PURPOSE: This study was performed to compare the efficacy, safety and tolerability of diclofenac sodium 0.1% ophthalmic solution with that of prednisolone acetate 1.0% ophthalmic suspension for treatment of inflammation following phacoemulsification and posterior chamber lens implantation. METHODS: One hundred and sixteen patients (diclofenac 57, prednisolone 59) with visually disabling cataract were enrolled in this prospective, randomised, double-masked, parallel group study in two centres. Post-operative patient assessments at day 1, 5-8 and 12-16 included visual acuity, slit-lamp examination, applanation tonometry and subjective evaluation of local tolerance. RESULTS: There was no statistically significant difference between the diclofenac and predisolone groups in the sum of the grades of anterior chamber flare and cells or the degree of conjunctival hyperaemia at any study visit. The overall assessment of local tolerance was similar for both the study medications. There were two (3.4%) possibly drug-related adverse events in the prednisolone group but neither was severe. CONCLUSIONS: Diclofenac sodium 0.01% ophthalmic solution was as effective, safe and well tolerated overall as prednisolone acetate 1.0% ophthalmic suspension.
PURPOSE: This study was performed to compare the efficacy, safety and tolerability of diclofenac sodium 0.1% ophthalmic solution with that of prednisolone acetate 1.0% ophthalmic suspension for treatment of inflammation following phacoemulsification and posterior chamber lens implantation. METHODS: One hundred and sixteen patients (diclofenac 57, prednisolone 59) with visually disabling cataract were enrolled in this prospective, randomised, double-masked, parallel group study in two centres. Post-operative patient assessments at day 1, 5-8 and 12-16 included visual acuity, slit-lamp examination, applanation tonometry and subjective evaluation of local tolerance. RESULTS: There was no statistically significant difference between the diclofenac and predisolone groups in the sum of the grades of anterior chamber flare and cells or the degree of conjunctival hyperaemia at any study visit. The overall assessment of local tolerance was similar for both the study medications. There were two (3.4%) possibly drug-related adverse events in the prednisolone group but neither was severe. CONCLUSIONS: Diclofenac sodium 0.01% ophthalmic solution was as effective, safe and well tolerated overall as prednisolone acetate 1.0% ophthalmic suspension.