DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



A clinical evaluation of diclofenac-gentamicin combination eye drops in the control of inflammation after cataract surgery. Diclofenac-Gentamicin versus Gentamicin Study Group.

Author(s): Shepherd WF, Fsadni MG, Raj PS

Affiliation(s): Department of Ophthalmology, Borders General Hospital, Melrose, UK.

Publication date & source: 1998-03, Ocul Immunol Inflamm., 6(1):13-8.

Publication type: Clinical Trial; Multicenter Study; Randomized Controlled Trial

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.

Page last updated: 2006-01-31

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017