[Preservative-free fixed combination in the treatment of open-angle glaucoma and ocular hypertension: the VISIONARY Study (EUPAS22204)].

UNLABELLED

Preservative-free fixed combination of 0.0015% Tafluprost and 0.5% Timolol (PF tafluprost/timolol FC) has demonstrated good antihypertensive effect and patient tolerance in randomized controlled clinical trials.

PURPOSE

To evaluate efficacy, tolerability, and safety of PF tafluprost/timolol FC in patients with primary open-angle glaucoma (POAG) and ocular hypertension (OH) who couldn't tolerate or gave insufficient response to topical beta-adrenoblockers or prostaglandin analogue monotherapy.

MATERIAL AND METHODS

The prospective multicenter European VISIONARY study (EUPAS22204) included 87 patients from 7 ophthalmological centers in Russia with mean age of 63.9±11.8. Primary endpoint was mean IOP change at month 6. The patients were monitored for changes in in the severity of ocular signs and symptoms.

RESULTS

Statistically significant (<0.0001) reduction of mean IOP from baseline was seen at all study visits: 7.3±5.17 mmHg at week 4, 7.4±5.40 mmHg at week 12, and 7.1±5.10 mmHg at month 6. By month 6, IOP has decreased by 20; 25; 30 and 35% from baseline in 77.0%, 58.9%, 43.7%, and 31.0% of study patients, respectively. Conjunctival hyperemia was significantly reduced at all study visits. Significant reductions in dry eye symptoms (<0.0010), irritation (=0.0204) and itching (=0.0010) were also observed. After 6 months on PF tafluprost/timolol FC, 85.7% of patients described it as easy or very easy to tolerate.

CONCLUSION

In clinical practice, PF tafluprost/timolol FC provided statistically significant IOP reductions in patients with POAG and OH insufficiently controlled by or intolerant to monotherapy with topical beta-adrenoblockers or a prostaglandin analogue. The highest IOP reduction was seen at week 4 and was maintained over the 6-month study period. There was also a decrease in the severity of symptoms of ocular surface condition.