The effects of Rimexolone 1% in postoperative inflammation after cataract extraction. A double-masked placebo-controlled study.
OBJECTIVE
A multicentre, randomized, placebo-controlled double-masked study was conducted to assess the efficacy and safety of Rimexolone 1% eye drops in reducing inflammation after cataract surgery and intra-ocular lens implantation.


METHODS
Rimexolone 1% (124 patients) or placebo (58 patients) was given, four times a day for 14 days starting 22-34 hours after surgery. All patients also received tobramycin 0.3% four times a day for 7 days. The clinical signs of ocular inflammation were recorded on days 1, 3, 8, 15 and 17 or 18.


RESULTS
Rimexolone 1% markedly decreased the mean inflammation severity scores, and the sum of clinical assessments of cells and flare in the anterior chamber compared with placebo at each assessment. In addition, the percentage of patients with no anterior chamber inflammation was significantly higher with Rimexolone 1% than with the placebo at each assessment. All these results were statistically significant. Intra-ocular pressure did not rise after treatment with Rimexolone 1%.


CONCLUSIONS
The results suggest that Rimexolone 1% ophthalmic solution is an effective and safe steroidal anti-inflammatory agent for topical use following cataract surgery and intra-ocular lens implantation.
Bron
A
A
Department of Ophthalmology, Faubourg Raines Hospital, Dijon, France.
Denis
P
P
Hoang-Xuan
T C
TC
Boureau-Andrieux
C
C
Crozafon
P
P
Hachet
E
E
Medhorn
E
E
Akingbehin
A
A
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000627:therapeutic use; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D002387:Cataract Extraction / Q000009:adverse effects*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D009877:Endophthalmitis / Q000188:drug therapy* / Q000209:etiology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D019654:Lens Implantation, Intraocular / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions; D011183:Postoperative Complications / Q000188:drug therapy*; D011245:Pregnadienes / Q000008:administration & dosage / Q000627:therapeutic use*; D012449:Safety; D014031:Tobramycin / Q000008:administration & dosage / Q000627:therapeutic use; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D000893:Anti-Inflammatory Agents; D009883:Ophthalmic Solutions; D011245:Pregnadienes; C013769:rimexolone; D014031:Tobramycin