A Randomized, Placebo–Controlled Clinical Trial of the Aldose Reductase Inhibitor CT–112 as Management of Corneal Epithelial Disorders in Diabetic Patients

Abstract

Abstract: : Purpose: To evaluate the efficacy of topical aldose reductase inhibitor CT–112 (5–[3–ethoxy–4–pentyloxyphenyl]–2,4–thiazolidinedione) on corneal epithelial barrier function in diabetic patients. Methods:Thirty four eyes of 34 diabetic patients were randomly assigned treatment with 0.25 % eyedrops of CT–112 (n=22) or a placebo (n=12) four times a day for 8 weeks. Corneal fluorescein staining and corneal sensation were examined before treatment as well as 4 and 8 weeks after administration. Corneal epithelial permeability to fluorescence was measured with an anterior fluorophotometer. Results:Average scores of superficial punctate keratopathy and corneal sensitivity did not differ significantly different between the two groups at any time–point. Whereas average fluorescein concentrations did not differ significantly for the CT–112 and placebo groups before treatment, they did differ significantly 4 and 8 weeks after treatment (4 weeks, p = .0327; 8 weeks, p = .0143). Conclusions: Topical ARI, CT–112 improves the corneal epithelial barrier function in diabetic patients.

Keywords: cornea: epithelium • cornea: clinical science • diabetes