Prospective Observational Post-marketing Study of Tafluprost 0.0015%/Timolol 0.5% Combination Ophthalmic Solution for Glaucoma and Ocular Hypertension: Short-Term Efficacy and Safety

Abstract

IntroductionThe intraocular pressure (IOP)-lowering effect and safety of tafluprost 0.0015%/timolol maleate 0.5% combination ophthalmic solution (Taf–TFC) were investigated in a real-world clinical setting.MethodsA prospective up to 2-year (more than 1 year) observational study has been initiated to collect data on the IOP, conjunctival hyperemia score, corneal staining score, and adverse events suffered by patients with glaucoma or ocular hypertension treated at 3 months, and up to 2 years (more than 1 year) after initiating treatment with Taf–TFC. The 3-month findings are reported here.ResultsAmong 439 patients enrolled at 100 institutions in Japan, most had normal tension glaucoma (45.3%) or primary open angle glaucoma (36.0%). Adverse drug reaction (ADR) occurred in 5.01%. The important ADRs were conjunctival hyperemia (five patients), blepharitis (four patients), and punctate keratitis (two patients). Serious adverse reactions occurred in two patients (three events). In 410 patients with data both before and after treatment, baseline mean IOP was 17.5 ± 5.0 mmHg, and it was significantly decreased after 1, 2, and 3 months (all P < 0.05, paired-t test). IOP was significantly reduced in patients switched to Taf–TFC from either prostaglandin or β-blocker monotherapy. IOP also decreased significantly in patients switched from a prostaglandin/timolol fixed combination, but not in patients switched from concomitant use of a prostaglandin analog and a β-blocker. The use of Taf–TFC did not worsen the adherence in most patients.ConclusionTaf–TFC significantly reduced the IOP in patients with glaucoma or ocular hypertension treated in daily clinical practice with controllable or recoverable ADRs in short period. Taf–TFC was effective regardless of treatment patterns, and particularly, Taf–TFC significantly reduced IOP in cases in which requiring the second line therapy as insufficient of monotherapy.FundingSanten Pharmaceutical Co., Ltd., Osaka, Japan.

The signs of ocular-surface disorders after switching from latanoprost to tafluprost/timolol fixed combination: a prospective study

“…As a result, no statistically significant differences in IOP were observed between the beginning (week −12) and the end (week 0) of the latanoprost phase. After switching to TTFC, a significant decrease in IOP was observed at weeks 4 and 12 compared with week 0, as reported previously 5,6,13. These findings suggest that the IOP reduction observed in this study is an additive effect of the β-blocker, timolol, and not a result of improved adherence.…”

Changes in adherence and associated factors among patients on newly introduced prostaglandin analog and timolol fixed-combination therapy

“…Poor adherence is recognized as one of the most important problems with medical treatment for glaucoma patients in real-world situations. According to many previous studies, several factors affect adherence, and some studies have reported that an increase in the number of eye drops used is negatively associated with adherence 2–10. Therefore, reducing the number of ocular hypotensive eye drops may improve adherence.…”

Efficacy and Safety of Switching Prostaglandin Analog Monotherapy to Tafluprost/Timolol Fixed-Combination Therapy

“…Fixed-combination ophthalmic solutions have been gaining approval for clinical use, and six of these solutions are currently available in Japan. The tafluprost/timolol fixed-combination solution (Taf/Tim) has been shown to significantly reduce IOP in patients with glaucoma [ 7 ]. The amount of benzalkonium chloride (BAC) was positively correlated with ocular surface injury.…”