean observation period of 20.9 months. Topical corticosteroids and mast cell stabilizers were continued during the observation period. RESULTS: The mean 2-year recurrence rate was 90.9% in group A and 11.3% in group B, with a significant difference. No serious side effect was observed in group A. CONCLUSION: These results suggest that bromfenac sodium eye drops can be used as baseline local treatment in patients with VKC. Copyright (c) 2007 S. Karger AG, Basel.
RCT Entities:
BACKGROUND/AIMS: We evaluated the efficacy and safety of long-term management of patients with vernal keratoconjunctivitis (VKC) with bromfenac sodium eye drops in combination with corticosteroids and anti-allergic eye drops. METHODS: Twenty-two patients with VKC were randomly assigned to receive two test eye drops, either bromfenac sodium 0.1% (group A) or placebo eye drops (normal saline; group B) for a mean observation period of 20.9 months. Topical corticosteroids and mast cell stabilizers were continued during the observation period. RESULTS: The mean 2-year recurrence rate was 90.9% in group A and 11.3% in group B, with a significant difference. No serious side effect was observed in group A. CONCLUSION: These results suggest that bromfenac sodium eye drops can be used as baseline local treatment in patients with VKC. Copyright (c) 2007 S. Karger AG, Basel.