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Karlova E.V.

Samara Regional Clinical Ophthalmological Hospital named after T.I. Eroshevsky

Petrov S.Yu.

Research Institute of Eye Diseases

Germanova V.N.

Samara Regional Clinical Ophthalmological Hospital named after T.I. Eroshevsky

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

Authors:

Karlova E.V., Petrov S.Yu., Germanova V.N.

More about the authors

Journal: Russian Annals of Ophthalmology. 2020;136(4): 76‑84

DOI: 10.17116/oftalma202013604176

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To cite this article:

Karlova EV, Petrov SYu, Germanova VN. Preservative-free fixed combination in the treatment of open-angle glaucoma and ocular hypertension: the VISIONARY Study (EUPAS22204). Russian Annals of Ophthalmology. 2020;136(4):76‑84. (In Russ.)
https://doi.org/10.17116/oftalma202013604176

Подписка 2025 (Russian Annals of Ophthalmology)
 
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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 (p<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 (p<0.0010), irritation (p=0.0204) and itching (p=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.

Keywords:

fixed-dose combination
glaucoma
ocular hypertension
preservative-free topical medication
tafluprost
timolol

Authors:

Karlova E.V.

Samara Regional Clinical Ophthalmological Hospital named after T.I. Eroshevsky

Petrov S.Yu.

Research Institute of Eye Diseases

Germanova V.N.

Samara Regional Clinical Ophthalmological Hospital named after T.I. Eroshevsky

Received:

20.05.2020

Accepted:

07.06.2020

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