Randomized controlled trial of topical mitomycin C for ocular surface squamous neoplasia: early resolution.
OBJECTIVE
To assess the efficacy and safety of mitomycin C in the treatment of ocular surface squamous neoplasia.


METHODS
Prospective, randomized, controlled, masked, single-center trial.


METHODS
Forty-eight consecutive patients with biopsy-proven noninvasive ocular surface squamous neoplasia.


METHODS
Mitomycin C (0.4 mg/ml) or a placebo was administered as 1 drop 4 times a day for 3 weeks, with crossover of drops if there was no regression within 6 weeks.


METHODS
Successful treatment was measured as complete resolution of the neoplasia by slit-lamp examination within 6 to 8 weeks of treatment, with a secondary end point of histological resolution by 6 weeks.


RESULTS
None of 20 in the placebo group resolved clinically, whereas 24 of 26 in the mitomycin group resolved, giving a relative resolution rate of mitomycin versus placebo of 40.87 (95% confidence interval [CI], 1.01-1656.8). There were no complications. There was no statistical treatment effect on histological resolution, with a resolution rate of mitomycin versus placebo of 1.37 (95% CI, 0.34-5.42).


CONCLUSIONS
Mitomycin C (0.4 mg/ml) eyedrops used 4 times a day for 3 weeks is an effective agent to cause early clinical resolution of noninvasive ocular surface squamous neoplasia.
Hirst
Lawrence W
LW
Queensland Eye Institute and University of Queensland, Brisbane, Australia. lawrie.hirst@pbf.org.au
D000287:Administration, Topical; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage*; D002278:Carcinoma in Situ / Q000188:drug therapy* / Q000473:pathology; D003230:Conjunctival Neoplasms / Q000188:drug therapy* / Q000473:pathology; D003316:Corneal Diseases / Q000188:drug therapy* / Q000473:pathology; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005134:Eye Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage*; D011446:Prospective Studies; D016896:Treatment Outcome
D000903:Antibiotics, Antineoplastic; D016685:Mitomycin