Comparison of the efficacy and safety of a novel meloxicam ophthalmic formulation with a reference diclofenac solution in cataract surgery.
A novel topical ophthalmic formulation of the preferential COX-2 inhibitor meloxicam has recently been developed. The purpose of the present study was to evaluate the efficacy and safety of this novel 0.03% meloxicam solution with regard to a reference 0.1% diclofenac formulation in a prospective, parallel, randomized, multicenter, double-blind study. Two groups of patients submitted to phacoemulsification with intraocular lens implantation were formed. Patients in one group were treated with meloxicam and those in the other group with diclofenac. Dosing was 1 drop t.i.d. for 30 days, beginning the first day after surgery, for both treatments. Inflammation was assessed by the presence of cells in the anterior chamber, anterior chamber flare, ciliary flush, photophobia and pain. Both treatments significantly reduced these indicators. Topical meloxicam and diclofenac produced a similar degree of burning sensation and conjunctival hyperemia. There was no significant difference between treatments in any of the measured parameters. It is concluded that the novel meloxicam solution is effective and safe. Meloxicam, however, did not offer any significant benefit over the diclofenac formulation in patients submitted to cataract surgery.
Baiza-Duran
L M
LM
Clinical Research Department, Laboratorios Sophia S.A. de C.V. Guadalajara, Jalisco, Mexico. drbvista@sophia.com.mx
Quintana-Hau
J
J
Tornero-Montaño
R
R
Ortiz
M I
MI
Castañeda-Hernández
G
G
Alanis-Villarreal
L
L
Avalos-Urzua
G
G
Bustos-Zermeño
R
R
Domene-Hinojosa
J L
JL
Gómez-Bastar
P
P
Ibañez-Hernandez
M A
MA
Morales-Gómez
M E
ME
Velasco-Gallegos
G
G
Villar-Kuri
J
J
D000287:Administration, Topical; D000368:Aged; D000867:Anterior Chamber / Q000378:metabolism / Q000473:pathology; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000009:adverse effects; D004008:Diclofenac / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007249:Inflammation / Q000209:etiology / Q000517:prevention & control*; D019654:Lens Implantation, Intraocular / Q000009:adverse effects; D008297:Male; D000077239:Meloxicam; D008875:Middle Aged; D009883:Ophthalmic Solutions; D018918:Phacoemulsification / Q000009:adverse effects; D011183:Postoperative Complications / Q000517:prevention & control; D011446:Prospective Studies; D013843:Thiazines / Q000008:administration & dosage* / Q000009:adverse effects; D013844:Thiazoles / Q000008:administration & dosage* / Q000009:adverse effects
D000894:Anti-Inflammatory Agents, Non-Steroidal; D009883:Ophthalmic Solutions; D013843:Thiazines; D013844:Thiazoles; D004008:Diclofenac; D000077239:Meloxicam