title: A clinical evaluation of diclofenac-gentamicin combination eye drops in the control of inflammation after cataract surgery. Diclofenac-Gentamicin versus Gentamicin Study Group.
abstract: The purpose of this study was to compare the efficacy and safety of diclofenac-gentamicin (DR 1352/1) combination eye drops with gentamicin eye drops in the postoperative management of patients undergoing extracapsular cataract surgery and lens implantation. This was a prospective, randomised, double-masked, parallel-group, four-week, multicentre study with patient visits preoperatively, on the day of surgery, and postoperatively on days 1, 5-8, 12-16, and 26-32. Of the 196 patients (diclofenac-gentamicin 99, gentamicin 97) recruited into the study, 161 (diclofenac-gentamicin 83, gentamicin 78) were available for per-protocol analyses. The two treatment groups were clinically similar at baseline. On days 12-16 postoperatively, diclofenac-gentamicin was significantly more effective (p = 0.002) than gentamicin in reducing intraocular inflammation as assessed by the sum of grades of anterior chamber cells and flare. The level of conjunctival hyperaemia was significantly less in the diclofenac-gentamicin group compared with the gentamicin group on postoperative days 5-8 and 12-16. There was no significant difference between the two study groups in the global assessment of local tolerance. Possibly drug-related adverse events were slightly more in the diclofenac-gentamicin group (22,22%) compared with gentamicin (17,17%); however, all affected study patients normalised with appropriate therapy except one patient with endophthalmitis. In conclusion, diclofenac-gentamicin (DR1352/1) eye drops were more effective than gentamicin eye drops and appeared to be as safe in the control of post-cataract surgery inflammation.
authors.affiliation: Department of Ophthalmology, Borders General Hospital, Melrose, UK.
authors.forename: W F
authors.initials: WF
authors.lastname: Shepherd
authors.forename: M G
authors.initials: MG
authors.lastname: Fsadni
authors.forename: P S
authors.initials: PS
authors.lastname: Raj
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects / Q000627:therapeutic use*; D002387:Cataract Extraction; D004008:Diclofenac / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D009877:Endophthalmitis / Q000517:prevention & control*; D005260:Female; D005839:Gentamicins / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions; D011183:Postoperative Complications / Q000517:prevention & control*; D011446:Prospective Studies
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D004338:Drug Combinations; D005839:Gentamicins; D009883:Ophthalmic Solutions; D004008:Diclofenac