PURPOSE: To evaluate the analgesic action of combined indomethacin 0.1%/gentamicin eyedrops in traumatic corneal abrasion. METHODS: We evaluated 123 patients presenting traumatic corneal abrasion in a multicentre, randomised, double-masked study comparing two parallel treatment groups: indomethacin/gentamicin (group 1) or gentamicin alone (group 2). Study treatments were administered four times daily for 5-6 days. Pain (visual analogue scale), associated symptoms and safety were assessed. RESULTS: Starting from a comparable level, pain was reduced by 30% in group 1 and 15% in group 2, one hour after the first instillation, and by 59% and 42% respectively after the second. The global difference in pain relief from day 0 to day 4/5 was significantly better in group 1 (p = 0.015). Associated ophthalmic symptoms showed a greater decrease in group 1 after the first instillation (p = 0.007). Both treatments were well tolerated. CONCLUSIONS: Combined indomethacin/gentamicin eyedrops were effective and well tolerated in reducing the pain and discomfort associated with traumatic corneal abrasion.
RCT Entities:
PURPOSE: To evaluate the analgesic action of combined indomethacin 0.1%/gentamicin eyedrops in traumatic corneal abrasion. METHODS: We evaluated 123 patients presenting traumatic corneal abrasion in a multicentre, randomised, double-masked study comparing two parallel treatment groups: indomethacin/gentamicin (group 1) or gentamicin alone (group 2). Study treatments were administered four times daily for 5-6 days. Pain (visual analogue scale), associated symptoms and safety were assessed. RESULTS: Starting from a comparable level, pain was reduced by 30% in group 1 and 15% in group 2, one hour after the first instillation, and by 59% and 42% respectively after the second. The global difference in pain relief from day 0 to day 4/5 was significantly better in group 1 (p = 0.015). Associated ophthalmic symptoms showed a greater decrease in group 1 after the first instillation (p = 0.007). Both treatments were well tolerated. CONCLUSIONS: Combined indomethacin/gentamicin eyedrops were effective and well tolerated in reducing the pain and discomfort associated with traumatic corneal abrasion.