Safety and efficacy of sodium cromoglycate-fluorometholone fixed combination eye drops in allergic conjunctivitis

PURPOSE: This study aimed to assess the efficacy and safety of sodium cromoglycate with fluorometholone in patients with allergic conjunctivitis. METHODS: We conducted a single-arm phase IV open-label trial where fifty patients who received the eye drops were followed for 4 weeks. Treatment efficacy was assessed using the ocular itching score, conjunctival assessment score, total symptom and sign (TSS) score, and Visual Analog Scale (VAS). RESULTS: Patients who received sodium cromoglycate-fluorometholone eye drops experienced significant improvements in their ocular itching score (mean difference [MD]: 1.14, P < 0.001) and conjunctival redness score (MD: 1.18, P < 0.001). Statistically significant improvements in TSS and VAS were achieved in 78% of the patients reporting no conjunctivitis by the end of the study. The overall therapeutic response to the drug was as follows: 16% improved and 84% much improved. No serious adverse events were reported. CONCLUSION: Sodium cromoglycate with fluorometholone eye drops achieved 100% therapeutic response among patients with allergic conjunctivitis. The eye drops improve the ocular itching, and conjunctival irritation without serious adverse events. This combination appears effective and tolerable for treatment of allergic conjunctivitis.