rimexolone and Endophthalmitis

To compare the efficacy and safety of rimexolone 1% and prednisolone acetate 1% ophthalmic suspensions in controlling intraocular inflammation in the early period after cataract surgery.. Eighty patients undergoing cataract extraction with intraocular lens implantation, either planned extra capsular cataract extraction (PECCE) or phacoemulsification surgery, were evaluated in a prospective, randomized, observer-masked, clinical trial in which efficacy in controlling early postoperative inflammation and safety of prednisolone acetate 1% one eye drop every 4 h (n = 36 eyes) was compared with that of rimexolone 1% one eye drop every 4 h (n = 44 eyes) in an eighteen day course. Efficacy was assessed from changes of the anterior chamber cell count, flare, conjunctival hyperemia, and ciliary congestion by means of slit lamp biomicroscopy on days 1, 3, 8, 15, and 18. Intraocular pressure (IOP) and possible side effects were also recorded on each visit.. Anterior chamber cell count and flare showed no difference in the two groups at any visits. The rimexolone group was associated with significantly higher score for conjunctival hyperemia on days one and three (P < 0.05) and the prednisolone acetate group was associated with a significantly higher score for corneal edema on day 8 (P < 0,05). However, there were no between group differences in IOP.. Rimexolone 1% ophthalmic suspension was as effective and safe as prednisolone acetate 1% ophthalmic suspension in controlling inflammation in the early period after cataract surgery.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Anterior Chamber; Anti-Inflammatory Agents; Cataract Extraction; Cell Count; Dose-Response Relationship, Drug; Endophthalmitis; Female; Follow-Up Studies; Humans; Male; Middle Aged; Ophthalmic Solutions; Postoperative Complications; Prednisolone; Pregnadienes; Prodrugs; Prospective Studies; Single-Blind Method; Treatment Outcome

To assess the efficacy and safety of rimexolone 1% ophthalmic suspension in controlling intraocular inflammation after cataract extraction.. Twelve independent investigational centers in the United States. This study comprised 197 patients who had cataract extraction. Postoperatively, patients were randomized to a 2 week regimen of rimexolone 1% ophthalmic suspension or a placebo. Efficacy was analyzed by monitoring total anterior chamber cells and flare, other parameters of inflammation, and treatment failures. Safety was evaluated by monitoring treatment-related adverse events and intraocular pressure (IOP).. Rimexolone 1% was clinically and statistically more effective in suppressing cell and flare than the placebo (P < .02). The overall discontinuation rate for treatment-related adverse events was 5.3% in the rimexolone group and 22.2% in the placebo group. There were no between-group differences in IOP.. Rimexolone 1% ophthalmic suspension was safe and significantly more effective than a placebo in controlling intraocular inflammation after cataract extraction when used four times daily and continued for 2 weeks.

Topics: Administration, Topical; Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents; Double-Blind Method; Endophthalmitis; Female; Humans; Male; Middle Aged; Ophthalmic Solutions; Phacoemulsification; Pregnadienes; Prospective Studies; Safety; Suspensions; Treatment Outcome