A comparison of two different formulations of diclofenac sodium 0.1% in the treatment of inflammation following cataract-intraocular lens surgery

Objective: To compare the efficacy, tolerability and local tolerance of diclofenac sodium 0.1% containing hydroxypropylgamma cyclodextrin preserved with benzalkonium chloride 0.005% (Voltaren® Ophtha CD),1 with that of diclofenac sodium 0.1% preserved with thiomersal 0.004% (Voltaren® Ophtha) in the treatment of inflammation after cataract-intraocular lens surgery. Design and setting: Randomised 2 : 1, double-masked, parallel-group study in six centres in Germany. Study participants: 299 patients scheduled to undergo phacoemulsification with posterior chamber intraocular lens implantation. Interventions: Study medications were instilled four times in the 30 minutes before surgery and four times daily from the first postoperative day. Main outcomemeasures: The key efficacy variable was the reduction in anterior chamber flare (photons/millisecond) from day 1 to day 6 to 8. Patients underwent comprehensive ocular examinations, including laser flaremetry (KOWA), preoperatively and postoperatively at days 1, 6 to 8 and 24 to 32. Results: 268 patients (Voltaren® Ophtha CD 177, Voltaren® Ophtha 91) completed the day 6 to 8 visit without any protocol violations. Reduction in the degree of intraocular inflammation with Voltaren® Ophtha CD was equivalent to that achieved with Voltaren® Ophtha at the day 6 to 8 [95% confidence interval (CI) −3.07 to +0.54] and day 24 to 32 (95% CI −1.44 to +1.40) visits. Although there was no significant (p = 0.464) difference between the two study groups in patients’ global assessment of local tolerance at day 24 to 32, ocular discomfort was significantly (p = 0.023) less with Voltaren® Ophtha CD compared with Voltaren® Ophtha. Conclusions: Voltaren® Ophtha CD was as effective and well tolerated but had less ocular discomfort compared with Voltaren® Ophtha in the treatment of ocular inflammation after phacoemulsification with intraocular lens implantation. This new formulation of diclofenac sodium 0.1% may be used as an alternative to the existing formulations of ophthalmic diclofenac sodium 0.1%.