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Br J Ophthalmol 1998;82:39-42 doi:10.1136/bjo.82.1.39
  • Original Article
    • Clinical science

Short term comparative study of topical 2% carteolol with and without benzalkonium chloride in healthy volunteers

  1. Christophe Baudouina,
  2. Christine de Lunardob
  1. aDepartment of Ophthalmology, Ambroise Paré, University of Paris-V René Descartes, France, bCenter of Clinical Pharmacology, Pasteur Hospital, University of Nice, France
  1. Pr Ch Baudouin, MD, PhD, Hôpital Ambroise Paré, 9 av Ch de Gaulle, 92100 Boulogne/Seine, France.
  • Accepted 27 August 1997

Abstract

AIM A crossover, randomised double blind study was undertaken in 30 healthy volunteers, in order to compare the tolerance of 2% carteolol with and without preservative in short term use.

METHODS Complete ophthalmic examinations were performed before and 30, 60, and 180 minutes after instillation of one drop of the solution, and after 3 days of preservative treatment. After a 5 day washout, the same examinations were done with the second drug.

RESULTS Results showed good general tolerance for both formulations. No significant difference in subjective tolerance, corneal aesthesiometry, punctuate keratitis, Schirmer’s test, intraocular pressure (IOP) decrease (about 25% in the two groups at 3 hours, 10% after 3 days of treatment), resting cardiac frequency, or blood pressure was observed. However, break up time was 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 significantly change the break up time (baseline 9.08 (5.7) seconds; 3 hours = 7.88 (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 showed better stability of the tear film, without loss of effect on IOP. This difference, although mild in the healthy young subjects in the present study could be much more relevant in those patients treated long term, older patients, and/or those suffering from ocular surface disorders. In such instances, preservative free drugs could be of potential benefit to protect the lacrimal fluid integrity and corneoconjunctival surface.

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