[Double-blind study on 3 parallel groups of 2 formulations of 0.1% indomethacin and 0.1% diclofenac in preventing and controlling inflammation after cataract surgery].
OBJECTIVE
To evaluate the efficiency and safety of LCM 1110 eyedrops, a new 0.1% indomethacin formulation, compared with the registered 0.1% indomethacin solution and with 0.1% diclofenac, in the management of post cataract surgery inflammation.


METHODS
A total of 352 patients randomly assigned to LCM 1110 (n = 116), to indomethacin (n = 121) or to diclofenac (n = 115) were included in this three-arm, prospective, multicenter and double-masked trial, after giving written informed consent. They were given preoperatively 1 drop QID the day before surgery, 5 drops within 2 hours prior to operation then 1 drop QID for 1 month. Cataracts were extracted by either extracapsular or phacoemulsification methods, with PC-IOL implantation. The main efficacy evaluation was based on the assessments of anterior chamber cells and flare at days 1, 7 and 30 following surgery. Symptoms, other objective signs and IOP were recorded.


RESULTS
Cellular and proteinic Tyndall phenomenon did not significantly differ in the 3 groups, at any of the post surgical assessments. Clinical symptoms and visual acuity improved similarly. IOP was not adversely affected by any drug. Compared with subjects having received LCM 1110, diclofenac-treated patients experienced a superficial punctuate keratitis more frequently. Tolerance of instillation, measured by a visual analogic scale, was best improved by LCM 1110 followed by the indomethacin solution and by diclofenac (LCM 1110-diclofenac; p = 0.004).


CONCLUSIONS
These data suggest that LCM 1110, a new 0.1% indomethacin ophthalmic solution, appears to be a safe promising agent for the control of postoperative inflammation.
Arnaud
B
B
Service d'ophtalmologie, Hôpital Gui de Chauliac, Montpellier, France.
Trinquand
C
C
D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000627:therapeutic use*; D002387:Cataract Extraction / Q000009:adverse effects; D004008:Diclofenac / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007213:Indomethacin / Q000008:administration & dosage / Q000627:therapeutic use*; D007249:Inflammation / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D011184:Postoperative Period; D011292:Premedication; D011446:Prospective Studies
D000894:Anti-Inflammatory Agents, Non-Steroidal; D004008:Diclofenac; D007213:Indomethacin
Etude en double insu sur 3 groupes parallèles de deux formulations d'indométacine à 0.1% et du diclofénac à 0.1% dans la prévention et le contrôle de l'inflammation après chirurgie de la cataracte.