Pharmacology: Bioequivalence study: A partially shielded, parallel-group comparison study was conducted in patients with primary open-angle glaucoma or ocular hypertension. One drop/dose of TRAVOPROST OPHTHALMIC SOLUTION 0.004%W/V or a reference product (ophthalmic solution, 0.004%) was instilled in both eyes once daily for 4 weeks, and the intraocular pressure was measured. When the obtained data (Parameter: a change in the intraocular pressure from the baseline measured at 10:00 in Week 4 of the treatment phase (TRAVOPROST OPHTHALMIC SOLUTION 0.004%W/V: 22.09 ± 2.13 mmHg, Reference product (ophthalmic solution, 0.004%): 21.86 ± 2.25 mmHg) were statistically analyzed using the 95% confidence interval approach, the result was within the acceptable bioequivalent range of ±1.5 mmHg. Thus, these drugs were validated to be biologically equivalent. (See Table 1.)
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