DOUBLE-MASKED STUDY ON 3 PARALLEL GROUPS OF 2 0.1-PERCENT INDOMETHACIN FORMULATIONS AND 0.1-PERCENT DICLOFENAC IN THE PREVENTION AND CONTROL OF INFLAMMATION SECONDARY TO CATARACT-SURGERY

Purpose 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 ra ndomly assigned to LCM 1110 (n = 116), to indomethacin (n = 121) or to diclofenac (n = 115) were included in this three-arm, prospective, mu lticenter and double-masked trial, after giving written informed conse nt. They were given preoperatively I 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 phacoemulsificati on 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 arty of the post surgical assessments. Clinical symptoms and visual acuity improved similarly. IOP was not adversely affected by any drug. Compared with subjects hav ing received LCM 1110, diclofenac-treated patients experienced a super ficial punctuate keratitis more frequently. Tolerance of instillation, measured by a visual analogic scale, was best improved by LCM 1110 fo llowed by the indomethacin solution and by diclofenac (LCM 1110 - dicl ofenac; p = 0.004). Conclusion These data suggest that LCM 1110, a new 0.1 % indomethacin ophthalmic solution, appears to be a safe promisin g agent for the control of postoperative inflammation.