Preservative-free tafluprost in the treatment of naive patients with glaucoma and ocular hypertension

Abstract

PurposeThe study reported here investigated the efficacy, tolerability, and safety of the preservative-free prostaglandin analog tafluprost 0.0015% in treatment-naive patients.Patients and methodsData were collected in two non-interventional, prospective, multicenter, observational, open-label studies of identical design that were conducted in Germany and the Czech Republic. All subjects received preservative-free tafluprost 0.0015% once daily. Intraocular pressure (IOP) levels were recorded for each eye at untreated baseline and 3 months after initiation of medical treatment. The primary outcome was change in mean IOP from baseline to month 3. In the primary open-angle glaucoma (POAG) and ocular hypertension (OH) patient subgroups, analyses were stratified by the level of baseline IOP: ≥20 to 23 mmHg versus ≥24 mmHg. In addition, responder rates and the achievement of pre-specified IOP levels at month 3 were evaluated. Local tolerance of preservative-free tafluprost was evaluated by the patients at final visit. Overall satisfaction with the medical treatment was evaluated by both patients and physicians. All adverse events were recorded.ResultsA total of 579 treatment-naive patients with POAG (n = 349), OH (n = 105), normal tension glaucoma (n = 71), exfoliative glaucoma (n = 27), or other glaucomas (n = 27) were included in this observational study. Mean IOP level at baseline for all patients was 23.6 ± 4.0 mmHg. Mean IOP at month 3 was 16.8 ± 2.9 mmHg (−28.8% vs baseline). At month 3, significant reductions in mean IOP (P < 0.001) were seen in all patients and all subgroups. Preservative-free tafluprost lowered mean IOP significantly in patients with POAG and OH with IOP levels ≥ 20 to 23 mmHg from 21.9 ± 1.1 mmHg at baseline to 16.5 ± 2.2 mmHg, and in the subgroup with IOP levels ≥ 24 mmHg from 26.2 ± 2.4 mmHg to 17.9 ± 2.4 mmHg. In the subgroups of patients with POAG and OH, an IOP response ≥20%, ≥30%, and ≥40% was achieved by 83.4%, 44.1%, and 12.8%, respectively. Overall, patients with higher baseline IOP values showed a better response than patients with lower baseline IOP levels. Preservative-free tafluprost was well tolerated and safe. After 3 months, 97.9% of all patients remained on therapy.ConclusionIn this real-world observational study, treatment with once-daily preservative-free tafluprost proved efficacious, well tolerated, and safe in treatment-naive patients.

Newly Diagnosed Primary Open-Angle Glaucoma Randomized to 2 Trabecular Bypass Stents or Prostaglandin: Outcomes Through 36 Months

“…In this study, the IOP decrease in the travoprost group was greater than the 25–35% IOP reductions reported in prior work [33–35]. This may be due to medication-naïve eyes, high compliance due to study participation, and/or regression to the mean.…”

“…This may be due to medication-naïve eyes, high compliance due to study participation, and/or regression to the mean. The greater IOP reduction also may be attributed to the pre-treatment IOP level (i.e., greater IOP reduction with higher preoperative IOP), a phenomenon which has been reported previously in both treated and treatment-naïve glaucoma patients [35, 36]. …”

Efficacy and tolerability of preservative-free tafluprost 0.0015% in Korean patients with glaucoma

“…I read with interest the article entitled “Preservative-free tafluprost in the treatment of naive patients with glaucoma and ocular hypertension” by Lanzl et al1 I have also experienced similar treatment outcomes in Korean patients. In Korea, preservative-free tafluprost (Taflotan-S; Santen Pharmaceutical Co, Ltd, Osaka, Japan) was introduced to the ophthalmic market in October 2012.…”

Comparison of Ocular Pulse Amplitude Lowering Effects of Preservative-Free Tafluprost and Preservative-Free Dorzolamide-Timolol Fixed Combination Eyedrops

“…Benzalkonium chloride (BAK), which is widely used in glaucoma preparations as a preservative, damages the tear film and has a negative impact on the number of conjunctival goblet cells. For this reason, over 50% of patients treated for glaucoma have concurrent ocular surface disorders [ 9 ].…”