Effect of preservative-free tafluprost on keratocytes, sub-basal nerves, and endothelium: a single-blind one-year confocal study on naïve or treated glaucoma and hypertensive patients versus a control group.

PURPOSE: To record the impact of preservative-free Tafluprost on corneal status examined by in vivo confocal microscopy. METHODS: A prospective cohort study on consecutive naïve or previously treated patients with a new prescription of preservative-free Tafluprost. All subjects underwent a complete ophthalmic examination [comprehensive of intraocular pressure (IOP) and central corneal thickness (CCT) measurements], and an in vivo corneal confocal microscopy evaluation, at baseline and 12 months later. A healthy control group was selected and examined at the same time. RESULTS: Seventy-five subjects (16 controls, 20 naïve, and 39 treated) were enrolled. At baseline, IOP was 16 (13.8-18.6), 21.5 (18-23.7), and 18 (16-22) mmHg, (P=0.01); and CCT did not differ among the groups (P=0.25). Epithelial cells, keratocyte activation, a number of sub-basal nerves, and the grade of nerve tortuosity were similar (P=0.233, 0.11, 0.417, and 0.05, respectively), in naïve and controls, while previously treated patients had significantly less epithelial cells and sub-basal corneal nerves (P<0.0001), keratocyte activation, increased number of bead-like formations, and nerve tortuosity (P<0.0001). At month 12, IOP decreased in both patient groups (P<0.001); CCT did not change. Previously treated patients showed an improvement in confocal parameters: increased epithelial cells (P=0.0006), reduced keratocyte activation (P=0.003), increased number of corneal nerves (P=0.0004), decreased number of bead-like formations (P=0.0013), and nerve tortuosity (P=0.0008). Naïve patients did not show significant changes. CONCLUSION: The study confirmed the efficacy of preservative-free Tafluprost in reducing IOP, and underlined the drug's safety in naïve glaucoma patients with regard to corneal status. In the balance between efficacy and tolerability, formulations with low cytotoxicity may ensure fewer side effects, with higher tolerability and better compliance.

Efficacy and ocular surface tolerability of preservative-free tafluprost 0.0015%: a 6-month, single-blind, observational study on naïve ocular hypertension or glaucoma patients.

OBJECTIVES: The aim of this study was to evaluate the safety of preservative-free tafluprost in newly diagnosed patients and to confirm its efficacy in lowering intraocular pressure (IOP). METHODS: Naïve patients were submitted to an ophthalmic examination, including ocular surface status and quality of life evaluation. All examinations were performed at baseline and after 1 and 6 months. RESULTS: 28 patients were enrolled and treated with tafluprost, once a day, in the evening. TF-BUT changed from 9 (interquartile range (IQR) 6 - 11) s at baseline to 10 (IQR 7 - 10) s at 1 month (p = 0.106) and 9 (IQR 6 - 12) s at 6 months (p = 0.003). No eye developed corneal staining. Quality of life was (median (IQR)) 91.6 (79.2 - 95.8) at baseline and 95.8 (66.7 - 100) at 6 months (p = 0.62). Only a few adverse events occurred during the follow-up period (three patients experienced ocular burning and one developed redness). The mean IOP reduction was 5.5 mm Hg (95% CI 3.8 - 7.2). The median (IQR) baseline IOP was 18.7 (15 - 23.7) mm Hg; 14 (13 - 16) mm Hg and 16 (14 - 16) mm Hg (p < 0.0001) after 1 and 6 months, respectively. CONCLUSION: No patient developed ocular surface disease and quality of life perception was preserved. Preservative-free tafluprost is therefore an effective drug that is safe for the ocular surface after 6 months of daily therapy.

Evaluation of prostaglandin analogue effects on corneal keratocyte density using scanning laser confocal microscopy.

