A randomised, placebo controlled clinical trial of the aldose reductase inhibitor CT-112 as management of corneal epithelial disorders in diabetic patients.
OBJECTIVE
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
This was a prospective, randomised, double masked placebo controlled study. 34 eyes of 34 diabetic patients were randomly assigned treatment with 0.25% eye drops 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 between the two groups at any time. 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 = 0.0327; 8 weeks, p = 0.0143).


CONCLUSIONS
The topical aldose reductase inhibitor, CT-112 improves the corneal epithelial barrier function in diabetic patients.
Nakahara
M
M
Meiwakai Medical Foundation, Miyata Eye Hospital, Miyakonojo, Miyazaki, Japan.
Miyata
K
K
Otani
S
S
Miyai
T
T
Nejima
R
R
Yamagami
S
S
Amano
S
S
D000368:Aged; D000449:Aldehyde Reductase / Q000037:antagonists & inhibitors*; D003320:Corneal Ulcer / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology; D003920:Diabetes Mellitus / Q000188:drug therapy*; D004311:Double-Blind Method; D019573:Epithelium, Corneal / Q000378:metabolism / Q000503:physiopathology; D019793:Fluorescein; D015590:Fluorophotometry; D006801:Humans; D008875:Middle Aged; D009883:Ophthalmic Solutions; D010539:Permeability; D011446:Prospective Studies; D012684:Sensory Thresholds; D018709:Statistics, Nonparametric; D045162:Thiazolidinediones / Q000008:administration & dosage* / Q000627:therapeutic use; D013997:Time Factors
D009883:Ophthalmic Solutions; D045162:Thiazolidinediones; C051003:risarestat; D000449:Aldehyde Reductase; D019793:Fluorescein
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