A double-blind randomized phase II study on the efficacy of topical eye treatment in the prevention of docetaxel-induced dacryostenosis.

BACKGROUND: Dacryostenosis is a common side-effect of weekly docetaxel (Taxotere). We investigate the efficacy of eyedrops containing corticosteroids (CS) versus artificial tears (AT) in patients receiving weekly docetaxel in the prevention of dacryostenosis. PATIENTS AND METHODS: Twenty patients receiving weekly docetaxel were evaluated. Forty eyes were double-blind randomized: AT in one eye and CS in the other eye were administered, six times daily, throughout the docetaxel administration. Patients were assessed for tearing and stenosis at weeks 3, 6, 9 and 26. The primary end point was the incidence of dacryostenosis in each group at 9 weeks.
RESULTS: At 9 weeks, punctal or canalicular stenosis was observed in 9 of 20 (45%) of the CS eyes and 9 of 20 (45%) of the AT eyes. Dacryostenosis was mild in 37 of 40 eyes (93%) and severe in 3 of 40 eyes (8%), with equal distribution in the CS and AT group. Tearing was present in 9 of 20 (45%) of the CS eyes and 8 of 20 (40%) of the AT eyes, of which two eyes without stenosis in each group.
CONCLUSIONS: The incidence of dacryostenosis in patients receiving weekly docetaxel was not different for the AT- and the CS-treated eyes. The dacryostenosis was predominantly mild, not leading to surgical interventions.

RCT Entities:   Population Interventions Outcomes