In 2 clinical trials involved in the development of TRAVATAN eye drops (polyquaternium-1--preserved), 201 patients were exposed for up to 3 months. No serious ophthalmic or systemic undesirable effects related to the product were reported in either of the clinical trials. The most frequently reported treatment-related undesirable effect with TRAVATAN eye drops (polyquaternium-1-preserved) was hyperaemia of the eye (18.9%), which included ocular or conjunctival hyperaemia. One patients (0.5%) discontinued study participation due to hyperaemia of the eye.
The following adverse reactions have been reported during clinical studies with Travoprost 40 µg/ml Eye Drops, Solution and are classified according to the subsequent convention: very common (≥ 1/10), common (≥ 1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) and very rare (<1/10,000). Within each frequency- grouping, adverse reactions are presented in order of decreasing seriousness.
Additional adverse reactions identified from post-marketing surveillance include the following. Frequencies cannot be estimated (not known) from the available data. (see table).
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