SHORT-TERM COMPARATIVE-STUDY OF TOPICAL 2-PERCENT CARTEOLOL WITH AND WITHOUT BENZALKONIUM CHLORIDE IN HEALTHY-VOLUNTEERS

Aim-A crossover, randomised double blind study was undertaken in 30 he althy volunteers, in order to compare the tolerance of 2% carteolol wi th and without preservative in short term use. Methods-Complete ophtha lmic examinations were performed before and 30, 60, and 180 minutes af ter instillation of one drop of the solution, and after 3 days of pres ervative treatment. After a 5 day washout, the same examinations were done with the second drug. Results-Results showed good general toleran ce for both formulations. No significant difference in subjective tole rance, corneal aesthesiometry, punctuate keratitis, Schirmer's test, i ntraocular pressure (IOP) decrease (about 25% in the two groups at 3 h ours, 10% after 3 days of treatment), resting cardiac frequency, or bl ood pressure was observed. However, break up time was I;significantly reduced from baseline by preserved carteolol both at 3 hours (10.40 (5 .9) seconds to 6.15 (3.9:) seconds, p=0.001) and after 3 days (7.72 (5 .5) seconds, p=0.04). Preservative free carteolol did not significantl y change the break up time (baseline 9.08 (5.7) seconds; 3 hours = 7.8 8 (5.5) seconds, not significant; day 3 = 8.35 (5.8), non-significant) . Conclusions-These results confirm that carteolol is well tolerated, either with or without preservative. The preservative free group showe d better stability of the tear film, without Ic,ss of effect This diff erence, although healthy young subjects in the present study could be much more relevant ill those patients treated long term, older patient s, and/or those suffering from ocular surface disorders. In such insta nces, preservative free drugs could be of potential benefit to protect the lacrimal fluid integrity and corneoconjunctival surface.