Efficacy of lodoxamide 0.1% ophthalmic solution in resolving corneal epitheliopathy associated with vernal keratoconjunctivitis.
A multicenter, randomized, double-masked, parallel-group study compared the long-term efficacy and safety of lodoxamide 0.1% ophthalmic solution and placebo in 118 patients with vernal keratoconjunctivitis. The test drugs were instilled four times daily for 90 days. Lodoxamide 0.1% ophthalmic solution was significantly (P < .05) more effective than placebo in lowering severity scores for epithelial disease and corneal staining, evidence of the superior efficacy of lodoxamide 0.1% ophthalmic solution in reversing the corneal complications commonly associated with moderate to severe vernal keratoconjunctivitis. Additionally, lodoxamide 0.1% ophthalmic solution ameliorated the other key signs of vernal keratoconjunctivitis, including upper tarsal papillae, limbal signs (papillae, hyperemia, and Trantas' dots), and conjunctival discharge. The between-group differences in the relief of symptoms (itching, tearing, and photophobia) were clinically significant but not always statistically significant. Treatment-related adverse events were reported with similar frequency in both treatment groups, and none were serious.
Santos
C I
CI
University of Puerto Rico School of Medicine, Rio Piedras.
Huang
A J
AJ
Abelson
M B
MB
Foster
C S
CS
Friedlaender
M
M
McCulley
J P
JP
D000293:Adolescent; D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D002648:Child; D002675:Child, Preschool; D003233:Conjunctivitis, Allergic / Q000150:complications / Q000188:drug therapy*; D003316:Corneal Diseases / Q000188:drug therapy* / Q000209:etiology; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions; D010072:Oxamic Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*
D009883:Ophthalmic Solutions; D010072:Oxamic Acid; C021702:lodoxamide ethyl