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[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]

Author(s): Arnaud B, Trinquand C

Affiliation(s): Service d'ophtalmologie, Hopital Gui de Chauliac, Montpellier, France.

Publication date & source: 1997, J Fr Ophtalmol., 20(3):183-8.

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

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 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). CONCLUSION: 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.

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