PURPOSE: To determine if treatment with prostaglandin (PG) analogues affects keratocyte density as an indirect measure of extracellular matrix in the corneal stroma. PATIENTS AND METHODS: In this case control study, 129 eyes from 68 patients were examined: 52 eyes had only PG analogue therapy for at least 3 years, 37 eyes had only ß-adrenergic blocker therapy for at least 3 years, and 40 control eyes were without therapy. Scanning laser confocal microscopy was carried out, and each corneal stroma was subdivided into the anterior, midstroma, and posterior stroma. Keratocyte density was determined from the images by manual counting. RESULTS: Keratocyte densities in the entire stroma and in 2 stromal layers were significantly higher in patients with PG analogue therapy compared with control patients (entire stroma, P<0.001; anterior stroma, P=0.001; posterior stroma, P=0.016). Keratocyte density in the PG analogue therapy patients was also greater compared with the ß-adrenergic blocker patients (entire stroma, P<0.001; anterior stroma, P<0.001; mid-stroma P=0.023, posterior stroma P=0.007). There were no significant differences between the control and ß-adrenergic blocker groups. Overall, the density increase for the PG analogue group was greatest in the anterior stroma. CONCLUSIONS: PG analogue therapy increased the keratocyte density in each layer of corneal stroma, but more significantly in the anterior stroma than in the midstroma or the posterior stroma. The increased keratocyte density might be the result of diminished extracellular matrix, possibly owing to the known activation of matrix metalloproteinases and inhibition of tissue inhibitors of the metalloproteinases.

Ocular hypotensive efficacy and safety of travoprost 0.004% in inadequately controlled primary open-angle glaucoma or ocular hypertension: short-term, multicenter, prospective study.

OBJECTIVE: To evaluate the intraocular pressure (IOP) lowering efficacy and safety of travoprost 0.004% in patients with open-angle glaucoma or ocular hypertension, poorly controlled with or intolerance to beta-blockers. To record the short-term effect on diastolic ocular perfusion pressure (DOPP). RESEARCH DESIGN AND METHODS: One hundred and three patients with open-angle glaucoma or ocular hypertension were treated with travoprost 0.004% once daily for 90 days in an open-label, non-controlled study. Efficacy and safety were assessed at baseline, after 45 and 90 days. Clinical registry number IT0301. MAIN OUTCOME MEASURES: The primary outcome measure, IOP, was recorded at 10 am, 12 pm, and 4 pm at each visit. DOPP was evaluated at 10 am, at baseline and visit 3. Safety measures included adverse events, biomicroscopy, visual acuity, heart rate, and blood pressure. RESULTS: Mean IOP was reduced from 22.2 +/- 1.7 mmHg to 16.5 +/- 2.1 after 45 days (p < 0.0001), and to 16.1 +/- 2.2 after 90 days (p < 0.0001). The DOPP increased by 5.3 +/- 6.3 mmHg after 90 days of treatment (p < 0.0001). No drug related serious adverse events were reported during the study. CONCLUSIONS: The open-label and non-comparative nature of the study represented its principal limitations. The study confirmed the efficacy and tolerability of travoprost in the treatment of open-angle glaucoma or ocular hypertension, in a subset of patients unsuccessfully treated with beta-blockers. In this study, travoprost significantly increased DOPP at short-term follow-up. Further studies to assess the effect of travoprost on DOPP are warranted.

Prevalence of normal tension glaucoma in obstructive sleep apnea syndrome patients.

PURPOSE: To explore the prevalence of normal tension glaucoma (NTG) among patients with obstructive sleep apnea syndrome (OSAS) and to examine OSAS as a risk factor of NTG. PATIENTS AND METHODS: Fifty-one consecutive white patients with OSAS were compared with 40 healthy subjects. All the study subjects underwent blood gas analysis, polysomnography, oxyhemoglobin saturation, and an ophthalmologic examination including visual field, visually evoked potential (VEP), and pattern electroretinography (PERG) and disc analysis with the Heidelberg Retina Tomograph II. RESULTS: Three of 51 OSAS patients (5.9%) had NTG. No patient in the control group had OSAS or NTG. The severity of OSAS correlated with intraocular pressure, the mean deviation of the visual field, the cup/disk ratio and the mean of the retinal nerve fiber layer thickness (P<0.01 to 0.001). Apnea hypopnea index and intraocular pressure were significantly greater in OSAS patients with abnormal VEP and PERG, compared to those with normal PERG and VEP. CONCLUSIONS: The present study suggests that the prevalence of NTG in our OSAS patients is higher than expected in a white population of the same age and that OSAS may be an important risk factor for NTG. Our data underline the importance of taking an accurate sleep history from patients with NTG and referring patients with sleep disturbance for polysomnography.