A Laboratory and Clinical Comparison of National Local Formulation and Universal Formulation of Topical Prednisolone Acetate 1% in Reducing Inflammation After Phacoemulsification

Purpose: To evaluate and compare the pharmacological characteristics and clinical efficacy of two topical steroid prednisolone preparations (Redmond®, prednisolone acetate 1%; and Pred Forte®, prednisolone acetate 1%) in reducing postoperative inflammation in patients having phacoemulsification surgery with IOL implantation, which will support our trust in national products considering it's availability and lower costs compared with universal products. Methods: I- Laboratory Study: Direct microscopic examination of the ophthalmic suspension for both formulations. II- Clinical Study: This study was interventional, prospective, randomized controlled study included 60 eyes of patients undergoing emulsification surgery with IOL implantation. Patients were assigned to one of two treatment groups, The first group (30 eyes) received Redmond® while the second group (30 eyes) received Pred Forte® in addition to standard therapy. Study drug was administered postoperatively every 2 hours while awake for 7 days, then four times daily for 7 days, then twice daily for 7 days, then once daily for 7 days. Clinical efficacy was compared for differences in visual acuity, anterior chamber cells (scale 0-4), fundus and macula, drug's ocular adverse effects: foreign body sensation and irritation (scale 1-3), and intraocular pressure (IOP). Results were compared on day 1, day 3, 1 week, 2 weeks, and 1 month postoperatively. Results: I- Average particle size in ophthalmic suspension for both formulations was (< 1 μm). (Redmond® = 0.95 μm, Pred Forte® = 0.77 μm). II- No statistical differences in clinical efficacy or safety were seen between the two formulations tested at any time point evaluated with respect to visual acuity, anterior chamber cells, fundus and macula, foreign body sensation and irritation, and intraocular pressure (IOP). Conclusions: In this study of routine cataract patients, both prednisolone acetate 1% formulations are comparably effective and safe when administered for the reduction of inflammation after phacoemulsification surgery with IOL implantation. Direct microscopic examination showed that both formulations achieved the condition that particle size in ophthalmic suspension must be less than one micron.